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Withdrawn NCT07694934

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

Conditions: Preoperative Anxiety Experienced by the Pediatric Patient

Sex: All
Ages: 10 Years – 17 Years
Healthy volunteers: No
Phase: NA
Sponsor: McGill University

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.

Eligibility Criteria

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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07694934). StuddyBuddy aggregates publicly available trial information.