Virtual Reality for Postoperative Recovery After Major Abdominal Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Immersive Virtual Reality (VR), Standard Perioperative Care and Enhanced Recovery Protocol.
- Кому может быть актуально
- Состояния в реестре: Abdominal Surgery, Postoperative Recovery, Postoperative Pain, Length of Hospital Stay. Базовые параметры: 18 лет — 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
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Официальное название
Effect of Virtual Reality on Quality of Recovery and Hospital Stay After Major Abdominal Surgery
Обзор
Major abdominal surgery often leads to significant postoperative pain, anxiety, and prolonged hospital stays, which can delay overall recovery. This study aims to evaluate the effectiveness of immersive Virtual Reality (VR) as a non-pharmacological intervention to enhance the quality of recovery and reduce the length of hospital stay. Patients in the intervention group will engage in standardized VR sessions featuring guided relaxation and mindfulness-based stress reduction, starting from the evening before surgery through the third postoperative day. The study compares this VR-enhanced protocol against standard perioperative care within an Enhanced Recovery After Surgery (ERAS) framework. The findings are expected to determine if VR can serve as a feasible and effective tool to improve clinical outcomes and patient well-being in surgical wards.
Подробное описание
Background:
Major abdominal surgery is associated with significant postoperative pain, anxiety, and prolonged hospital stays. Despite advances in Enhanced Recovery After Surgery (ERAS) protocols, non-pharmacological adjuncts to pain management remain underutilized in surgical wards. Virtual Reality (VR) has emerged as a promising distraction-based intervention that may reduce pain perception, alleviate anxiety, and accelerate postoperative recovery without the adverse effects associated with pharmacological agents.
Objectives:
The primary objective of this study is to evaluate the effect of immersive VR sessions on the quality of postoperative recovery as measured by the QoR-15 scale at 72 hours after surgery. The secondary objectives are to assess the effect of VR on length of hospital stay, postoperative pain intensity, total opioid consumption, and clinical recovery milestones including time to first ambulation and first oral intake.
Study Design:
A prospective, two-arm, single-blind randomized controlled trial conducted in the Department of General Surgery at a main university hospital operating under an established ERAS protocol. Sixty adult patients scheduled for elective major abdominal surgery are randomly allocated using computer-generated block randomization stratified by surgery type into two equal groups of 30 patients each.
Intervention:
Patients in the VR intervention group receive standard ERAS perioperative care supplemented by immersive VR sessions. One familiarization session of 15 minutes is administered on the evening before surgery, followed by session daily on Postoperative Days 1 through 3, each lasting 15 to 20 minutes, for a total VR exposure of approximately 90 to 120 minutes per patient. VR content includes nature immersion simulations, guided relaxation environments, breathing exercises, and mindfulness-based stress reduction modules.
Control:
Patients in the control group receive standard ERAS perioperative care only, without any VR exposure or distraction therapy.
Blinding:
The outcome assessor responsible for administering all assessment tools is independent from the clinical team and unaware of group allocation. Patients cannot be blinded to group assignment due to the nature of the VR intervention.
Outcome Assessment:
The primary outcome is the QoR-15 score at Postoperative Day 3 and length of hospital stay. Secondary outcomes include , daily pain scores using the Numeric Rating Scale, total opioid consumption in Morphine Milligram Equivalents, and clinical recovery milestones collected from the medical record. VR tolerability is monitored after each session using an adapted Simulator Sickness Questionnaire.
Sample Size:
A sample size of 60 patients (30 per group) was determined based on a power analysis assuming
Statistical Analysis:
Data will be analyzed using SPSS. Continuous variables will be compared using Independent t-test or Mann-Whitney U test. Categorical variables will be analyzed using Chi-square or Fisher's exact test. Serial QoR-15 scores will be analyzed using Mixed-Model ANOVA with group, time, and group-by-time interaction as factors. Baseline differences will be adjusted using ANCOVA. Effect sizes will be reported as Cohen's d. A p-value of less than 0.05 will be considered statistically significant.
Вмешательства
- Устройство Immersive Virtual Reality (VR)
Session Protocol: * Preoperative session: One session of 15 minutes on the evening before surgery for familiarization with the VR equipment and content. * Postoperative sessions: daily on Postoperative Days 1, 2, and 3, each session lasting 15 to 20 minutes. * Total VR exposure: approximately 90 to 120 minutes per patient. VR Content: * Nature immersion simulations * Guided relaxation environments * Breathing exercises * Mindfulness-based stress reduction modules Safety Measures: * VR-relat - Другое Standard Perioperative Care and Enhanced Recovery Protocol
Preoperative Phase: * Patient education and counseling regarding the surgical procedure and postoperative recovery expectations. * Administration of carbohydrate-rich drinks before surgery to reduce metabolic stress. Intraoperative Phase: * Propofol-based total intravenous anaesthesia or balanced anaesthesia. * Opioid-sparing multimodal analgesia. * Optimized intraoperative fluid management. * Standardized neuromuscular blockade reversal. * Intraoperative opioid dosing recorded for all patien
Первичные конечные точки
- Quality of Postoperative Recovery (QoR-15) [Срок оценки: Time Frame: Baseline (day before surgery), Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, and at hospital discharge.]
- Length of Hospital Stay (LOS) [Срок оценки: Time Frame: From date of surgery until hospital discharge (up to 30 days).]
Вторичные конечные точки (5)
- Postoperative Pain Intensity (NRS) [Срок оценки: Time Frame: Daily from Postoperative Day 1 until hospital discharge, and before and after each VR session.]
- Total Opioid Consumption [Срок оценки: Time Frame: Daily from Postoperative Day 0 until hospital discharge.]
- Clinical Recovery Milestones [Срок оценки: Time Frame: Recorded once at hospital discharge.]
- VR-Related Adverse Effects Simulator Sickness Questionnaire [Срок оценки: Time Frame: Immediately after each VR session from the evening before surgery through Postoperative Day 3.]
- Postoperative Anxiety [Срок оценки: Immediately before and after each VR session during the first 48 postoperative hours]
Критерии участия
Критерии включения
- Adult patients aged 18 to 60 years.
- Scheduled for elective major abdominal surgery (e.g., colorectal, gastric, or hepatobiliary procedures).
- Physical and cognitive ability to provide informed consent.
- Ability to use and interact with Virtual Reality (VR) equipment (head-mounted display).
- Followed the standardized Enhanced Recovery After Surgery (ERAS) protocol at the hospital.
Критерии исключения
\- Patients with a history of epilepsy or photosensitive seizures.
- Significant cognitive impairment or diagnosed psychiatric disorders that may interfere with study participation.
- Severe visual or auditory impairments that prevent effective interaction with VR content.
- Patients with pre-existing motion sickness or severe vertigo.
- Presence of open wounds or infections in the head or face area that prevent wearing the VR headset.
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
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Египет · 1 центр
- Alexandria University Hospital, Faculty of Nursing — Alexandria
Идентификаторы
NCT: NCT07493499 · AU-20-10-457