Trial Outcomes & Findings for A Proof-of-concept Study to Reduce Treatment Burden in Haemophilia Participants Receiving Factor VIII and Factor IX Infusions (NCT NCT05437211)

NCT ID: NCT05437211

Last Updated: 2025-06-05

Results Overview

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10-centimeter (cm) line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: At Week 4
• Results posted on: 2025-06-05

Participant Flow

Participants took part in the study at the 6 centres in France from 23 June 2023 to 21 February 2024.

A total of 24 male participants with Congenital Haemophilia A or B were enrolled in this study.

Participant milestones

Measure	Virtual Reality (VR)-Based Experimental Group: With Autonomy Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device Conformité Européene (CE) marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Overall Study STARTED	14	10
Overall Study Included Set (IS)	14	10
Overall Study Full Analysis Set (FAS)	13	9
Overall Study COMPLETED	13	9
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Virtual Reality (VR)-Based Experimental Group: With Autonomy Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device Conformité Européene (CE) marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Overall Study Patient's decision	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	VR-based Experimental Group: With Autonomy n=14 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=10 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	Total n=24 Participants Total of all reporting groups
Age, Continuous	39.3 years STANDARD_DEVIATION 20.6 • n=14 Participants	13.9 years STANDARD_DEVIATION 10.6 • n=10 Participants	28.7 years STANDARD_DEVIATION 21.2 • n=24 Participants
Sex: Female, Male Female	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Sex: Female, Male Male	14 Participants n=14 Participants	10 Participants n=10 Participants	24 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints for the categories.

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10-centimeter (cm) line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Mean Absolute Values of Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before Each Factor VIII or Factor IX Infusion in Participants and Caregivers A-VAS before infusion For Participants	0.2 score on a scale Standard Deviation 0.4	—
Mean Absolute Values of Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before Each Factor VIII or Factor IX Infusion in Participants and Caregivers A-VAS before infusion For Caregivers	1.5 score on a scale Standard Deviation 2.0	0.0 score on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: Baseline up to Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure were planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy). Here, "number analyzed" signifies participants who were evaluable at specified timepoints for the categories.

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety. Participants are categorized based on their A-VAS score values at both Baseline (-5, -3, 0, and 9.1) and Week 4 (-5, -2.3, -1, 0 and 2). The A-VAS score reported within each category represent the mean difference between the score collected after and before infusion (after minus before). A negative value indicates an improvement in anxiety compared to the baseline score, while a positive value indicates a worsening of anxiety compared to the baseline score.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=22 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (-5) and Week 4 (-5)	0 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (-5) and Week 4 (-2.3)	1 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (-5) and Week 4 (-1)	1 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (-5) and Week 4 (0)	2 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (-5) and Week 4 (2)	0 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (-3) and Week 4 (-5)	0 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (-3) and Week 4 (-2.3)	0 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (-3) and Week 4 (-1)	0 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (-3) and Week 4 (0)	1 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (-3) and Week 4 (2)	1 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (0) and Week 4 (-5)	1 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (0) and Week 4 (-2.3)	0 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (0) and Week 4 (-1)	0 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (0) and Week 4 (0)	14 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (0) and Week 4 (2)	0 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (9.1) and Week 4 (-5)	0 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (9.1) and Week 4 (-2.3)	0 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (9.1) and Week 4 (-1)	0 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (9.1) and Week 4 (0)	1 Participants	—
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion Participants with variation of the anxiety VAS values between Baseline (9.1) and Week 4 (2)	0 Participants	—

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure was planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy).

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=22 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants With Decrease of 2 Points Out of 10 Points in the A-VAS Scale Before Each Factor VIII or Factor IX Infusion	5 Participants	—

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available.

The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Mean Absolute Values of the Pain Measured by a Pain Visual Analogue Scale (P-VAS) After Each Factor VIII or Factor IX Infusion in Participants	1.4 score on a scale Standard Deviation 2.7	0.6 score on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline up to Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure were planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy). Here, "number analyzed" signifies participants who were evaluable at specified timepoints for the categories.

