Trial Outcomes & Findings for Virtual Reality and Outpatient Hysteroscopy (NCT NCT03699280)

NCT ID: NCT03699280

Last Updated: 2023-02-02

Results Overview

This outcome measure assessed the feasibility of using virtual reality as a distraction technique in the management of acute pain in patients undergoing Outpatient Hysteroscopy. 'Worst pain scores' indicated the most pain experienced during the procedure, even if momentary. It was based on a numeric rating score (11-point scale from 0 to 10; 0 representing 'no pain' and 10 representing 'worst imaginable pain'). The outcome value refers to the worst pain experienced by the participant during the Hysteroscopy procedure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: during the hysteroscopy procedure, an average of 10 minutes
• Results posted on: 2023-02-02

Participant Flow

Recruitments as defined in the protocol

Participant milestones

Measure	Virtual Reality VR video to be played during the procedure Virtual Reality: Oculus Go VR device	Standard Procedure Routine protocol outpatient hysteroscopy
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
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 n=20 Participants VR video to be played during the procedure Virtual Reality: Oculus Go VR device	Standard Procedure n=20 Participants Routine protocol outpatient hysteroscopy	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Continuous	31.3 years STANDARD_DEVIATION 5.2 • n=20 Participants	31.1 years STANDARD_DEVIATION 5.4 • n=20 Participants	31.2 years STANDARD_DEVIATION 5.3 • n=40 Participants
Sex: Female, Male Female	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Sex: Female, Male Male	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Menopausal Status Pre-menopausal	7 Participants n=20 Participants	7 Participants n=20 Participants	14 Participants n=40 Participants
Menopausal Status Post-menopausal	13 Participants n=20 Participants	13 Participants n=20 Participants	26 Participants n=40 Participants

PRIMARY outcome

Timeframe: during the hysteroscopy procedure, an average of 10 minutes

This outcome measure assessed the feasibility of using virtual reality as a distraction technique in the management of acute pain in patients undergoing Outpatient Hysteroscopy.

'Worst pain scores' indicated the most pain experienced during the procedure, even if momentary. It was based on a numeric rating score (11-point scale from 0 to 10; 0 representing 'no pain' and 10 representing 'worst imaginable pain'). The outcome value refers to the worst pain experienced by the participant during the Hysteroscopy procedure.

Outcome measures

Measure	Virtual Reality n=20 Participants VR video to be played during the procedure Virtual Reality: Oculus Go VR device	Standard Procedure n=20 Participants Routine protocol outpatient hysteroscopy
Worst Pain Scores	5.65 score on a scale Standard Deviation 2.4	7.85 score on a scale Standard Deviation 2.56

PRIMARY outcome

Timeframe: 10 minutes immediately before and after the procedure

This outcome measure assessed the average pain experienced by the participants during the hysteroscopy procedure with virtual reality intervention. The pain scores were based on numeric rating scores (11-point scale from 0 to 10; 0 representing 'no pain' and 10 representing 'worst imaginable pain').

Data from the two time points in the time frame were combined and calculated as an average.

Outcome measures

Measure	Virtual Reality n=20 Participants VR video to be played during the procedure Virtual Reality: Oculus Go VR device	Standard Procedure n=20 Participants Routine protocol outpatient hysteroscopy
Average Pain Scores	3.7 score on a scale Standard Deviation 2.66	6 score on a scale Standard Deviation 2.62

PRIMARY outcome

Timeframe: during the hysteroscopy procedure, an average of 10 minutes

Anxiety scores were measured on a numeric rating score (scale of 0-10, with 0 representing 'no anxiety' and 10 representing 'worst imaginable anxiety'). The anxiety scores measured during the procedure were reported in this outcome measure.

Outcome measures

Measure	Virtual Reality n=20 Participants VR video to be played during the procedure Virtual Reality: Oculus Go VR device	Standard Procedure n=20 Participants Routine protocol outpatient hysteroscopy
Anxiety Scores	3.33 score on a scale Standard Deviation 2.03	5.45 score on a scale Standard Deviation 3.35

Adverse Events

Virtual Reality

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Procedure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ms Nandita Deo

Imperial College London

Phone: 07939360357

Email: nandita.deo@gmail.com

Results disclosure agreements

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