Clinical Trial

Operation Calm: VR Nature-Based Mindfulness to Reduce Pediatric Surgical Anxiety

Withdrawn
View on ClinicalTrials.gov →
Why the trial stopped
operational constraints beyond control of the study staff has forced the closure of the study.
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.
Protocol Amendment History 3 changes
critical Trial status changed: Recruiting → Withdrawn 2026-08-14
critical Trial withdrawn: operational constraints beyond control of the study staff has forced the closure of the study. 2026-08-14
notable Enrollment reduced: 40 -> 0 participants 2026-08-14
Trial Details
NCT Number NCT07694934
Lead Sponsor McGill University
Conditions Preoperative Anxiety Experienced by the Pediatric Patient
Start Date 2026-03-10
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-13