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

December 28, 2025 updated by: Michal Zajicek, Sheba Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From immediately before the TVUS to immediately after completion of the examination.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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").
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
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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