Evaluating Operation Calm With Children, Parents, and Clinicians

NCT07694934 | Not Yet Recruiting DMC

• 1 other identifier: MMRL Operation Calm
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

preoperative anxiety; mindfulness; virtual reality; nature; pediatric; dental anxiety; procedural anxiety

Outcome Measures

Primary Outcomes (11)

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

  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

  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

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

  At screening, before the intervention

• Consent Rate

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (4)

• 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.

Study Arms (1)

Operation Calm Intervention

EXPERIMENTAL

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

Interventions

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.

Operation Calm Intervention

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

Central Study Contacts

Brandon Benchimol-Elkaim

CONTACT

5147154402; brandon.benchimol-elkaim@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher (Thesis Investigator)

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

CA (1)