Recruiting

VR Mindfulness

Sponsor:

McGill University

Code:

NCT07694934

Conditions

Preoperative Anxiety Experienced by the Pediatric Patient

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

Operation Calm EEMCF-VR

Study Details

Brief summary:

Operation Calm is a pilot randomized controlled trial investigating the feasibility, acceptability, and preliminary effectiveness of a virtual reality (VR) nature-based mindfulness intervention for reducing preoperative anxiety in children and adolescents aged 10-17 years undergoing surgery. Participants are randomly assigned to either a VR mindfulness condition, which combines immersive 360° nature environments with guided mindfulness exercises, or a standard mindfulness control condition. The study also examines changes in trait mindfulness, wellbeing, and nature connectedness, while monitoring participant engagement and tolerability. Findings will help determine whether VR-enhanced mindfulness is a practical and promising approach for supporting youth facing surgical procedures and will inform the design of future larger-scale clinical trials.

Conditions

Preoperative Anxiety Experienced by the Pediatric Patient

Study ID

NCT07694934

Start date

Mar 10, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pediatric patients aged 10-17 years.
  • Scheduled for surgery at SHC-Canada
  • Ability to use Virtual Reality (VR) equipment, including wearing VR goggles and following mindfulness program instructions.
  • No reported experience with a VR-MBI intervention for anxiety reduction.
  • Sufficient proficiency in English or French to understand and follow the VR mindfulness program, complete study-related questionnaires/forms.

Exclusion Criteria:

  • Participant being screened report cognitive or physical impairments that limit the ability to participate in mindfulness exercises or use VR technology (self or parent-report).
  • Participant being screened reports severe psychiatric conditions or use of medications that significantly alter anxiety levels (as assessed using the Youth Pediatric Symptom Checklist (self or parent-report).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Virtual reality condition

This arm will receive the virtual reality intervention

no intervention: Control group

This arm receives the standard of care from the hospital

Interventions

Operation Calm EEMCF-VR

Operation Calm is a virtual reality (VR) nature-based mindfulness intervention for youth aged 10-17 years awaiting surgery. Participants engage in brief (<10 minute) immersive 360° nature experiences (e.g., forests, beaches, underwater environments) paired with guided mindfulness exercises focused on breathing, grounding, sensory awareness, and reflection on sources of calm and safety. The intervention is specifically designed for use in pediatric surgical settings and aims to enhance engagement with mindfulness through immersive VR technology. Participants in the control condition receive comparable mindfulness activities without the use of VR.

Primary outcome measure

  • Preoperative Anxiety [ Time Frame: From baseline immediately before the intervention to immediately following the intervention, prior to surgery. ]

Central Contacts and Locations

Central contacts

Brandon Benchimol-Elkaim

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

Locations

Shriners Hospital for Children - Canada

Recruiting

Montreal, Canada

Contacts

Argerie Tsimicalis

argerie.tsimicalis@mcgill.ca

More Information

Sponsor

McGill University

Last update posted

Jul 10, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2026-07-10.