Evaluating Operation Calm With Children, Parents, and Clinicians

October 26, 2026 updated by: Brandon Benchimol-Elkaim, McGill University

Feasibility, Acceptability, and Tolerability of Operation Calm: A Mixed-Methods Evaluation 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Operation Calm EEMCF-VR

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and Immediately after the intervention
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
Immediately after the intervention
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.
At screening, before the intervention
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.
At enrollment, before the intervention.
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.
Immediately after the intervention.
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.
Immediately after the intervention
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.
Immediately after the intervention
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.
Day 1, throughout the approximately 10-minute Operation Calm intervention
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.
Immediately after completion of the intervention.
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.
Immediately after viewing the intervention.
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.
Immediately after viewing the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately before and immediately after the intervention, within the single study session.
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.
Immediately before and immediately after the intervention, within the single study session.
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.
Immediately after the intervention.
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.
Immediately after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

July 4, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

October 28, 2026

Last Update Submitted That Met QC Criteria

October 26, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MMRL Operation Calm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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