Virtual Reality Effects on Pain During Hysteroscopy Hysteroscopy: A Randomized Control Trial

Not Applicable

Completed

• Conditions: Pain and Hysteroscopy
• Interventions: Device: Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)

• Registration Number: NCT04802460
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

The Objective of this study is to compare pain levels in women undergoing office-based hysteroscopies using Virtual Reality versus control in a randomized control prospective trial.

Detailed Description

The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).

A secondary aim will be to monitor heart rate for patients using virtual reality versus the controls during the procedure. Another secondary aim will be to time the length of the procedure as it is possible if pain perception is reduced, the procedure can be completed faster. Lastly, we would also want to evaluate both patient and surgeon satisfaction of the procedure with or without virtual reality by using a satisfaction questionnaire to assess for patients satisfaction with the procedure, with the VR intervention, perceived realism of VR game, and measure simulator sickness related to the VR game.

Study Timeline

• Study Start: 2020-05-01
• Primary Completion: 2020-11-20
• Study Completion: 2021-02-02
• Status Verified: 2021-03
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-16
• Last Update Submitted: 2021-03-16
• Study First Posted: 2021-03-17
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Inclusion criteria will be women over the age of 18 presenting for office hysteroscopy.

Exclusion Criteria

Exclusion criteria included patients with visual or auditory impairment that would interfere with their ability to use the virtual reality set, English language non-fluency, history of opioid dependence/abuse, current narcotic use, or desire for narcotic use during the procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
virtual reality	Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)	Patients assigned to the VR group will be engaged with the VR using a publicly available VR set. Both study groups will be directed to take 800mg ibuprofen 1 hour prior to scheduled surgery as standard pain management in our office.

Primary Outcome Measures

Name	Time	Method
pain scale	10 minutes	The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).

Secondary Outcome Measures

Name	Time	Method
heart rate changes	10 minutes	The secondary outcomes will be change in pain score and change in participant's HR throughout the procedure to assess for sympathetic evidence of pain and anxiety.

Trial Locations

Locations (1)

MHRI IRB; 🇺🇸 Washington, District of Columbia, United States