Trial Outcomes & Findings for Does Virtual Reality Technology Reduce Pain and Anxiety During Outpatient Hysteroscopy? (NCT NCT05307887)

NCT ID: NCT05307887

Last Updated: 2024-08-09

Results Overview

Self reported procedure related pain score (0-11 with higher numbers indicating increased pain).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 83 participants
• Primary outcome timeframe: Following completion of the procedure( within 20 minutes of completion).
• Results posted on: 2024-08-09

Participant Flow

Recruitment was performed between April and October 2022 at St Mary's Hospital London gynaecology clinics.

Participant milestones

Measure	Virtual Reality Technology Group receiving virtual reality technology in addition to standard therapy Sync VR Medical PICO G2 4K Virtual Reality Technology: Virtual reality headset and software	Standard Therapy Control Group Group receiving standard care including simple analgesia prior to procedure.
Overall Study STARTED	41	42
Overall Study COMPLETED	41	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Virtual Reality Technology n=41 Participants Group receiving virtual reality technology in addition to standard therapy Sync VR Medical PICO G2 4K Virtual Reality Technology: Virtual reality headset and software	Standard Therapy Control Group n=42 Participants Group receiving standard care	Total n=83 Participants Total of all reporting groups
Sex: Female, Male Male	0 Participants n=41 Participants	0 Participants n=42 Participants	0 Participants n=83 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Parity	0.9 pregnancies STANDARD_DEVIATION 1.2 • n=41 Participants	1.1 pregnancies STANDARD_DEVIATION 1.4 • n=42 Participants	1.1 pregnancies STANDARD_DEVIATION 1.4 • n=83 Participants
Number of Post-menopausal Participants	16 Participants n=41 Participants	17 Participants n=42 Participants	33 Participants n=83 Participants
Age, Continuous	47.8 years STANDARD_DEVIATION 11.3 • n=41 Participants	49.6 years STANDARD_DEVIATION 11.3 • n=42 Participants	48.7 years STANDARD_DEVIATION 10.3 • n=83 Participants
Sex: Female, Male Female	41 Participants n=41 Participants	42 Participants n=42 Participants	83 Participants n=83 Participants
Body mass index	26.4 kg/m2 STANDARD_DEVIATION 6.2 • n=41 Participants	26.8 kg/m2 STANDARD_DEVIATION 6.1 • n=42 Participants	26.6 kg/m2 STANDARD_DEVIATION 6.1 • n=83 Participants
History of chronic pain	3 Participants n=41 Participants	5 Participants n=42 Participants	8 Participants n=83 Participants
History of anxiety	2 Participants n=41 Participants	5 Participants n=42 Participants	7 Participants n=83 Participants
Baseline anxiety levels	4.0 units on a scale STANDARD_DEVIATION 3.2 • n=41 Participants	4.4 units on a scale STANDARD_DEVIATION 3.0 • n=42 Participants	4.2 units on a scale STANDARD_DEVIATION 3.0 • n=83 Participants
Baseline pain level	2.5 units on a scale STANDARD_DEVIATION 2.9 • n=41 Participants	2.5 units on a scale STANDARD_DEVIATION 2.7 • n=42 Participants	2.5 units on a scale STANDARD_DEVIATION 2.8 • n=83 Participants
Preprocedure analgesia	33 Participants n=41 Participants	37 Participants n=42 Participants	70 Participants n=83 Participants

PRIMARY outcome

Timeframe: Following completion of the procedure( within 20 minutes of completion).

Self reported procedure related pain score (0-11 with higher numbers indicating increased pain).

Outcome measures

Measure	Virtual Reality Technology n=41 Participants Group receiving virtual reality technology in addition to standard therapy Sync VR Medical PICO G2 4K Virtual Reality Technology: Virtual reality headset and software	Standard Therapy Control Group n=42 Participants Group receiving standard care including simple analgesia prior to procedure.
Reported Numeric Rating Score (NRS) Pain Score	3.73 units on a scale Standard Deviation 2.39	4.24 units on a scale Standard Deviation 3.07

PRIMARY outcome

Timeframe: Following completion of the procedure( within 20 minutes of completion).

Self reported procedure related anxiety score (0-11 with higher numbers indicating higher anxiety levels).

Outcome measures

Measure	Virtual Reality Technology n=41 Participants Group receiving virtual reality technology in addition to standard therapy Sync VR Medical PICO G2 4K Virtual Reality Technology: Virtual reality headset and software	Standard Therapy Control Group n=42 Participants Group receiving standard care including simple analgesia prior to procedure.
Reported Numeric Rating Score (NRS) Anxiety Score	3.29 units on a scale Standard Deviation 2.93	4.79 units on a scale Standard Deviation 3.38

SECONDARY outcome

Timeframe: From start to end of procedure

Time taken to complete hysteroscopy procedure

Outcome measures

Measure	Virtual Reality Technology n=41 Participants Group receiving virtual reality technology in addition to standard therapy Sync VR Medical PICO G2 4K Virtual Reality Technology: Virtual reality headset and software	Standard Therapy Control Group n=42 Participants Group receiving standard care including simple analgesia prior to procedure.
Procedure Time	9.5 minute Standard Deviation 5	7.6 minute Standard Deviation 3.7

SECONDARY outcome

Timeframe: Following completion of the procedure( within 20 minutes of completion).

Self reported procedure related satisfaction score (0-11 with higher numbers indicating higher patient satisfaction with the procedure).

Outcome measures

Measure	Virtual Reality Technology n=41 Participants Group receiving virtual reality technology in addition to standard therapy Sync VR Medical PICO G2 4K Virtual Reality Technology: Virtual reality headset and software	Standard Therapy Control Group n=42 Participants Group receiving standard care including simple analgesia prior to procedure.
Patient Pain Control Satisfaction	8.4 units on a scale Standard Deviation 2.3	8.5 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: during procedure

Any side effects or complications that occurred in each group.

Outcome measures

Measure	Virtual Reality Technology n=41 Participants Group receiving virtual reality technology in addition to standard therapy Sync VR Medical PICO G2 4K Virtual Reality Technology: Virtual reality headset and software	Standard Therapy Control Group n=42 Participants Group receiving standard care including simple analgesia prior to procedure.
Side Effects	2 Participants	3 Participants

Adverse Events

Virtual Reality Technology

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard Therapy Control Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Virtual Reality Technology n=41 participants at risk Group receiving virtual reality technology in addition to standard therapy Sync VR Medical PICO G2 4K Virtual Reality Technology: Virtual reality headset and software	Standard Therapy Control Group n=42 participants at risk Group receiving standard care including simple analgesia prior to procedure.
Gastrointestinal disorders Nausea	4.9% 2/41 • Number of events 2 • Data was collected for each participant for the duration of their hysteroscopy procedure until they left the clinic (approx 30-60mins).	4.8% 2/42 • Number of events 2 • Data was collected for each participant for the duration of their hysteroscopy procedure until they left the clinic (approx 30-60mins).
Cardiac disorders vasovagal	0.00% 0/41 • Data was collected for each participant for the duration of their hysteroscopy procedure until they left the clinic (approx 30-60mins).	2.4% 1/42 • Number of events 1 • Data was collected for each participant for the duration of their hysteroscopy procedure until they left the clinic (approx 30-60mins).

Additional Information

Dr Thomas Sewell

Imperial College NHS Foundation Trust

Phone: 02033122152

Email: thomas.sewell2@nhs.net

Results disclosure agreements

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