NCT04625920

A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during operative hysteroscopy in the outpatient setting.

Detailed description

A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo operative hysteroscopy either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.

Conditions

• Infertility
• Vaginal Blood Loss

Interventions

Type	Name	Description
DEVICE	SootheVR: AppliedVR, Los Angeles, California	a head-mounted display

Timeline

• Start date: 2020-04-10
• Primary completion: 2020-09-20
• Completion: 2020-09-30
• First posted: 2020-11-12
• Last updated: 2020-11-12

Locations

2 sites across 1 country: Israel