Effect of Virtual Reality on Anxiety, Stress, Pain and Patient's Satisfaction Among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
The goal of this randomized controlled trial was to investigate the effect of Virtual Reality (VR) on anxiety, stress, pain, and patient satisfaction among Palestinian patients undergoing colonoscopy. The study aimed to determine the efficacy of VR as a non-pharmacological intervention to improve the patient experience during the procedure.
The main research hypotheses are:
H01: There will be no significant difference in anxiety levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
H02: There will be no significant difference in perceived stress levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
H03: There will be no significant difference in pain levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
H04: There will be no significant difference in satisfaction levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
Participants will:
Receive either a VR intervention or standard care during their colonoscopy. Wear a VR headset for 15-30 minutes, immersing themselves in a natural environment with relaxing music and nature sounds.
Complete assessments of anxiety, stress, pain, and satisfaction before and after the procedure using validated questionnaires.
详细描述
Title: Effect of Virtual Reality on Anxiety, Stress, Pain, and Patient Satisfaction among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial
Background: Colonoscopy is a common diagnostic and therapeutic procedure for gastrointestinal disorders but often causes anxiety, stress, and pain, which can complicate the procedure and increase sedative use. Virtual reality (VR) technology offers immersive, multi-sensory environments that may reduce these negative psychological and physical responses. This study aims to evaluate the effect of VR on anxiety, stress, pain, and patient satisfaction among Palestinian patients undergoing colonoscopy.
Methods: A randomized controlled trial will be conducted at the Endoscopy Unit of Rafidia Surgical Hospital in Nablus, Palestine. A total of 150 patients scheduled for colonoscopy will be randomly assigned to either the VR group (n=75) or the control group (n=75). The VR group will wear head-mounted VR devices for 15 to 30 minutes during the procedure, choosing from natural environments such as tropical beaches, forests, or snowy landscapes accompanied by relaxing music and nature sounds. Data on anxiety, stress, pain, and satisfaction will be collected through questionnaires administered by the researcher. The study duration is three 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective colonoscopy
- •Patients older than 18 years
- •Patients with no history of previous colonoscopy procedures
- •Patients experiencing moderate to severe anxiety and stress
排除标准
- •Patients who have a history of psychiatric disorders, epilepsy, hypertension, or chronic pain.
- •Patients who are mute and could not read, or write, patients with visual, hearing, or cognitive impairment.
- •Patients who implanted hearing aids or cardiac pacemakers.
- •Patients who were given any anxiolytic, sedative, or hypnotic drugs before or during procedure.
- •Patients who were exposed to complications during the operation.
结局指标
主要结局
State-Trait Anxiety Inventory (STAI)
时间窗: before colonoscopy and then 60 minutes post-procedure
The STAI score ranges between 20-80, the higher score indicating greater anxiety. It is classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80)
Perceived Stress Scale (PSS-10)
时间窗: before colonoscopy and then 60 minutes post-procedure
The PSS-10 score can range from 0 to 40 with higher scores indicating higher perceived stress. It is classified as "no or low anxiety" (0-13), "moderate anxiety" (14-26), and "high anxiety" (27-40).
次要结局
未报告次要终点
研究者
khulud "Mohammad Hasham" Hasham Mansor
Principal Investigator
Cairo University