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Completed

NCT Number: NCT07328061

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Endometriosis Center, Sheba Medical Center

Ramat Gan, Central District, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change in anxiety level measured by State Anxiety Inventory (STAI-S)Anxiety levels are assessed using the Stating

    Time frame: From immediately before the TVUS to immediately after completion of the examination.

    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

Secondary outcomes

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

    Time frame: From immediately before the TVUS to immediately after completion of the examination.

    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").

  2. Change in heart rate and blood pressure '(including mean arterial pressure) during TVUS

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

    Heart rate and blood pressure level are measured as objective measures of emotional distress and pain.

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Acronym: VR Endo TVU

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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