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

NCT07267741 | Not Yet Recruiting

• 1 other identifier: Nrs.September2025/6
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depression; Anxiety; Stress

Keywords

Virtual Reality Technology; Depression; Anxiety; Stress; Breast Biopsy; Palestinian Patients

Outcome Measures

Primary Outcomes (1)

• Depression Anxiety Stress Scale-21 (DASS21)

  (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

Study Arms (2)

VR group

EXPERIMENTAL

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

control group

NO INTERVENTION

Participants will receive only standard care according to the hospital protocol during the procedure.

Interventions

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.

VR group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nablus University for Vocational and Technical Education: lead

Related Links

• the website Guided Meditation VR application, developed by Cubicle Ninjas Agency

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

khulud Mansor, PhD

CONTACT

00972599102693; Khulood.Mansour@nu-vte.edu.ps

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants in the VR group will wear a VR headset, while the control group will receive standard care without VR. The intervention involves a VR application featuring immersive 360-degree natural environments, including peaceful forests, tranquil beaches, and serene gardens. Patients can choose one environment, enhanced by relaxing music and nature sounds. VR sessions will last 15 to 30 minutes, with the headset used to immerse patients in their selected calming environment. The session will be terminated if the patient experiences discomfort or requests removal.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: December 10, 2025
• Primary Completion: January 10, 2026
• Study Completion: February 10, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share