Using Virtual Reality Technology on Depression, Anxiety, and Stress Among Palestinian Patients Undergoing Breast Biopsy (VR/RCT)

November 25, 2025 updated by: Khulood Mansour, Nablus University for Vocational and Technical Education

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • 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 Contact

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR group
The VR group 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. VR will be applied during the procedure, with sessions lasting 15 to 30 minutes.
Device: Meta Quest 2 VR headset
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.
No Intervention: control group
Participants will receive only standard care according to the hospital protocol during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before the procedure and then 60 minutes post-procedure

Collaborators and Investigators

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

Sponsor

Nablus University for Vocational and Technical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Estimated)

December 10, 2025

Primary Completion (Estimated)

January 10, 2026

Study Completion (Estimated)

February 10, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nrs.September2025/6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data (IPD) cannot be shared due to ethical concerns about participant privacy and the inappropriate use of data. Also, compliance with journal publication policies

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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