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Clinical Trials/NCT04711408
NCT04711408
Unknown
Not Applicable

Virtual Reality During Ultrasound Examination of Women With Endometriosis

Tel-Aviv Sourasky Medical Center1 site in 1 country100 target enrollmentJune 14, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
100
Locations
1
Primary Endpoint
Assessments of pain through pain score parameter
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 14, 2022
End Date
December 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Assessments of pain through pain score parameter

Time Frame: 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

Time Frame: 10 minutes

Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using Heart Rate-beats per minute.

Study Sites (1)

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