Operation Calm: VR Nature-Based Mindfulness to Reduce Pediatric Surgical Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Preoperative Anxiety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Virtual reality condition
This arm will receive the virtual reality intervention
干预措施: Operation Calm EEMCF-VR (Behavioral)
Control group
This arm receives the standard of care from the hospital
结局指标
主要结局
Preoperative Anxiety
时间窗: From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
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).
次要结局
- State-Trait Anxiety Inventory for Children (STAIC)(From baseline immediately before the intervention to immediately following the intervention, prior to surgery.)
- Current Pain and Anxiety Scale (CPAS)(From immediately before each intervention session to immediately after each intervention session.)
- Child and Adolescent Mindfulness Measure (CAMM)(From baseline prior to the intervention to up to 4 weeks following surgery.)
- Stirling Children's Well-being Scale (SCWBS)(From baseline prior to the intervention to up to 4 weeks following surgery.)
- Nature Connectedness Index (NCI)(From baseline prior to the intervention to up to 4 weeks following surgery.)
- Intervention completion rate(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(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)(From enrollment through completion of the final study assessment, up to 4 weeks following surgery.)
研究者
Brandon Benchimol-Elkaim
Doctoral Researcher (Thesis Investigator)
McGill University