NCT04802460

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

Virtual Reality Effects on Acute Pain During Office Hysteroscopy: A Randomized Control Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain and Hysteroscopy

Interventions

Type	Name	Description
DEVICE	Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)	Patients assigned to the VR condition will engage with the VR using The Guided Meditation VR App through Oculus Go headset. They will enjoy up to a 10 minute video of an environment of their choosing. During this video they will listen to calming music and a guided meditation session.

Timeline

• Start date: 2020-05-01
• Primary completion: 2020-11-20
• Completion: 2021-02-02
• First posted: 2021-03-17
• Last updated: 2021-03-17

Locations

1 site across 1 country: United States