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

NCT07328061 | Completed

• 1 other identifier: 0142-23-SMC
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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

Keywords

Virtual reality; VR distraction; Transvaginal Ultrasound; TVUS; Anxiety; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in pain intensity measured by Visual Analog scale (VAS)

  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

  The outcome measure is the change in the heart rate and blood pressure from immediately before to immediately after the TVUS examination.

Study Arms (2)

VR- TVUS Group

EXPERIMENTAL

Participants undergo TVUS while using immersive virtual reality distraction

Behavioral: Virtual reality - based distraction

Contro Group - Standard TVUS

NO INTERVENTION

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

Interventions

Virtual reality - based distraction 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

VR- TVUS Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Endometriosis Center, Sheba Medical Center

Ramat Gan, Central District, Israel

Location

MeSH Terms

Conditions

Endometriosis; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants Are randomized to undergo either transvaginal ultrasound with virtual reality distraction or standard transvaginal ultrasound without virtual reality. Each participant is assigned to a single study arm for the duration of the study.

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 8, 2026
• Study Start: December 10, 2023
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)