Virtual Reality for Anxiety and Pain Management in Transvaginal Ultrasound for Endometriosis (VR Endo TVU)

Sheba Medical Center

Status: Completed

Conditions: Endometriosis

Treatments: Behavioral: Virtual reality - based distraction

Study type: Interventional

Funder types: Other

Identifiers

NCT07328061

0142-23-SMC

Details and patient eligibility

About

The goal of this study to evaluate whether virtual reality (VR)-based technology, designed to promote relaxation and support pain self-management, can reduce anxiety and pain during trans-vaginal ultrasound (TVUS) for endometriosis.

Participants, women undergoing TVUS for endometriosis will be randomly assigned to either VR distraction group (VR-TVUS) or a standard examination group (control).

Anxiety and pain levels will be assessed immediately before and after the TVUS.

Enrollment: 155 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18 to 50 years.
• Confirmed or suspected diagnosis of endometriosis.
• Scheduled to undergo transvaginal ultrasound examination.
• Ability to understand the study procedures and independently complete study questionnaires.
• Provided written informed consent.

Exclusion criteria

• History of epilepsy or seizure disorders.
• History of migraines.
• Visual or hearing impairment.
• Diagnosed anxiety disorders.
• Claustrophobia.
• Current symptoms of dizziness or nausea.
• Active respiratory tract infection.
• Any contraindication to transvaginal ultrasound examination.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 2 patient groups

VR- TVUS Group

Experimental group

Description:

Participants undergo TVUS while using immersive virtual reality distraction

Treatment:

Behavioral: Virtual reality - based distraction

Contro Group - Standard TVUS

No Intervention group

Description:

Participants undergo standard TVUS, without virtual reality or any additional distraction intervention.