The Impact of Using Virtual Reality Technology on Depression, Anxiety, and Stress Among Palestinian Patients Undergoing Breast Biopsy: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Depression Anxiety Stress Scale-21 (DASS21)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Depression Anxiety Stress Scale-21 (DASS21)
时间窗: 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.
次要结局
未报告次要终点
研究者
Khulood Mansour
Principal Investigator
Nablus University for Vocational and Technical Education