The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- State- Trait Anxiety Inventory 6 questionnaire
研究概览
简要总结
The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.
Participants in the intervention group will receive a 20 minute session with the head mounted VR device on post-operative days 1,2 and 3.
Participants in the control group will be treated with conventional post-operative care.
详细描述
Objective
The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.
Study design: This study is a single-center randomized control trial.
Study population: Patients who have undergone a CABG procedure (n=100).
Intervention: The intervention group (n=50) will use the VR distraction therapy device at day 1, 2 and 3 after surgery on the general ward. The control group (n=50) will be treated with conventional post-operative pain and anxiety management.
Main study parameters/endpoints: The main study parameters at day 1, 2 and 3 after surgery. These are the Numeric Rating Scale (NRS) to assess the effect of pain on mobility, the Quality of Recovery-15 questionnaire, the State-Trait Anxiety Inventory-6 questionnaire and assessment of analgesic use. At follow-up, participants will be called to gather one-time QoR-15 and STAI-6 questionnaire data 6 weeks after the surgery.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years or older with written informed consent
- •Patients undergoing surgical CABG
排除标准
- •Major comorbidities besides coronary artery disease
- •Complicated surgical procedure
- •Hearing and/or visual impairments
- •Psychiatric impairments
- •Complaints of vomiting and nausea
- •History of epilepsy
- •Claustrophobia
- •Facial wounds and skin defects at site of application
- •Patients placed in clinical isolation
- •Readmission to the intensive care unit
结局指标
主要结局
State- Trait Anxiety Inventory 6 questionnaire
时间窗: Post-operative days 1,2 and 3 directly after the VR intervention
The STAI-6 questionnaire is a validated psychological inventory designed to measure worry, tension and anxiety in an individual. It is a shortend version of the STAI score
Numeric Rating Scale (NRS)
时间窗: Post-operative days 1,2 and 3 directly after the VR intervention
The NRS score is a numeric scale in which individuals rate pain from 0 (no pain) tot 10 (worst pain). This is a subjective score which is assessed verbally and used frequently in standard clinical care in multiple medical specialties.
Quality of Recovery-15
时间窗: Post-operative days 1,2 and 3 directly after the VR intervention
The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery.
次要结局
未报告次要终点
研究者
Jolanda Kluin
Professor dr. J. Kluin, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)