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NCT Number: NCT07267741

Using Virtual Reality Technology on Depression, Anxiety, and Stress Among Palestinian Patients Undergoing Breast Biopsy

The goal of this randomized controlled trial was to investigate the impact of Virtual Reality (VR) technology on depression, anxiety, and stress levels among Palestinian patients undergoing breast biopsy. The study aimed to evaluate the effectiveness of VR as a non-pharmacological intervention to reduce psychological distress associated with the biopsy procedure.

The main research hypotheses are:

H01: There will be no significant difference in depression levels between patients who receive immersive VR during breast biopsy and those who receive standard care.

H02: There will be no significant difference in anxiety levels between patients who receive immersive VR during breast biopsy and those who receive standard care.

H03: There will be no significant difference in stress levels between patients who receive immersive VR during breast biopsy and those who receive standard care.

Participants will:

Receive either a VR intervention or standard care during their breast biopsy. Wear a VR headset for 15-30 minutes, experiencing a calming virtual environment designed to promote relaxation.

Complete assessments of depression, anxiety, and stress before and after the procedure using validated psychological questionnaires.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Stress

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Title: The Impact of Using Virtual Reality Technology on Depression, Anxiety, and Stress Among Palestinian Patients Undergoing Breast Biopsy: A Randomized Controlled Trial

Background:

Breast biopsy is an essential diagnostic procedure for detecting breast abnormalities but often induces significant psychological distress, including depression, anxiety, and stress, which can negatively affect patient wellbeing and procedure outcomes. Virtual Reality (VR) technology provides immersive and calming environments that may help alleviate these emotional burdens without pharmacological intervention. This study aims to assess the effectiveness of VR in reducing depression, anxiety, and stress among Palestinian patients undergoing breast biopsy.

Methods:

A randomized controlled trial will be conducted at a healthcare facility in Palestine, enrolling a total of 80 patients scheduled for breast biopsy. Participants will be randomly assigned to either the VR intervention group (n=40) or the control group receiving standard care (n=40). The VR group will wear a head-mounted VR device for 15 to 30 minutes during the biopsy, immersing themselves in soothing virtual environments such as peaceful natural landscapes with accompanying relaxing music and nature sounds. Psychological assessments measuring depression, anxiety, and stress levels will be administered before and after the procedure using validated questionnaires. The data collection and intervention period will span approximately two months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Female patients scheduled to undergo a breast biopsy.
Patients older than 18 years.
Patients who are able to provide informed consent.
Patients with no prior history of severe psychiatric disorders that could affect the assessment of depression, anxiety, or stress.
Patients who are willing and able to participate in the VR intervention and complete self-report questionnaires.

Exclusion criteria

Patients who have a history of severe psychiatric disorders, epilepsy, hypertension, or chronic pain.
Patients who are mute and cannot read or write, patients with visual, hearing, or cognitive impairment.
Patients who have implanted hearing aids or cardiac pacemakers.
Patients who will receive any anxiolytic, sedative, or hypnotic drugs before or during the procedure.
Patients who may be exposed to complications during the procedure.

Treatment and study plan

Meta Quest 2 VR headset

Device

The VR intervention will utilize a head-mounted VR headset with built-in headphones. Patients will be selected for VR environments from a predefined list of natural scenes, including a tropical beach, diving, forest, and snowy landscape, each accompanied by relaxing music and nature sounds. The Guided Meditation VR application from Cubicle Ninjas (https://guidedmeditationvr.com/) provides 360-degree immersive nature environments with standardized calming background audio. VR will be applied during the procedure, with sessions lasting 15 to 30 minutes and discontinued if the patient experiences nausea, dizziness, or requests removal.

Primary outcomes

Depression Anxiety Stress Scale-21 (DASS21)

Time frame: before the procedure and then 60 minutes post-procedure

(DASS21) consists of 21 statements designed to measure symptoms of depression, anxiety, and stress experienced over the past week. Each statement is rated on a 4-point scale from 0 to 3.

Study contacts

Contact information is provided by the study sponsor or research team.

khulud Mansor, PhD

CONTACT

[email protected]

00972599102693

Sponsors and collaborators

Lead sponsor

Nablus University for Vocational and Technical Education

Other

Registry information

Official study title

The Impact of Using Virtual Reality Technology on Depression, Anxiety, and Stress Among Palestinian Patients Undergoing Breast Biopsy: Randomized Controlled Trial

Acronym: VR/RCT

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Dec 5, 2025
Registry last updated: Dec 5, 2025

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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