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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR Intervention Group | Experimental | 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immersive Virtual Reality (VR) | Device | Session Protocol:
VR Content:
Safety Measures:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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, Postoperative Day 2, Postoperative Day 3, and at hospital discharge. |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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: Daily from Postoperative Day 1 until hospital discharge, and before and after each VR session. |
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Inclusion Criteria:
Exclusion Criteria:
- Patients with a history of epilepsy or photosensitive seizures.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Fakhry Ahmed Salem Dr. Mohamed Fakhry Ahmed Salem, PhD | Contact | +201286038014 | Mohamed.Fakhry@alexu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University Hospital, Faculty of Nursing | Recruiting | Alexandria | Alexandria Governorate | 21511 | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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A prospective, two-arm, randomized controlled trial. Participants are randomly assigned to either the VR intervention group (standard Enhanced Recovery After Surgery care + VR sessions) or the control group (standard Enhanced Recovery After Surgery care only).
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The outcome assessor responsible for administering all assessment tools is independent from the clinical team and unaware of group allocation to minimize detection bias.
|
| Standard Perioperative Care and Enhanced Recovery Protocol | Other | Preoperative Phase:
Intraoperative Phase:
Postoperative Phase:
No Virtual Reality sessions or any form of distraction therapy will be provided to this group. |
|
| 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: Daily from Postoperative Day 0 until hospital discharge. |
| 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: Recorded once at hospital discharge. |
| 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: Immediately after each VR session from the evening before surgery through Postoperative Day 3. |
| Postoperative Anxiety | 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |