Preoperative Anxiety Experienced by the Pediatric PatientNCT07694934
Evaluating Operation Calm With Children, Parents, and Clinicians
A study testing Operation Calm EEMCF-VR in people with Preoperative Anxiety Experienced by the Pediatric Patient and Dental Anxiety in Children, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children, Procedural Anxiety
- What is being tested?
- Operation Calm EEMCF-VR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Parents and Clinicians
- Unable to understand English or French
- Unable to view the intervention or complete the study questionnaires
- Does not provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University
Montreal
Brandn Benchimol-Elkaim, 514-398-4455, brandon.benchimol-elkaim@mail.mcgill.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children, Procedural Anxiety
- Being tested
- Operation Calm EEMCF-VR
- Keywords
- preoperative anxiety, mindfulness, virtual reality, nature, pediatric, dental anxiety, procedural anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operation Calm EEMCF-VRBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Operation Calm EEMCF-VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Immediately after the intervention
Eligibility Rate
Percentage of screened individuals who meet the study eligibility criteria. Calculated as: number eligible ÷ number screened × 100.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after viewing the intervention.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Oct 2026
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Anxiety Experienced by the Pediatric PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon Benchimol-Elkaim, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694934
- Sponsor's protocol ID
- MMRL Operation Calm
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided