Effect of Virtual Reality on Patient Outcomes and Satisfaction in Total Knee Replacement

Официальное название

The Effect of Virtual Reality Applications on Patient Outcomes and Satisfaction Before and After Total Knee Replacement: A Randomised Controlled Study

Обзор

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.

Вмешательства

• Устройство Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours)
  The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 2 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 min
• Устройство Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours)
  The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 4 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 min
• Устройство Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours)
  The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 6 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 min

Первичные конечные точки

• 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. [Срок оценки: 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]

Вторичные конечные точки (8)

• Preoperative Anxiety Measured Using the State-Trait Anxiety Inventory-State (STAI-S) Scale [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Postoperative, Day 1]
• Change in Body Temperature (Celsius) from Baseline [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Aibu Izzet Baysal Training and Research Hospital — Bolu

Идентификаторы

NCT: NCT06933732 · AIBU-SBF-AT-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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