The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain. Participants are categorized based on P-VAS score values at both Baseline (0, 1.3, 2, 4 and 5) and Week 4 (0, 0.2, 0.4, 5 and 8). A positive value indicates worsening in pain compared to the baseline score.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=22 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (0) and Week 4 (0)	13 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (4) and Week 4 (0)	2 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (0) and Week 4 (0.2)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (0) and Week 4 (0.4)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (0) and Week 4 (5)	1 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values Baseline (0) and Week 4 (8)	1 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (1.3) and Week 4 (0)	1 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (1.3) and Week 4 (0.2)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (1.3) and Week 4 (0.4)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (1.3) and Week 4 (5)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (1.3) and Week 4 (8)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (2) and Week 4 (0)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (2) and Week 4 (0.2)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (2) and Week 4 (0.4)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (2) and Week 4 (5)	1 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (2) and Week 4 (8)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (4) and Week 4 (0.2)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (4) and Week 4 (0.4)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (4) and Week 4 (5)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (4) and Week 4 (8)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (5) and Week 4 (0)	0 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (5) and Week 4 (0.2)	1 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (5) and Week 4 (0.4)	1 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (5) and Week 4 (5)	1 Participants	—
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion Participants with absolute variation of the P-VAS values between Baseline (5) and Week 4 (8)	0 Participants	—

PRIMARY outcome

Timeframe: Baseline up to Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure was planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy).

The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=22 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants With a Decrease of 2 Points Out of 10 Points in the P-VAS Scale After Each Factor VIII or Factor IX Infusion	4 Participants	—

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=9 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Mean Absolute Values of Anxiety Measured by an A-VAS Scale After Each Factor VIII or Factor IX Infusion in Participants and Caregivers A-VAS after infusion for participants	0.2 score on a scale Standard Deviation 0.4	—
Mean Absolute Values of Anxiety Measured by an A-VAS Scale After Each Factor VIII or Factor IX Infusion in Participants and Caregivers A-VAS after infusion for caregivers	0.8 score on a scale Standard Deviation 2.0	0.0 score on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: Baseline up to Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure was planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy).

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety and negative value indicated worst health.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=22 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants With a Decrease of 2 Points Out of 10 Points in the A-VAS Scale After Each Factor VIII or Factor IX Infusion	2 Participants	—

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to adult participants to assess the effect of the treatment on the participants' quality of life. Adult participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-3L index score indicated improvement and negative value indicated worst health.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=9 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=5 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Absolute Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score Absolute Variation for adult participants	0.0 score on a scale Standard Deviation 0.2	-0.0 score on a scale Standard Deviation 0.1
Absolute Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score Absolute Variation for caregivers	0.3 score on a scale Standard Deviation 0.1	-0.0 score on a scale Standard Deviation 0.1

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to adult participants to assess the effect of the treatment on the participants' quality of life. Adult participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-3L index score indicated improvement and negative value indicated worst health. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=9 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=5 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Relative Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score Relative Variation for adult participants	7.1 percentage Standard Deviation 32.7	-5.1 percentage Standard Deviation 7.2
Relative Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score Relative Variation for caregivers	61.0 percentage Standard Deviation 34.8	-2.0 percentage Standard Deviation 11.8

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here" overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and" number analyzed" signifies participants who were evaluable at specified timepoints.

The EQ-5D-Y is a standardized instrument for use as a measure of health outcome and was administered to youth participants to assess the effect of the treatment on the participants' quality of life. Youth participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-Y index score indicated improvement and negative value indicated worst health.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=4 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=7 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Absolute Variation of Youth Participants Quality of Life Measured With the European Quality of Life 5 Dimensions For Youth (EQ-5D-Y) Health State Index Score	-0.1 score on a scale Standard Deviation 0.2	-0.1 score on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here" overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and" number analyzed" signifies participants who were evaluable at specified timepoints.

The EQ-5D-Y is a standardized instrument for use as a measure of health outcome and was administered to youth participants to assess the effect of the treatment on the participants' quality of life. Youth participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-Y index score indicated improvement and negative value indicated worst health. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=4 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=7 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Relative Variation of Youth Participants Quality of Life Measured With the European Quality of Life 5 Dimensions For Youth (EQ-5D-Y) Health State Index Score	-21.2 percentage Standard Deviation 35.3	-12.8 percentage Standard Deviation 32.8

