Virtual Reality for Anxiety and Pain Management in Transvaginal Ultrasound for Endometriosis

NCT ID: NCT07328061

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-10
• Study Completion Date: 2024-08-20

Brief Summary

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR- TVUS Group

Participants undergo TVUS while using immersive virtual reality distraction

Group Type: EXPERIMENTAL

Virtual reality - based distraction

Intervention Type: BEHAVIORAL

Participants use an immersive virtual reality headset during TVUS. The intervention consists of immersive three-dimensional (3D) VR distraction delivered a head-mounted display, allowing participants to engage with a computer-simulated virtual environment, with or without guided audio based mindfulness relaxation techniques. The intervention is designed to reduce pain and anxiety during US examination. Each session lasts approximately 10-15 minutes, and may include calming music or guided meditation audio

Contro Group - Standard TVUS

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality - based distraction

Participants use an immersive virtual reality headset during TVUS. The intervention consists of immersive three-dimensional (3D) VR distraction delivered a head-mounted display, allowing participants to engage with a computer-simulated virtual environment, with or without guided audio based mindfulness relaxation techniques. The intervention is designed to reduce pain and anxiety during US examination. Each session lasts approximately 10-15 minutes, and may include calming music or guided meditation audio

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Michal Zajicek

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Endometriosis Center, Sheba Medical Center

Ramat Gan, Central District, Israel

Countries

Israel

Other Identifiers

0142-23-SMC

Identifier Type: -

Identifier Source: org_study_id