Operation Calm: VR Nature-Based Mindfulness to Reduce Pediatric Surgical Anxiety
11 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Retiré
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Montreal, Canada
- Recrutement
- Shriners Hospital for Children - Canada
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Contact:
- Argerie Tsimicalis
- E-mail: argerie.tsimicalis@mcgill.ca
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: Control group
This arm receives the standard of care from the hospital
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Preoperative Anxiety
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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State-Trait Anxiety Inventory for Children (STAIC)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 mars 2026
Achèvement primaire (Estimé)
1 décembre 2026
Achèvement de l'étude (Estimé)
1 décembre 2026
Dates d'inscription aux études
Première soumission
16 juin 2026
Première soumission répondant aux critères de contrôle qualité
4 juillet 2026
Première publication (Réel)
10 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- MMRL Operation Calm
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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