Operation Calm: VR Nature-Based Mindfulness to Reduce Pediatric Surgical Anxiety

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Operation Calm EEMCF-VR
  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 engagemen

Первичные конечные точки

• Preoperative Anxiety [Срок оценки: From baseline immediately before the intervention to immediately following the intervention, prior to surgery.]

Вторичные конечные точки (8)

• State-Trait Anxiety Inventory for Children (STAIC) [Срок оценки: From baseline immediately before the intervention to immediately following the intervention, prior to surgery.]
• Current Pain and Anxiety Scale (CPAS) [Срок оценки: From immediately before each intervention session to immediately after each intervention session.]
• Child and Adolescent Mindfulness Measure (CAMM) [Срок оценки: From baseline prior to the intervention to up to 4 weeks following surgery.]
• Stirling Children's Well-being Scale (SCWBS) [Срок оценки: From baseline prior to the intervention to up to 4 weeks following surgery.]
• Nature Connectedness Index (NCI) [Срок оценки: From baseline prior to the intervention to up to 4 weeks following surgery.]
• Intervention completion rate [Срок оценки: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.]
• Acceptability of the virtual reality mindfulness intervention measured by the Acceptability Questionnaire [Срок оценки: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.]
• Simulator sickness measured by the Pediatric Simulator Sickness Questionnaire (Peds SSQ) [Срок оценки: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.]

Критерии участия

Критерии включения

• Pediatric patients aged 10-17 years.
• Scheduled for surgery at SHC-Canada
• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

• Shriners Hospital for Children - Canada — Montreal

Идентификаторы

NCT: NCT07694934 · CAN2503

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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