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

EQ-5D-3L health questionnaire is adult participant and caregivers and EQ-5D-Y is a youth participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =extreme problems) in the relevant health dimension. Higher score indicated a worsening health condition.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants and Caregivers With a Decrease of 2 Points in the EQ-5D-3L VAS and EQ-5D-Y Score EQ-5D-3L Score for Participants	0 Participants	0 Participants
Number of Participants and Caregivers With a Decrease of 2 Points in the EQ-5D-3L VAS and EQ-5D-Y Score EQ-5D-3L Score for Caregivers	0 Participants	0 Participants
Number of Participants and Caregivers With a Decrease of 2 Points in the EQ-5D-3L VAS and EQ-5D-Y Score EQ-5D-Y Score for Youth Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). Higher scores were positively correlated with higher levels of anxiety. Each type of anxiety has its own scale of 20 different questions and were rated on a 4-point scale (e.g. from 'Almost Never to 'Almost Always'). Low scores indicated a mild form of anxiety, and high scores indicated a severe form of anxiety. STAI score ranged from 20 to 80 where higher scores indicated greater anxiety and negative value indicated worst anxiety.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Absolute Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score Absolute variation of the STAI-Y1	-2.4 Score on a scale Standard Deviation 7.2	-1.5 Score on a scale Standard Deviation 3.9
Absolute Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score Absolute variation of the STAI-Y2	-2.9 Score on a scale Standard Deviation 3.1	-0.5 Score on a scale Standard Deviation 3.0

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). Higher scores were positively correlated with higher levels of anxiety. Each type of anxiety has its own scale of 20 different questions and were rated on a 4-point scale (e.g. from 'Almost Never to 'Almost Always'). Low scores indicated a mild form of anxiety, and high scores indicated a severe form of anxiety. STAI score ranged from 20 to 80 where higher scores indicated greater anxiety and negative value indicated worst anxiety. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Relative Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score Relative variation of the STAI-Y1	-6.6 percentage Standard Deviation 21.0	-3.7 percentage Standard Deviation 12.7
Relative Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score Relative variation of the STAI-Y2	-8.1 percentage Standard Deviation 8.1	-1.5 percentage Standard Deviation 10.2

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The STAI-S is a psychological assessment tool used to measure the level of anxiety a person is experiencing at a particular moment in time that assesses both State anxiety (STAI-Y1) and Trait anxiety (STAI-Y2). Each type of anxiety has its own scale of 20 different questions each that are scored on a 4-point scale evaluating how respondents feel "right now, at this moment" (e.g. from 'Almost Never to 'Almost Always'). Total scores for each (Y1 and Y2) range from 20 to 80, with higher scores correlating with greater anxiety. Severity for each STAI-Y1 and STAI-Y2 is defined by the scores on STAI-S: 20-35 (very low) 36-45 (low) 46-55 (moderate) 56-65 (high) 66-80 (very high). Number of participants with decrease of at least one level of State-Trait Anxiety Inventory- Severity (STAI-S) are reported.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of All Participants With Decrease of at Least One Level of State-Trait Anxiety Inventory Severity (STAI-S) Decrease from baseline of at least one level of anxiety state of STAI-Y1	3 Participants	2 Participants
Number of All Participants With Decrease of at Least One Level of State-Trait Anxiety Inventory Severity (STAI-S) Decrease from baseline of at least one level of anxiety state of STAI-Y2	4 Participants	1 Participants

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=8 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Absolute Variation of Participants Depression Measured by Patient Health Questionnaire (Module 9) (PHQ-9) Depression Severity	-1.3 score on a scale Standard Deviation 3.2	-1.4 score on a scale Standard Deviation 4.9

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=12 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=7 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Relative Variation of Participants Depression Measured by Patient Health Questionnaire (Module 9) (PHQ-9) Depression Severity	-13.7 percentage Standard Deviation 28.2	51.9 percentage Standard Deviation 161.2

PRIMARY outcome

Timeframe: Baseline up to Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=8 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants With Decrease of at Least One Level of Depression Severity Measured by PHQ-9 Scale	2 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants With Absolute Adherence to Infusions Measured by 4-Item Morisky Medication Adherence Scale (MMAS-4) Scores	7 Participants	6 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available.

The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants With Changes in Adherence to Infusions Measured by MMAS-4 by Classes Participants with changes in Medium adherence (2-3)	6 Participants	3 Participants
Number of Participants With Changes in Adherence to Infusions Measured by MMAS-4 by Classes Participants with changes in Low adherence (0-1)	0 Participants	0 Participants
Number of Participants With Changes in Adherence to Infusions Measured by MMAS-4 by Classes Participants with changes in High adherence (4)	7 Participants	6 Participants

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available.

