Operation Calm: VR Nature-Based Mindfulness to Reduce Pediatric Surgical Anxiety
Stopped: operational constraints beyond control of the study staff has forced the closure of the study.
0Started 2026-03-10
Plain-language summary
Operation Calm is a pilot randomized controlled trial investigating the feasibility, acceptability, and preliminary effectiveness of a virtual reality (VR) nature-based mindfulness intervention for reducing preoperative anxiety in children and adolescents aged 10-17 years undergoing surgery. Participants are randomly assigned to either a VR mindfulness condition, which combines immersive 360° nature environments with guided mindfulness exercises, or a standard mindfulness control condition. The study also examines changes in trait mindfulness, wellbeing, and nature connectedness, while monitoring participant engagement and tolerability. Findings will help determine whether VR-enhanced mindfulness is a practical and promising approach for supporting youth facing surgical procedures and will inform the design of future larger-scale clinical trials.
Who can participate
Age range
10 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pediatric patients aged 10-17 years.
* Ability to use Virtual Reality (VR) equipment, including wearing VR goggles and following mindfulness program instructions.
* No reported experience with a VR-MBI intervention for anxiety reduction.
* Sufficient proficiency in English or French to understand and follow the VR mindfulness program, complete study-related questionnaires/forms.
Exclusion Criteria:
* Participant being screened report cognitive or physical impairments that limit the ability to participate in mindfulness exercises or use VR technology (self or parent-report).
* Participant being screened reports severe psychiatric conditions or use of medications that significantly alter anxiety levels (as assessed using the Youth Pediatric Symptom Checklist (self or parent-report).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Preoperative Anxiety
Timeframe: From baseline immediately before the intervention to immediately following the intervention, prior to surgery.