Recruiting

VR Mindfulness

Sponsor:

McGill University

Code:

NCT07694934

Conditions

Preoperative Anxiety Experienced by the Pediatric Patient

Dental Anxiety in Children

Procedural Anxiety

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Accepted

Interventions

Operation Calm EEMCF-VR

Study Details

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

Study ID

NCT07694934

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Simulator sickness measured by the Pediatric Simulator Sickness Questionnaire (Peds SSQ) [ Time Frame: Baseline and Immediately after the intervention ]
  • Recruitment Rate [ Time Frame: Immediately after the intervention ]
  • Eligibility Rate [ Time Frame: At screening, before the intervention ]
  • Consent Rate [ Time Frame: At enrollment, before the intervention. ]
  • Intervention Completion Rate [ Time Frame: Immediately after the intervention. ]
  • Participants Experiencing Technical Difficulties [ Time Frame: Immediately after the intervention ]
  • Number of Technical Difficulties [ Time Frame: Immediately after the intervention ]
  • Early Discontinuation Rate [ Time Frame: Day 1, throughout the approximately 10-minute Operation Calm intervention ]
  • Child-Rated Acceptability of Operation Calm [ Time Frame: Immediately after completion of the intervention. ]
  • Parent-Rated Acceptability of Operation Calm [ Time Frame: Immediately after viewing the intervention. ]
  • Clinician-Rated Acceptability of Operation Calm [ Time Frame: Immediately after viewing the intervention. ]

Central Contacts and Locations

Central contacts

Brandon Benchimol-Elkaim

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

Locations

McGill University

Recruiting

Montreal, Canada

Contacts

Brandn Benchimol-Elkaim

514-398-4455brandon.benchimol-elkaim@mail.mcgill.ca

More Information

Sponsor

McGill University

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by McGill University on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.