The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behavior. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants Who Scored 4 (High Adherence) Using MMAS-4 Scale at Week 4	7 Participants	6 Participants

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

Adherence to the VR-based solution was assessed at Week 4 using the MMAS. The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 Participants with Low adherence (0-1)	1 Participants	0 Participants
Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 Participants with Medium adherence (2-3)	6 Participants	5 Participants
Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 Participants with High adherence (4)	6 Participants	4 Participants
Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 Caregivers with Low adherence (0-1)	0 Participants	0 Participants
Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 Caregivers with Medium adherence (2-3)	2 Participants	0 Participants
Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 Caregivers with High adherence (4)	1 Participants	5 Participants

PRIMARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The PGIC is a 7-point Likert scale, a verbal rating scale that asked the respondent to best describe change in symptoms compared to the beginning of study. Participants/caregivers selected from scale range of 1 (very much worsened) to 7 (very much improved). Higher score indicated improved outcome.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants With a Patients' Global Impression of Change (PGIC) Score Greater Than (>) 3 Among Participants and Caregivers PGIC: Patients (Score >3)	7 Participants	4 Participants
Number of Participants With a Patients' Global Impression of Change (PGIC) Score Greater Than (>) 3 Among Participants and Caregivers PGIC: Caregivers (Score >3)	2 Participants	2 Participants

SECONDARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

A 4-point Likert scale was used to assess the number of participants, caregivers, and investigators with a score of 3 or 4 (satisfied or very satisfied) with the use of the VR- based system. The Likert scale is composed from 1=never satisfied to 4=very satisfied.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants, With Satisfaction, Willingness to Continue the VR-Based Solution Measured by 4-point Likert Scale Score More Than and Equal to (>=3) Among Participants and Caregivers Satisfaction: Participants (Score >=3)	10 Participants	9 Participants
Number of Participants, With Satisfaction, Willingness to Continue the VR-Based Solution Measured by 4-point Likert Scale Score More Than and Equal to (>=3) Among Participants and Caregivers Satisfaction: Caregivers (Score >=3)	2 Participants	4 Participants

SECONDARY outcome

Timeframe: At Week 4

Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

Preference for the VR-based solution in participants and caregivers was assessed using a binary question: Yes (Preference for the VR-based solution) and No (preference for VR-based solution) was assessed.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=13 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=9 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers Preference for the VR-based solution - Caregivers · No	1 Participants	1 Participants
Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers Preference for the VR-based solution - Participants · Yes	5 Participants	7 Participants
Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers Preference for the VR-based solution - Participants · No	8 Participants	2 Participants
Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers Preference for the VR-based solution - Caregivers · Yes	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 4

Population: The IS included all eligible participants with or without assessment at the end of the Week 4 visit.

An incident is a minor hardware and/or software event that prevents the correct use of the solution in its context. The incidents were mainly associated with misuse by the user of the solution or with a software and/or hardware failure.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=14 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=10 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Incidents With the VR-Based Solution	3 number of incidents	1 number of incidents

SECONDARY outcome

Timeframe: From start of study up to Week 4

Population: The IS included all eligible participants with or without assessment at the end of the Week 4 visit.

An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. AEs related to infusions of Factor VIII or Factor IX or use of VR-based solution was assessed. An SAE is any untoward medical occurrence that at any dose: results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or any other medically important event that, in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.

Outcome measures

Measure	VR-based Experimental Group: With Autonomy n=14 Participants Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=10 Participants Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Number of Participants With Related Adverse Events (AEs) and Serious Adverse Events (SAEs) to the Infusions of Factor VIII or Factor IX or VR-Based Solution Participants with related AEs	0 Participants	0 Participants
Number of Participants With Related Adverse Events (AEs) and Serious Adverse Events (SAEs) to the Infusions of Factor VIII or Factor IX or VR-Based Solution Participants with SAEs	0 Participants	0 Participants

Adverse Events

VR-based Experimental Group: With Autonomy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

VR-based Experimental Group: Without Autonomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	VR-based Experimental Group: With Autonomy n=14 participants at risk Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.	VR-based Experimental Group: Without Autonomy n=10 participants at risk Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.
Nervous system disorders Headache	7.1% 1/14 • From start of study up to Week 4 The IS included all eligible participants with or without assessment at the end of the Week 4 visit.	0.00% 0/10 • From start of study up to Week 4 The IS included all eligible participants with or without assessment at the end of the Week 4 visit.
Musculoskeletal and connective tissue disorders Neck pain	7.1% 1/14 • From start of study up to Week 4 The IS included all eligible participants with or without assessment at the end of the Week 4 visit.	0.00% 0/10 • From start of study up to Week 4 The IS included all eligible participants with or without assessment at the end of the Week 4 visit.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place