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

MedStar Health

Status: Completed

Conditions: Pain and Hysteroscopy

Treatments: Device: Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)

Study type: Interventional

Funder types: Other

Identifiers

NCT04802460

STUDY00001687

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

virtual reality

Experimental group

Description:

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.

Treatment:

Device: Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)

control arm

No Intervention group

Description:

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.