Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07493499

Virtual Reality for Postoperative Recovery After Major Abdominal Surgery

Effect of Virtual Reality on Quality of Recovery and Hospital Stay After Major Abdominal Surgery

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Alexandria University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
DEVICEImmersive Virtual Reality (VR)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.
OTHERStandard Perioperative Care and Enhanced Recovery ProtocolPreoperative 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.

Timeline

Start date
2026-03-28
Primary completion
2026-04-01
Completion
2026-05-01
First posted
2026-03-25
Last updated
2026-04-15

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07493499. Inclusion in this directory is not an endorsement.