Virtual Reality During Ultrasound Examination of Women With Endometriosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual Reality During Ultrasound Examination of Women With Endometriosis

Conditions
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Chronic Pain, Pelvic Pain, Endometriosis

Intervention / Treatment
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* Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted displa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>women allocated to undergo ultrasound for the diagnosis of endometriosis with Virtual reality System | Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted displa<br>* 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.<br>|
| No Intervention: Standart care<br>women allocated to undergo ultrasound for the diagnosis of endometriosis without VR | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessments of pain through pain score parameter | 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. | 20 minutes | 
| Assessments of pain through physiological parameters | Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using Heart Rate-beats per minute. | 10 minutes |