- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07493499
Virtual Reality for Postoperative Recovery After Major Abdominal Surgery (VR-RECOVER)
Effect of Virtual Reality on Quality of Recovery and Hospital Stay After Major Abdominal Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
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:
A prospective, two-arm, single-blind randomized controlled trial conducted in the Department of General Surgery at a main university hospital operating under an established ERAS protocol. Sixty adult patients scheduled for elective major abdominal surgery are randomly allocated using computer-generated block randomization stratified by surgery type into two equal groups of 30 patients each.
Intervention:
Patients in the VR intervention group receive standard ERAS perioperative care supplemented by immersive VR sessions. One familiarization session of 15 minutes is administered on the evening before surgery, followed by session daily on Postoperative Days 1 through 3, each lasting 15 to 20 minutes, for a total VR exposure of approximately 90 to 120 minutes per patient. VR content includes nature immersion simulations, guided relaxation environments, breathing exercises, and mindfulness-based stress reduction modules.
Control:
Patients in the control group receive standard ERAS perioperative care only, without any VR exposure or distraction therapy.
Blinding:
The outcome assessor responsible for administering all assessment tools is independent from the clinical team and unaware of group allocation. Patients cannot be blinded to group assignment due to the nature of the VR intervention.
Outcome Assessment:
The primary outcome is the QoR-15 score at Postoperative Day 3 and length of hospital stay. Secondary outcomes include , daily pain scores using the Numeric Rating Scale, total opioid consumption in Morphine Milligram Equivalents, and clinical recovery milestones collected from the medical record. VR tolerability is monitored after each session using an adapted Simulator Sickness Questionnaire.
Sample Size:
A sample size of 60 patients (30 per group) was determined based on a power analysis assuming
Statistical Analysis:
Data will be analyzed using SPSS. Continuous variables will be compared using Independent t-test or Mann-Whitney U test. Categorical variables will be analyzed using Chi-square or Fisher's exact test. Serial QoR-15 scores will be analyzed using Mixed-Model ANOVA with group, time, and group-by-time interaction as factors. Baseline differences will be adjusted using ANCOVA. Effect sizes will be reported as Cohen's d. A p-value of less than 0.05 will be considered statistically significant.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed Fakhry Ahmed Salem Dr. Mohamed Fakhry Ahmed Salem, PhD
- Phone Number: +201286038014
- Email: Mohamed.Fakhry@alexu.edu.eg
Study Locations
-
-
Alexandria Governorate
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Alexandria, Alexandria Governorate, Egypt, 21511
- Recruiting
- Alexandria University Hospital, Faculty of Nursing
-
Principal Investigator:
- Mohamed Fakhry Ahmed Salem, PhD in Medical-Surgical Nursin
-
Contact:
- Mohamed Fakhry Ahmed Salem, PhD Medical-Surgical Nursing
- Phone Number: 01286038014
- Email: Mohamed.Fakhry@alexu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR Intervention Group
Patients in this group will receive standard perioperative care based on the Enhanced Recovery After Surgery (ERAS) protocol, supplemented by immersive Virtual Reality (VR) sessions.
Sessions focus on pain distraction, guided relaxation, and mindfulness-based stress reduction to alleviate postoperative pain and anxiety.
|
Session Protocol:
VR Content:
Safety Measures:
|
|
Active Comparator: 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.
|
Preoperative Phase:
Intraoperative Phase:
Postoperative Phase:
No Virtual Reality sessions or any form of distraction therapy will be provided to this group. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Postoperative Recovery (QoR-15)
Time Frame: Time Frame: Baseline (day before surgery), Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, and at hospital discharge.
|
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, Postoperative Day 2, Postoperative Day 3, and at hospital discharge.
|
|
Length of Hospital Stay (LOS)
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: From date of surgery until hospital discharge (up to 30 days).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity (NRS)
Time Frame: Time Frame: Daily from Postoperative Day 1 until hospital discharge, and before and after each VR session.
|
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: Daily from Postoperative Day 1 until hospital discharge, and before and after each VR session.
|
|
Total Opioid Consumption
Time Frame: Time Frame: Daily from Postoperative Day 0 until hospital discharge.
|
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: Daily from Postoperative Day 0 until hospital discharge.
|
|
Clinical Recovery Milestones
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).
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Time Frame: Recorded once at hospital discharge.
|
|
VR-Related Adverse Effects Simulator Sickness Questionnaire
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 after each VR session from the evening before surgery through Postoperative Day 3.
|
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Postoperative Anxiety
Time Frame: Immediately before and after each VR session during the first 48 postoperative hours
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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).
|
Immediately before and after each VR session during the first 48 postoperative hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU-20-10-457
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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