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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain and Hysteroscopy
• Intervention / Treatment: Device: Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MHRI IRB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality; 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.	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.
No Intervention: control arm; Patients in the control arm will undergo standard of care office hysteroscopy. Both study groups will be directed to take 800mg ibuprofen 1 hour prior to scheduled surgery as standard pain management in our office.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): February 2, 2021

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00001687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No