Virtual Reality During Ultrasound Examination of Women With Endometriosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-14

Study Completion Date

2023-12-01

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.

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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.

Conditions

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Chronic Pain Pelvic Pain Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Virtual reality

women allocated to undergo ultrasound for the diagnosis of endometriosis with Virtual reality System

Group Type EXPERIMENTAL

SootheVR: AppliedVR, Los Angeles, California a head-mounted displa

Intervention Type DEVICE

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".

Standart care

women allocated to undergo ultrasound for the diagnosis of endometriosis without VR

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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".

Intervention Type DEVICE