The Efficacy of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients
Not yet recruitingNot applicableNCT06961695
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Assessing the Effectiveness of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients: A Controlled Clinical Study
- Conditions
- Pain, Postoperative
- Anxiety Preoperative
- Interventions
- Behavioral: VR Mindfulness-Based Relaxation
- Sponsor
- Babes-Bolyai University
- Collaborators
- Cluj-Napoca County Emergency Clinical Hospital, Surgery Department 2
- Start date
- 2025-05-12
- Primary completion
- 2025-06-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria * The participant is scheduled for surgery and is currently hospitalized for hernia or varicose vein procedures. * The participant is on the hospital's surgical waiting list. * The participant is willing and able to provide informed consent. * The participant agrees to participate in the study and to complete all required assessments during hospitalization and at follow-up (either at home or during post-operative medical visits). Exclusion Criteria * Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia); mild cognitive impairment does not constitute an exclusion criterion. * Limited proficiency in the Romanian language. * Active substance use or alcohol use disorders that, in the opinion of the investigators, may interfere with participation. * History of motion sickness. * Severe visual impairment (e.g., inability to see clearly without glasses); patients who use contact lenses are not excluded. * Use of strong opioids (e.g., morphine). * Current suicide risk.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06961695