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โ† Trials
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Evaluating Operation Calm With Children, Parents, and Clinicians

RecruitingNAAges 6 Years - anyAllMcGill University
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In plain words

What the trial is, and whether it could suit you

Operation Calm is a single-arm, mixed-methods feasibility study evaluating a virtual reality (VR) nature-based mindfulness intervention with children and adolescents aged 6-17 years, parents, and clinicians. Children complete one guided mindfulness session combining an immersive 360ยฐ nature environment with breathing, sensory awareness, and grounding exercises. Parents and clinicians view the intervention through a secure online link. The study examines feasibility, acceptability, engagement, usability, perceived usefulness, and child tolerability. It also explores immediate changes in children's anxiety, calmness, state mindfulness, and nature connectedness. Feedback from children, parents, and clinicians will guide further refinement of Operation Calm before it is evaluated in a larger clinical study.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Operation Calm EEMCF-VR
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Where

1 site
McGill University
Montreal, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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