Virtual Reality During Ultrasound Examination of Women With Endometriosis

Not Applicable

• Conditions: Pelvic Pain; Endometriosis; Chronic Pain

• Registration Number: NCT04711408
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-03
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-15
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Study Start: 2022-06-14
• Last Update Posted: 2022-06-14
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• patient needed ultrasound with the diagnosis of endometriosis. the diagnosis of endometriosis is based on ultrasound finding or previous surgery.

Exclusion Criteria

• women who reported the use of analgesia 6 hours prior to the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessments of pain through pain score parameter	20 minutes	Assessments of pain through pain score parameter of the NRS questionnaire. Pain will be measured using the Numeric Rating Scale (NRS) which is a 11 point scale from 0 to 10 which is a validated score of measuring pain and anxiety in which 0 is no pain and 10 is the worst imaginable pain and or anxiety.
Assessments of pain through physiological parameters	10 minutes	Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using Heart Rate-beats per minute.

Trial Locations

Locations (1)

Lis Maternity Hospital, Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel