Virtual Reality During Ultrasound Examination of Women With Endometriosis

Tel Aviv Sourasky Medical Center

Status: Enrolling

Conditions: Pelvic Pain; Endometriosis; Chronic Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04711408

0602-20-TLV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Virtual reality

Experimental group

Description:

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

Treatment:

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

Standart care

No Intervention group

Description:

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