An interventional study of Operation Calm EEMCF-VR in Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children and Procedural Anxiety, sponsored by McGill University. Recruiting at 1 site in Canada. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by McGill University · Not applicable, Interventional, and Prevention
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.
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.
McGill University is the lead sponsor of 249 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children and Adolescents
Parents or Legal Guardians
Clinicians
Exclusion Criteria
Children and Adolescents
Parents and Clinicians
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Time frame: 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
Time frame: Immediately after the intervention
Eligibility Rate
Percentage of screened individuals who meet the study eligibility criteria. Calculated as: number eligible ÷ number screened × 100.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after viewing the intervention.
Change in Current Anxiety
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.
Time frame: Immediately before and immediately after the intervention, within the single study session.
Change in Current Calmness
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.
Time frame: Immediately before and immediately after the intervention, within the single study session.
Missing Questionnaire Data
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.
Time frame: Immediately after the intervention.
Questionnaire Completion Rate
Percentage of participants who complete all required study questionnaires. Calculated as: number completing all required questionnaires ÷ number enrolled × 100.
Time frame: Immediately after the intervention.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Mar 2027, 5 months after the start.
Start moved twice since we started tracking on Sep 25, 2026: Mar 2026 → Oct 2026, last on Oct 7, 2026.
Primary completion moved once since we started tracking on Sep 25, 2026: Dec 2026 → Mar 2027, on Sep 25, 2026.
Completion moved once since we started tracking on Sep 25, 2026: Dec 2026 → Dec 2027, on Sep 25, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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