Abdominal Surgery, Length of Hospital Stay, Postoperative Pain, Postoperative Recovery
Conditions
Keywords
Virtual Reality, VR Therapy, Distraction Therapy, ERAS (Enhanced Recovery After Surgery), Perioperative Care, Non-pharmacological Pain Management
Brief summary
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.
Interventions
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-related adverse effects monitored after each session using an adapted Simulator Sickness Questionnaire (SSQ). * Sessions are discontinued immediately if the patient reports Moderate or Severe symptoms. * All VR equipment is disinfected between uses according to hospital infection control protocols.
OTHERStandard 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 patients. Postoperative Phase: * Standardized multimodal pharmacological pain management. * Early mobilization encouraged within 6 hours after surgery. * Early oral nutrition initiated as soon as clinically appropriate. * Patient-controlled analgesia (PCA) available if indicated. No Virtual Reality sessions or any form of distraction therapy will be provided to this group.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor responsible for administering all assessment tools is independent from the clinical team and unaware of group allocation to minimize detection bias.
Intervention model description
A parallel-group, two-arm randomized controlled trial with an explanatory sequential mixed-methods design was conducted to evaluate the effect of an AI-personalized virtual reality (VR) intervention on postoperative recovery after major abdominal surgery. Participants were randomly assigned to either routine postoperative care alone or routine care plus AI-personalized VR. The intervention was delivered through a smartphone-based head-mounted display and incorporated a pre-trained facial emotion recognition model and a decision-support personalization engine. Before each session, pain, anxiety, postoperative status, demographic characteristics, emotional state estimates, and previous session feedback were used to personalize immersive VR content. Sessions began on postoperative day 1, were administered twice daily until discharge, and lasted approximately 15 minutes. Outcomes included quality of recovery (QoR-15), pain, anxiety, recovery milestones, opioid requirements, simulator sickn
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
\- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Postoperative Recovery (QoR-15) | 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 |
| Length of Hospital Stay (LOS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| qualitative strand | at the end of the intervention | using semi-structured interviews to evaluate and explain the trial results. In order to provide a comprehensive understanding of the intervention outcomes |
| VR-Related Adverse Effects Simulator Sickness Questionnaire | Time Frame: Immediately after each VR session from the evening before surgery through Postoperative Day 3. | Description: VR tolerability assessed after each session using an adapted version of the Simulator Sickness Questionnaire (Kennedy et al., 1993), modified to include the four most clinically relevant symptoms in the postoperative setting: nausea, dizziness, headache, and eye strain. Each symptom is rated on a four-point scale: None / Slight / Moderate / Severe. Sessions are discontinued if Moderate or Severe symptoms are reported. |
| Clinical Recovery Milestones | Time Frame: Recorded once at hospital discharge. | Description: Objective recovery indicators collected from the medical record including: time to first ambulation (hours after surgery), time to first liquid intake (hours after surgery), time to first soft diet intake (hours after surgery), and time to IV fluid discontinuation (hours after surgery). |
| 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. | Description: Pain intensity assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Scores are recorded daily from the nursing file and additionally before and after each VR session to capture the immediate analgesic effect of VR. |
| 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. | Postoperative anxiety will be assessed as a secondary exploratory outcome using a single-item Numeric Rating Scale for Anxiety (NRS-A). Patients will rate their current level of anxiety on a scale from 0 (no anxiety) to 10 (extreme anxiety). |
Countries
Egypt
Outcome results
None listed