Operation Calm: VR Nature-Based Mindfulness to Reduce Pediatric Surgical Anxiety
11 de agosto de 2026 actualizado por: Brandon Benchimol-Elkaim, McGill University
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.
Descripción general del estudio
Estado
Retirado
Intervención / Tratamiento
Descripción detallada
Operation Calm is a research study exploring whether virtual reality (VR) can help reduce anxiety in children and adolescents before surgery. Many young people experience significant worry, fear, or stress while preparing for a medical procedure, which can affect both their emotional wellbeing and their overall healthcare experience.
The study evaluates a novel VR mindfulness intervention designed for youth aged 10 to 17 years. Participants are randomly assigned to one of two groups: a VR-based mindfulness program or a standard mindfulness program. The VR intervention combines immersive 360-degree nature environments, such as forests, beaches, and underwater scenes, with guided mindfulness exercises that encourage relaxation, focused attention, and awareness of the present moment.
Researchers will examine whether the VR experience is feasible to deliver in a hospital setting, whether participants find it enjoyable and acceptable, and whether it shows promise for reducing anxiety before surgery. The study will also explore potential benefits for mindfulness, wellbeing, and feelings of connection to nature.
By investigating innovative and engaging ways to support young patients, Operation Calm aims to improve the surgical experience for children and adolescents and contribute to the development of accessible, evidence-based mental health supports within pediatric healthcare settings.
Tipo de estudio
Intervencionista
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Montreal, Canadá
- Reclutamiento
- Shriners Hospital for Children - Canada
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Contacto:
- Argerie Tsimicalis
- Correo electrónico: argerie.tsimicalis@mcgill.ca
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Virtual reality condition
This arm will receive the virtual reality intervention
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Operation Calm is a virtual reality (VR) nature-based mindfulness intervention for youth aged 10-17 years awaiting surgery.
Participants engage in brief (<10 minute) immersive 360° nature experiences (e.g., forests, beaches, underwater environments) paired with guided mindfulness exercises focused on breathing, grounding, sensory awareness, and reflection on sources of calm and safety.
The intervention is specifically designed for use in pediatric surgical settings and aims to enhance engagement with mindfulness through immersive VR technology.
Participants in the control condition receive comparable mindfulness activities without the use of VR.
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Sin intervención: Control group
This arm receives the standard of care from the hospital
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Preoperative Anxiety
Periodo de tiempo: From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
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Measured using the Preoperative Anxiety Scale (PAS).
Anxiety levels will be assessed before and after the intervention to evaluate the effect of the VR mindfulness program on preoperative anxiety in youth undergoing surgery.
The Pediatric Anxiety Scale is a self-report measure of state anxiety.
Total scores range from 0 to 100, with higher scores indicating greater anxiety (i.e., a worse outcome).
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From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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State-Trait Anxiety Inventory for Children (STAIC)
Periodo de tiempo: From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
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State-Trait Anxiety Inventory for Children (STAIC), State Anxiety Scale: A self-report questionnaire that assesses current ("state") anxiety.
Scores range from 20 to 60, with higher scores indicating greater state anxiety (worse outcome).
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From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
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Current Pain and Anxiety Scale (CPAS)
Periodo de tiempo: From immediately before each intervention session to immediately after each intervention session.
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Current Pain and Anxiety Scale: A self-report numeric rating scale used to assess participants' current pain and current anxiety.
Pain and anxiety are each rated separately on a scale from 0 to 10, where 0 indicates no pain/anxiety and 10 indicates the worst possible pain/anxiety.
Higher scores indicate greater pain or anxiety (worse outcomes).
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From immediately before each intervention session to immediately after each intervention session.
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Child and Adolescent Mindfulness Measure (CAMM)
Periodo de tiempo: From baseline prior to the intervention to up to 4 weeks following surgery.
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Child and Adolescent Mindfulness Measure (CAMM): A 10-item self-report questionnaire that assesses trait mindfulness in children and adolescents.
Total scores range from 0 to 40, with higher scores indicating greater mindfulness (better outcome).
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From baseline prior to the intervention to up to 4 weeks following surgery.
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Stirling Children's Well-being Scale (SCWBS)
Periodo de tiempo: From baseline prior to the intervention to up to 4 weeks following surgery.
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Stirling Children's Well-being Scale (SCWBS): A 15-item self-report questionnaire that assesses psychological well-being in children and adolescents.
Total scores range from 15 to 75, with higher scores indicating greater psychological well-being (better outcome).
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From baseline prior to the intervention to up to 4 weeks following surgery.
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Nature Connectedness Index (NCI)
Periodo de tiempo: From baseline prior to the intervention to up to 4 weeks following surgery.
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Nature Connection Index (NCI): A self-report questionnaire that assesses an individual's subjective sense of connectedness with the natural world.
Total scores range from 0 to 100, with higher scores indicating greater nature connectedness (better outcome).
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From baseline prior to the intervention to up to 4 weeks following surgery.
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Intervention completion rate
Periodo de tiempo: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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The proportion of participants randomized to the intervention who complete at least one virtual reality mindfulness session before surgery.
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From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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Acceptability of the virtual reality mindfulness intervention measured by the Acceptability Questionnaire
Periodo de tiempo: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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Participant-rated acceptability of the intervention will be assessed using a post-intervention survey questionnaire about participants' experience.
Qualitative data will be obtained.
This is a custom-made questionnaire for this study.
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From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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Simulator sickness measured by the Pediatric Simulator Sickness Questionnaire (Peds SSQ)
Periodo de tiempo: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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Pediatric Simulator Sickness Questionnaire (Peds SSQ): A self-report questionnaire assessing simulator sickness symptoms following virtual reality exposure.
Total scores range from 0 to 90, with higher scores indicating greater simulator sickness (worse tolerability).
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From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de marzo de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
16 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de julio de 2026
Publicado por primera vez (Actual)
10 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- MMRL Operation Calm
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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