Effect of Adaptive AI-based Virtual Reality on Quality of Recovery and Hospital Stay After Major Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Length of Hospital Stay (LOS)
研究概览
简要总结
Major abdominal surgery is frequently associated with postoperative pain, anxiety, delayed recovery, and prolonged hospitalization. This study aims to evaluate the effectiveness of an AI-personalized virtual reality (VR) intervention as an adjunct to routine postoperative care in improving recovery outcomes among patients undergoing major abdominal surgery.
Participants assigned to the intervention group receive immersive VR sessions delivered through a smartphone-based head-mounted display integrated with an AI-assisted personalization system. The system combines patient-reported pain and anxiety levels, postoperative recovery status, emotional state estimates obtained through facial emotion recognition technology, and previous session feedback to personalize VR content and enhance patient engagement.
VR sessions are initiated on the first postoperative day and administered twice daily until hospital discharge. The primary outcome is postoperative quality of recovery measured using the Quality of Recovery-15 (QoR-15) questionnaire. Secondary outcomes include pain intensity, anxiety, recovery milestones, opioid requirements, simulator sickness, and length of hospital stay.
The study compares AI-personalized VR plus routine postoperative care with routine postoperative care alone. Findings from this trial will help determine whether AI-enhanced VR is a feasible, safe, and effective strategy for improving postoperative recovery and reducing hospital stay following major abdominal surgery.
详细描述
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:
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor responsible for administering all assessment tools is independent from the clinical team and unaware of group allocation to minimize detection bias.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •- 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.
研究组 & 干预措施
Control Group
Patients in this group will receive only the standard perioperative care according to the established Enhanced Recovery After Surgery (ERAS) protocol, without any VR exposure or distraction therapy.
干预措施: Standard Perioperative Care and Enhanced Recovery Protocol (Other)
AI-Personalized Virtual Reality (VR) Group
Participants received routine postoperative care plus an AI-personalized virtual reality intervention delivered through a smartphone-based head-mounted display. The intervention used facial emotion recognition, pain and anxiety assessments, postoperative status, and previous session feedback to personalize VR content. Sessions were administered twice daily from postoperative day 1 until hospital discharge.
干预措施: Immersive Virtual Reality (VR) (Device)
结局指标
主要结局
Length of Hospital Stay (LOS)
时间窗: Time Frame: From date of surgery until hospital discharge (up to 30 days).
The total number of days from the date of surgery until the patient meets standardized clinical discharge criteria based on the Enhanced Recovery After Surgery protocol, including tolerance of oral intake, adequate pain control on oral analgesia, independent mobilization, and absence of surgical complications.
Quality of Postoperative Recovery (QoR-15)
时间窗: Time Frame: Baseline (day before surgery), postoperative day 1 (POD1), postoperative day 3 (POD3), at hospital discharge, and on postoperative day 7 follow-up.
Description: A validated 15-item patient-reported outcome measure assessing five dimensions of postoperative recovery: pain, physical comfort, emotional state, psychological support, and functional independence. Each item is scored from 0 to 10, with a total score ranging from 0 (poorest recovery) to 150 (excellent recovery). A minimum clinically important difference of 8 points between groups is considered significant
次要结局
- Clinical Recovery Milestones(Time Frame: Recorded once at hospital discharge.)
- VR-Related Adverse Effects Simulator Sickness Questionnaire(Time Frame: Immediately after each VR session from the evening before surgery through Postoperative Day 3.)
- Postoperative Pain Intensity (NRS)(Baseline (day before surgery), postoperative day 1 (POD1), postoperative day 3 (POD3), at hospital discharge, and on postoperative day 7 follow-up.)
- Postoperative Anxiety(Immediately before and after each VR session Baseline (day before surgery), postoperative day 1 (POD1), postoperative day 3 (POD3), at hospital discharge, and on postoperative day 7 follow-up.)
- qualitative strand(at the end of the intervention)
研究者
Mohamed Fakhry Ahmed Salem
Lecturer of Medical-Surgical Nursing
Alexandria University