Operation Calm: VR Nature-Based Mindfulness to Reduce Pediatric Surgical Anxiety
11 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Retirado
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Montreal, Canadá
- Recrutamento
- Shriners Hospital for Children - Canada
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Contato:
- Argerie Tsimicalis
- E-mail: argerie.tsimicalis@mcgill.ca
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Sem intervenção: Control group
This arm receives the standard of care from the hospital
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Preoperative Anxiety
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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State-Trait Anxiety Inventory for Children (STAIC)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
10 de março de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
16 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de julho de 2026
Primeira postagem (Real)
10 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- MMRL Operation Calm
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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