Virtual Reality for Postoperative Recovery After Major Abdominal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAlexandria University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Immersive Virtual Reality (VR)
DeviceSession 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.
Standard Perioperative Care and Enhanced Recovery Protocol
Other interventionPreoperative 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: VR Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time Frame: Baseline (day before surgery), Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, and at hospital discharge.2
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
Time Frame: From date of surgery until hospital discharge (up to 30 days).Secondary outcomes
1
Postoperative Pain Intensity (NRS)
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: Daily from Postoperative Day 1 until hospital discharge, and before and after each VR session.2
Total Opioid Consumption
Description: Total opioid consumption recorded daily from the patient medication record, including all scheduled opioids and PRN analgesics. All opioids are converted to Morphine Milligram Equivalents to allow standardized comparison between groups.
Time frame
Time Frame: Daily from Postoperative Day 0 until hospital discharge.3
Clinical Recovery Milestones
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: Recorded once at hospital discharge.4
VR-Related Adverse Effects Simulator Sickness Questionnaire
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
Time Frame: Immediately after each VR session from the evening before surgery through Postoperative Day 3.Sponsors and contacts
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Source ClinicalTrials.gov