The Effect of Virtual Reality Applications on Patient Outcomes and Satisfaction Before and After Total Knee Replacement: A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from Baseline in Postoperative Pain Intensity as Measured by Visual Analogue Scale (VAS) at 2, 4, and 6 Hours After Surgery in Patients Receiving Virtual Reality Interventions.
研究概览
简要总结
This study aims to evaluate the effectiveness of virtual reality (VR) in managing preoperative anxiety and postoperative pain in patients undergoing total knee replacement. Investigators will assess the impact of preoperative VR training on anxiety levels, explore the effectiveness of relaxing and distracting VR videos for pain management after surgery, and determine the optimal timing for VR application by comparing different VR intervention times. Our goal is to identify how VR can improve both the emotional and physical recovery process for patients undergoing knee replacement 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an ASA score of 1, 2, or 3
- •Elective unilateral total knee replacement surgery was planned,
- •Patients who are able to read and write in Turkish
排除标准
- •Using >30 mg of oral oxycodone or equivalent daily
- •Long-term opioid use (>12 weeks)
- •Substance use disorder
- •Scheduled for emergency surgery
- •Scheduled for revision surgery
- •Requiring postoperative intensive care
- •Patients with visual or hearing impairments
- •Individuals experiencing motion-related nausea or dizziness
- •History of stroke or dementia
- •Pregnant or breastfeeding women
- •Patients with a history of epilepsy or seizures
研究组 & 干预措施
Control Group
Participants in this group will receive standard care, which includes preoperative education about the surgical process via an educational video and the completion of informed consent. No virtual reality intervention will be provided during their recovery.
2-Hour Postoperative VR Intervention
Participants in this group will first watch an educational VR video about the surgery before the procedure. Two hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos.
干预措施: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours) (Device)
4-Hour Postoperative VR Intervention
Participants in this group will first watch an educational VR video about the surgery before the procedure. Four hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos.
干预措施: Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours) (Device)
6-Hour Postoperative VR Intervention
Participants in this group will first watch an educational VR video about the surgery before the procedure. Six hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos.
干预措施: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours) (Device)
结局指标
主要结局
Change from Baseline in Postoperative Pain Intensity as Measured by Visual Analogue Scale (VAS) at 2, 4, and 6 Hours After Surgery in Patients Receiving Virtual Reality Interventions.
时间窗: Baseline (before VR intervention) and assessments at 2, 4, and 6 hours after surgery, with a 15-Minute wait after VR video completion before each pain assessment
0 = No pain 10 = Worst pain possible
次要结局
- Preoperative Anxiety Measured Using the State-Trait Anxiety Inventory-State (STAI-S) Scale(Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1))
- Change from Baseline in Virtual Reality Sickness as Measured by the Virtual Reality Sickness Questionnaire (VRSQ)(Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1))
- Patient Satisfaction as Measured by a 0-10 Numeric Rating Scale Post-Intervention(Postoperative, Day 1)
- Change in Body Temperature (Celsius) from Baseline(Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.)
- Change in Heart Rate/min from Baseline(Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.)
- Change in Blood Pressure from Baseline (Systolic/Diastolic mmHg)(Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.)
- Change in Respiratory Rate/min from Baseline(Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.)
- Change in Blood Oxygen Saturation(%) from Baseline(Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.)
研究者
Aykut Turgut
Research Assistant
Abant Izzet Baysal University