Effect of AI-Personalized Virtual Reality on Postoperative Recovery After Major Abdominal Surgery

NCT07493499 | Completed

• 1 other identifier: AU-20-10-457
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Recovery; Postoperative Pain; Length of Hospital Stay; Abdominal Surgery

Keywords

Virtual Reality; VR Therapy; Distraction Therapy; ERAS (Enhanced Recovery After Surgery); Perioperative Care; Non-pharmacological Pain Management

Outcome Measures

Primary Outcomes (2)

• Quality of Postoperative Recovery (QoR-15)

  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

  Time Frame: Baseline (day before surgery), postoperative day 1 (POD1), postoperative day 3 (POD3), at hospital discharge, and on postoperative day 7 follow-up.

• Length of Hospital Stay (LOS)

  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.

  Time Frame: From date of surgery until hospital discharge (up to 30 days).

Secondary Outcomes (5)

• 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.

• 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 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

Study Arms (2)

AI-Personalized Virtual Reality (VR) Group

EXPERIMENTAL

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.

Device: Immersive Virtual Reality (VR)

Control Group

ACTIVE COMPARATOR

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.

Other: Standard Perioperative Care and Enhanced Recovery Protocol

Interventions

Immersive Virtual Reality (VR) DEVICE

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.

AI-Personalized Virtual Reality (VR) Group

Standard Perioperative Care and Enhanced Recovery Protocol OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Hospital, Faculty of Nursing

Alexandria, Alexandria Governorate, 21511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor responsible for administering all assessment tools is independent from the clinical team and unaware of group allocation to minimize detection bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Medical-Surgical Nursing

Model Details: 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

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 25, 2026
• Study Start: March 28, 2026
• Primary Completion: May 10, 2026
• Study Completion: June 30, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)