Operation Calm: VR nature-based mindfulness for kids facing procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Operation Calm is a single-arm feasibility study using a virtual reality nature-based mindfulness intervention for children and adolescents aged 6 to 17, with input from parents and clinicians. Participants complete one guided VR session that combines immersive nature scenes with breathing, sensory awareness, and grounding exercises. The study assesses feasibility, acceptability, engagement, usability, and tolerability, and looks for immediate changes in anxiety, calmness, state mindfulness, and nature connection. Feedback from participants and observers will inform refinement before a larger trial in children preparing for medical or dental procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria

Children and Adolescents

* Aged 6-17 years
* Able to understand English or French
* Residing in Canada
* Have access to a smartphone compatible with the YouTube application and the study's smartphone-compatible VR headset
* Able to view the VR intervention and complete the study questionnaires
* Parent or legal guardian provides informed consent
* Child provides assent, or the adolescent provides consent, as applicable based on age and ethics requirements

Parents or Legal Guardians

* A parent or legal guardian of a child or adolescent aged 6-17 years
* Able to understand English or French
* Able to view the Operation Calm intervention through a secure online link and complete the study questionnaires
* Provides informed consent

Clinicians

* A healthcare professional with experience working with children or adolescents in medical, dental, or procedural care
* Able to understand English or French
* Able to view the Operation Calm intervention through a secure online link and complete the study questionnaires
* Provides informed consent

Exclusion Criteria

Children and Adolescents

* Unable to safely or comfortably use the VR headset
* Unable to view the intervention or complete the questionnaires
* Unable to provide assent or consent, as applicable
* Parent or legal guardian does not provide informed consent
* Any health, sensory, developmental, or technical limitation that, in the judgment of the research team, would prevent safe participation or completion of the study procedures

Parents and Clinicians

* Unable to understand English or French
* Unable to view the intervention or complete the study questionnaires
* Does not provide informed consent

Where it's running

• McGill University
  Montreal, Canada Recruiting

Study contacts

• Study coordinator: Brandon Benchimol-Elkaim
• Email: brandon.benchimol-elkaim@mail.mcgill.ca
• Phone: 5147154402

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.