DepressionVR/RCTNCT07267741
Using Virtual Reality Technology on Depression, Anxiety, and Stress Among Palestinian Patients Undergoing Breast Biopsy
A study testing Meta Quest 2 VR headset in people with Depression and Anxiety, run by Nablus University for Vocational and Technical Education.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- Meta Quest 2 VR headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Depression, Anxiety, Stress
- Being tested
- Meta Quest 2 VR headset
- Keywords
- Virtual Reality Technology, Depression, Anxiety, Stress, Breast Biopsy, Palestinian Patients
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meta Quest 2 VR headsetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Meta Quest 2 VR headset |
| control group | No intervention | Participants will receive only standard care according to the hospital protocol during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before the procedure and then 60 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion10 Jan 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nablus University for Vocational and Technical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khulood Mansour, Nablus University for Vocational and Technical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267741
- Sponsor's protocol ID
- Nrs.September2025/6
- Acronym
- VR/RCT
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Using Virtual Reality Technology on Depression, Anxiety, and Stress Among Palestinian Patients Undergoing Breast Biopsy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07267741
- Acronym / sponsor ID
- VR/RCT / Nrs.September2025/6
- Conditions
- Depression, Anxiety, Stress
- Keywords
- Virtual Reality Technology, Depression, Anxiety, Stress, Breast Biopsy, Palestinian Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nablus University for Vocational and Technical EducationUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 10 Jan 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: Meta Quest 2 VR headsetThe 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. |
| control group | No intervention | –Participants will receive only standard care according to the hospital protocol during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meta Quest 2 VR headsetThe 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. | Device | VR group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- the website Guided Meditation VR application, developed by Cubicle Ninjas AgencyLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Meta Quest 2 VR headset in people with Depression and Anxiety, run by Nablus University for Vocational and Technical Education.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact khulud Mansor, PhD (00972599102693, Khulood.Mansour@nu-vte.edu.ps), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety Stress Scale-21 (DASS21) (time frame: before the procedure and then 60 minutes post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.