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RECRUITING
NCT07694934
NA

Evaluating Operation Calm With Children, Parents, and Clinicians

Sponsor: McGill University

View on ClinicalTrials.gov

Summary

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.

Official title: Feasibility, Acceptability, and Tolerability of Operation Calm: A Mixed-Methods Evaluation With Children, Parents, and Clinicians

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-10-01

Completion Date

2027-12

Last Updated

2026-10-07

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Operation Calm EEMCF-VR

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.

Locations (1)

McGill University

Montreal, Canada