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NCT Number: NCT07493499

Virtual Reality for Postoperative Recovery After Major Abdominal Surgery

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University Hospital, Faculty of Nursing

Alexandria, Alexandria Governorate, 21511, Egypt

Location status: Recruiting

Location contact

Mohamed Fakhry Ahmed Salem, PhD Medical-Surgical Nursing

CONTACT

[email protected]

01286038014

Mohamed Fakhry Ahmed Salem, PhD in Medical-Surgical Nursin

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immersive Virtual Reality (VR)

Device

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.

Standard Perioperative Care and Enhanced Recovery Protocol

Other

Preoperative 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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. Postoperative Anxiety

    Time frame: Immediately before and after each VR session during the first 48 postoperative hours

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Fakhry Ahmed Salem Dr. Mohamed Fakhry Ahmed Salem, PhD

CONTACT

[email protected]

+201286038014

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: VR-RECOVER

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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.

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