Feasibility, Acceptability, and Tolerability of Operation Calm: A Mixed-Methods Evaluation With Children, Parents, and Clinicians
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Simulator sickness measured by the Pediatric Simulator Sickness Questionnaire (Peds SSQ)
研究概览
简要总结
Operation Calm is a single-arm, mixed-methods feasibility study evaluating a virtual reality (VR) nature-based mindfulness intervention with children and adolescents aged 6-17 years, parents, and clinicians. Children complete one guided mindfulness session combining an immersive 360° nature environment with breathing, sensory awareness, and grounding exercises. Parents and clinicians view the intervention through a secure online link. The study examines feasibility, acceptability, engagement, usability, perceived usefulness, and child tolerability. It also explores immediate changes in children's anxiety, calmness, state mindfulness, and nature connectedness. Feedback from children, parents, and clinicians will guide further refinement of Operation Calm before it is evaluated in a larger clinical study.
详细描述
Operation Calm is a research study evaluating a virtual reality (VR) nature-based mindfulness intervention for children and adolescents aged 6 to 17 years. The intervention is designed to help young people practise coping skills that may be useful when facing medical or dental procedures, including breathing, sensory awareness, grounding, and present-moment attention.
Children will complete one guided mindfulness session within an immersive 360-degree nature environment, such as a forest, beach, or underwater scene. Parents and clinicians will view the intervention through a secure online link and provide feedback from their perspectives.
Researchers will examine whether the intervention and study procedures are feasible, understandable, acceptable, engaging, and easy to use. The study will also assess children's comfort and any VR-related symptoms and explore immediate changes in anxiety, calmness, state mindfulness, and connection to nature.
Feedback from children, parents, and clinicians will help identify needed improvements to the intervention's content, language, duration, delivery, accessibility, and safety. The findings will guide the refinement of Operation Calm before it is evaluated with children preparing for medical or dental procedures in a larger clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and Adolescents
- •Aged 6-17 years
- •Able to understand English or French
- •Residing in Canada
- •Have access to a smartphone compatible with the YouTube application and the study's smartphone-compatible VR headset
- •Able to view the VR intervention and complete the study questionnaires
- •Parent or legal guardian provides informed consent
- •Child provides assent, or the adolescent provides consent, as applicable based on age and ethics requirements
- •Parents or Legal Guardians
- •A parent or legal guardian of a child or adolescent aged 6-17 years
- •Able to understand English or French
- •Able to view the Operation Calm intervention through a secure online link and complete the study questionnaires
- •Provides informed consent
- •A healthcare professional with experience working with children or adolescents in medical, dental, or procedural care
- •Able to understand English or French
- •Able to view the Operation Calm intervention through a secure online link and complete the study questionnaires
- •Provides informed consent
排除标准
- •Children and Adolescents
- •Unable to safely or comfortably use the VR headset
- •Unable to view the intervention or complete the questionnaires
- •Unable to provide assent or consent, as applicable
- •Parent or legal guardian does not provide informed consent
- •Any health, sensory, developmental, or technical limitation that, in the judgment of the research team, would prevent safe participation or completion of the study procedures
- •Parents and Clinicians
- •Unable to understand English or French
- •Unable to view the intervention or complete the study questionnaires
- •Does not provide informed consent
研究组 & 干预措施
Operation Calm Intervention
Children and adolescents aged 6-17 years will complete one guided Operation Calm session using a smartphone-compatible virtual reality headset. The session combines an immersive 360° nature environment with guided mindfulness exercises involving paced breathing, sensory awareness, grounding, and present-moment attention. Each child will view one of five nature scenes. Parents and clinicians will view the intervention through a secure online link without using a VR headset and will provide feedback on its acceptability, appropriateness, usefulness, and feasibility.
干预措施: Operation Calm EEMCF-VR (Behavioral)
结局指标
主要结局
Simulator sickness measured by the Pediatric Simulator Sickness Questionnaire (Peds SSQ)
时间窗: Baseline and Immediately after the intervention
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).
Recruitment Rate
时间窗: Immediately after the intervention
Percentage of individuals who enroll in the study among all individuals approached or responding to recruitment materials. Calculated as: number enrolled ÷ number approached or responding × 100. Unit of Measure: Percentage of individuals
Eligibility Rate
时间窗: At screening, before the intervention
Percentage of screened individuals who meet the study eligibility criteria. Calculated as: number eligible ÷ number screened × 100.
Consent Rate
时间窗: At enrollment, before the intervention.
Percentage of eligible individuals who provide informed consent or parental consent and child assent, as applicable. Calculated as: number consenting ÷ number eligible × 100.
Intervention Completion Rate
时间窗: Immediately after the intervention.
Percentage of enrolled participants who complete the assigned Operation Calm session. Calculated as: number completing the intervention ÷ number enrolled × 100.
Participants Experiencing Technical Difficulties
时间窗: Immediately after the intervention
Percentage of intervention sessions during which at least one technical difficulty occurs, including difficulties involving the virtual reality headset, smartphone, video playback, audio, internet connection, or study link. Calculated as: sessions with at least one technical difficulty ÷ total sessions initiated × 100.
Number of Technical Difficulties
时间窗: Immediately after the intervention
Total number of technical difficulties recorded during intervention delivery. Multiple technical difficulties may be recorded during a single session.
Early Discontinuation Rate
时间窗: Day 1, throughout the approximately 10-minute Operation Calm intervention
Percentage of participants who begin but discontinue the Operation Calm session before completing it. Calculated as: number discontinuing early ÷ number beginning the intervention × 100.
Child-Rated Acceptability of Operation Calm
时间窗: Immediately after completion of the intervention.
Child-rated acceptability will be assessed using the quantitative items of the Operation Calm Child Evaluation Questionnaire. The questionnaire assesses comprehension, engagement, usability, appropriateness, perceived usefulness, and satisfaction. An overall acceptability score will be calculated as the mean of the applicable items. Higher scores indicate greater acceptability.
Parent-Rated Acceptability of Operation Calm
时间窗: Immediately after viewing the intervention.
Parent-rated acceptability will be assessed using the quantitative items of the Operation Calm Parent Evaluation Questionnaire. The questionnaire assesses comprehension, appropriateness, perceived usefulness, satisfaction, and perceptions of the intervention's suitability for children and adolescents. An overall acceptability score will be calculated as the mean of the applicable items. Higher scores indicate greater acceptability.
Clinician-Rated Acceptability of Operation Calm
时间窗: Immediately after viewing the intervention.
Clinician-rated acceptability will be assessed using the quantitative items of the Operation Calm Clinician Evaluation Questionnaire. The questionnaire assesses appropriateness, usability, perceived usefulness, satisfaction, and perceived suitability for use before medical or dental procedures. An overall acceptability score will be calculated as the mean of the applicable items. Higher scores indicate greater acceptability.
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
- Change in Current Anxiety(Immediately before and immediately after the intervention, within the single study session.)
- Change in Current Calmness(Immediately before and immediately after the intervention, within the single study session.)
- Missing Questionnaire Data(Immediately after the intervention.)
- Questionnaire Completion Rate(Immediately after the intervention.)
- 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