Alexandria University Hospital, Faculty of Nursing
Alexandria, Alexandria Governorate, 21511, Egypt
NCT Number: NCT07493499
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Alexandria, Alexandria Governorate, 21511, Egypt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Session Protocol:
VR Content:
Safety Measures:
Preoperative Phase:
Intraoperative Phase:
Postoperative Phase:
No Virtual Reality sessions or any form of distraction therapy will be provided to this group.
Time frame: 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
Time frame: 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.
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: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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
Alexandria University
Other
Effect of Adaptive AI-based Virtual Reality on Quality of Recovery and Hospital Stay After Major Abdominal Surgery
Acronym: VR-RECOVER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06895382
Abdominal Surgery, Anesthesia, Local
Tekirdağ, Turkey (Türkiye)
View Trial DetailsNCT01052012
Abdominal Surgery, Neurologic Manifestations
Birmingham, Alabama, United States
View Trial DetailsNCT07331441
Abdominal Surgery, Agnosia
Shanghai, China
View Trial DetailsNCT06448299
Abdominal Surgery, Disease Attributes
Cairo, Egypt
View Trial Details