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NCT Number: NCT07694934

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

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.

Why the study stopped: operational constraints beyond control of the study staff has forced the closure of the study.
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Key information

Conditions

Preoperative Anxiety Experienced by the Pediatric Patient

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Operation Calm EEMCF-VR

Behavioral

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.

Primary outcomes

  1. Preoperative Anxiety

    Time frame: 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).

Secondary outcomes

  1. State-Trait Anxiety Inventory for Children (STAIC)

    Time frame: From baseline immediately before the intervention to immediately following the intervention, prior to surgery.

    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).

  2. Current Pain and Anxiety Scale (CPAS)

    Time frame: From immediately before each intervention session to immediately after each intervention session.

    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).

  3. Child and Adolescent Mindfulness Measure (CAMM)

    Time frame: From baseline prior to the intervention to up to 4 weeks following surgery.

    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).

  4. Stirling Children's Well-being Scale (SCWBS)

    Time frame: From baseline prior to the intervention to up to 4 weeks following surgery.

    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).

  5. Nature Connectedness Index (NCI)

    Time frame: From baseline prior to the intervention to up to 4 weeks following surgery.

    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).

  6. Intervention completion rate

    Time frame: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.

    The proportion of participants randomized to the intervention who complete at least one virtual reality mindfulness session before surgery.

  7. Acceptability of the virtual reality mindfulness intervention measured by the Acceptability Questionnaire

    Time frame: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.

    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.

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

    Time frame: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.

    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).

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Aug 13, 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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