Clinical Trial

The Efficacy of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients

Study acronym: VR-MindPain
Not Yet Recruiting
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Record status
This record was last updated May 8, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this randomized clinical trial is to evaluate whether a virtual reality (VR) mindfulness intervention can reduce anxiety and postoperative pain in adults undergoing surgery, primarily hernia and varicose vein procedures. The main research questions are: * Does a preoperative VR mindfulness intervention reduce anxiety before surgery? * Does this reduction in anxiety result in lower postoperative pain compared to usual care? * Does the intervention help prevent chronic pain two weeks after surgery? Researchers will compare a VR mindfulness intervention group with a treatment-as-usual (TAU) group to assess the intervention's effectiveness. Participants will: * Be randomly assigned to one of two groups: * Experimental group: Receive a VR mindfulness session on the first day of hospitalization (one day before surgery). * Control group: Receive standard hospital care (no intervention). * Complete psychological and pain assessments at four time points: 1. Before the intervention (Day 1) 2. Immediately after the intervention (only the experimental group, Day 1) 3. After surgery (Day 2) 4. Two weeks after surgery (follow-up) * Report pain intensity using the Numeric Rating Scale (NRS) at four postoperative time points. Before enrollment, participants will undergo a structured interview to assess eligibility. This study aims to determine whether reducing preoperative anxiety through VR mindfulness contributes to improved pain management and a lower risk of developing chronic pain following surgery.
Trial Details
NCT Number NCT06961695
Lead Sponsor Babes-Bolyai University
Collaborators: Cluj-Napoca County Emergency Clinical Hospital, Surgery Department 2
Conditions Pain, Postoperative, Anxiety Preoperative
Enrollment 64 participants
Start Date 2025-05-12
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-07-05 (estimated)
Updated on ClinicalTrials.gov 2025-05-08