About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Meta Quest 2 VR headset
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: