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NCT Number: NCT07694934

Evaluating Operation Calm With Children, Parents, and Clinicians

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.

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Key information

Conditions

Preoperative Anxiety Experienced by the Pediatric Patient Dental Anxiety in Children Procedural Anxiety

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Clinicians

  • 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

Exclusion criteria

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

Treatment and study plan

Operation Calm EEMCF-VR

Behavioral

Operation Calm is a virtual reality (VR) nature-based mindfulness intervention for children and adolescents aged 6-17 years. Children complete one brief immersive 360° nature experience paired with guided mindfulness exercises focused on paced breathing, grounding, sensory awareness, present-moment attention, and reflection on calm and safety. Each child is assigned one of five nature scenes and views the intervention using a smartphone-compatible VR headset. The intervention is designed to teach coping skills that may eventually support children facing medical or dental procedures. Parents and clinicians view the intervention through a secure online link and provide feedback. This is a single-arm feasibility study and does not include a control condition.

Primary outcomes

  1. Simulator sickness measured by the Pediatric Simulator Sickness Questionnaire (Peds SSQ)

    Time frame: 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).

  2. Recruitment Rate

    Time frame: 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

  3. Eligibility Rate

    Time frame: At screening, before the intervention

    Percentage of screened individuals who meet the study eligibility criteria. Calculated as: number eligible ÷ number screened × 100.

  4. Consent Rate

    Time frame: 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.

  5. Intervention Completion Rate

    Time frame: Immediately after the intervention.

    Percentage of enrolled participants who complete the assigned Operation Calm session. Calculated as: number completing the intervention ÷ number enrolled × 100.

  6. Participants Experiencing Technical Difficulties

    Time frame: 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.

  7. Number of Technical Difficulties

    Time frame: Immediately after the intervention

    Total number of technical difficulties recorded during intervention delivery. Multiple technical difficulties may be recorded during a single session.

  8. Early Discontinuation Rate

    Time frame: 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.

  9. Child-Rated Acceptability of Operation Calm

    Time frame: 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.

  10. Parent-Rated Acceptability of Operation Calm

    Time frame: 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.

  11. Clinician-Rated Acceptability of Operation Calm

    Time frame: 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.

Secondary outcomes

  1. Change in Current Anxiety

    Time frame: Immediately before and immediately after the intervention, within the single study session.

    Children will rate their current anxiety using a visual scale ranging from 0 to 10, where 0 means "not anxious at all" and 10 means "extremely anxious." Ratings will be completed immediately before and after Operation Calm and compared to explore immediate change. This outcome is exploratory and will not be interpreted as evidence of clinical effectiveness.

  2. Change in Current Calmness

    Time frame: Immediately before and immediately after the intervention, within the single study session.

    Children will rate their current calmness using a visual scale ranging from 0 to 10, where 0 means "not calm at all" and 10 means "completely calm." Ratings will be completed immediately before and after Operation Calm and compared to explore immediate change.

  3. Missing Questionnaire Data

    Time frame: Immediately after the intervention.

    Percentage of expected questionnaire items that are missing across all required study questionnaires. Calculated as: number of unanswered items ÷ total number of expected questionnaire items × 100.

  4. Questionnaire Completion Rate

    Time frame: Immediately after the intervention.

    Percentage of participants who complete all required study questionnaires. Calculated as: number completing all required questionnaires ÷ number enrolled × 100.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

Feasibility, Acceptability, and Tolerability of Operation Calm: A Mixed-Methods Evaluation With Children, Parents, and Clinicians

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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