About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- VR Mindfulness-Based Relaxation
Treatment groups
Locations
Sponsors and collaborators
Babes-Bolyai University
Lead sponsor
Cluj-Napoca County Emergency Clinical Hospital, Surgery Department 2
Collaborator