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Evaluating Operation Calm With Children, Parents, and Clinicians

Sponsor: McGill University • ClinicalTrials.gov ID: NCT07694934

Registry updated: 2026-10-07

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Description

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 360° 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.

Interventions

Operation Calm EEMCF-VR (Behavioral)
Operation Calm is a virtual reality (VR) nature-based mindfulness intervention for children and adolescents aged 6-17 years. Children complete one brief immersive 360° nature experience paired with guided mindfulness exercises focused on paced breathing, grounding, sensory awareness, present-moment attention, and reflection on calm and safety. Each child is assigned one of five nature scenes and views the intervention using a smartphone-compatible VR headset. The intervention is designed to teach coping skills that may eventually support children facing medical or dental procedures. Parents and clinicians view the intervention through a secure online link and provide feedback. This is a single-arm feasibility study and does not include a control condition.

Eligibility criteria

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

Conditions

Preoperative Anxiety Experienced by the Pediatric Patient Dental Anxiety in Children Procedural Anxiety

Locations

McGill University — Montreal, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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