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

Effect of Virtual Reality on Anxiety and Pain During Trans-vaginal Ultrasound for Endometriosis: A Prospective Randomized Controlled Study.

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Behavioral: Virtual reality - based distraction

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Central District
    • Ramat Gan, Central District, Israel
      • Endometriosis Center, Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR- TVUS Group; Participants undergo TVUS while using immersive virtual reality distraction	Behavioral: 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
No Intervention: Contro Group - Standard TVUS; Participants undergo standard TVUS, without virtual reality or any additional distraction intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety level measured by State Anxiety Inventory (STAI-S)Anxiety levels are assessed using the Stating	Anxiety levels are assessed using the State Anxiety Inventory (STAI-S). It includes 20 items such as "I feel calm " and "I am tense ". Participates were instructed to circle the number that best describes how they felt at that moment from 1 to 4 (from "Not at all" to "Very much so"). The STAI-S questionnaire is scored by summing the responses to the individual items and the possible scores ranges from 20 to 80, where 20-37 refers to "no or low anxiety", 38-44 to "moderate anxiety", and 45-80 to "high anxiety" (45-80). The outcome measure is the change in STAI-S score from before to immediately after the TVUS examination	From immediately before the TVUS to immediately after completion of the examination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity measured by Visual Analog scale (VAS)	Pain intensity is assessed using a VAS . VAS is a self-reported measure of pain expressed as a number on a continuum between 1 ("no pain") and 10 ("worst pain").	From immediately before the TVUS to immediately after completion of the examination.
Change in heart rate and blood pressure '(including mean arterial pressure) during TVUS	Heart rate and blood pressure level are measured as objective measures of emotional distress and pain.	The outcome measure is the change in the heart rate and blood pressure from immediately before to immediately after the TVUS examination.

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2023
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): August 20, 2024

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Transvaginal Ultrasound; Virtual reality; VR distraction; TVUS
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Mental Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Endometriosis
• Other Study ID Numbers: 0142-23-SMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No