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

Pain and Hysteroscopy Clinical Trial

— VR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802460
• Other study ID #: STUDY00001687
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: March 2021
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2, 2021
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain and Hysteroscopy

Intervention

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.

Locations

Country	Name	City	State
United States	MHRI IRB	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain scale	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).	10 minutes
Secondary	heart rate changes	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.	10 minutes