Evaluating Operation Calm With Children, Parents, and Clinicians

NCT ID
NCT07694934
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
McGill University
Conditions
Dental Anxiety in Children, Preoperative Anxiety Experienced by the Pediatric Patient, Procedural Anxiety

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: Feasibility, Acceptability, and Tolerability of Operation Calm: A Mixed-Methods Evaluation With Children, Parents, and Clinicians

Enrollment: 150 participants (Estimated).

What is being studied

  • Behavioral: Operation Calm EEMCF-VR

Who may be eligible

Ages
6 Years to no maximum
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

No study locations are listed in the registry data.

Study details

Start date
October 10, 2026
Primary completion date
March 1, 2027
Completion date
December 1, 2027
First posted
July 10, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07694934
Registry last updated
September 25, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07694934 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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