NCT04711408

Virtual Reality During Ultrasound Examination of Women With Endometriosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during ultrasound exam in patients with endometriosis 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 ultrasound exam 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

• Chronic Pain
• Pelvic Pain
• Endometriosis

Interventions

Type	Name	Description
DEVICE	SootheVR: AppliedVR, Los Angeles, California a head-mounted displa	For the study group, virtual reality content will be administered to the participant for the duration of the examination through a head-mounted display, RelieVRTM. The VR content for the trial will be "swimming with dolphins".

Timeline

• Start date: 2022-06-14
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2021-01-15
• Last updated: 2022-06-14

Locations

1 site across 1 country: Israel