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

Sheba Medical Center155 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

Endometriosis

Interventions

Virtual reality - based distractionBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Endometriosis Center, Sheba Medical Center

Ramat Gan, Central District, Israel

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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").

Time frame: 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.

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

Data from ClinicalTrials.gov

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