Operation Calm: VR Nature-Based Mindfulness to Reduce Pediatric Surgical Anxiety

NCT07694934 | Recruiting DMC

• 1 other identifier: CAN2503
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

preoperative anxiety; mindfulness; virtual reality; nature; pediatric

Outcome Measures

Primary Outcomes (1)

• Preoperative Anxiety

  Measured using the Preoperative Anxiety Scale (PAS). Anxiety levels will be assessed before and after the intervention to evaluate the effect of the VR mindfulness program on preoperative anxiety in youth undergoing surgery. The Pediatric Anxiety Scale is a self-report measure of state anxiety. Total scores range from 0 to 100, with higher scores indicating greater anxiety (i.e., a worse outcome).

  From baseline immediately before the intervention to immediately following the intervention, prior to surgery.

Secondary Outcomes (8)

• State-Trait Anxiety Inventory for Children (STAIC)

  From baseline immediately before the intervention to immediately following the intervention, prior to surgery.

• Current Pain and Anxiety Scale (CPAS)

  From immediately before each intervention session to immediately after each intervention session.

• Child and Adolescent Mindfulness Measure (CAMM)

  From baseline prior to the intervention to up to 4 weeks following surgery.

• Stirling Children's Well-being Scale (SCWBS)

  From baseline prior to the intervention to up to 4 weeks following surgery.

• Nature Connectedness Index (NCI)

  From baseline prior to the intervention to up to 4 weeks following surgery.

Study Arms (2)

Virtual reality condition

EXPERIMENTAL

This arm will receive the virtual reality intervention

Behavioral: Operation Calm EEMCF-VR

Control group

NO INTERVENTION

This arm receives the standard of care from the hospital

Interventions

Operation Calm EEMCF-VR BEHAVIORAL

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.

Virtual reality condition

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shriners Hospitals for Children,Canada: collaborator
• McGill University: lead

Study Sites (1)

Shriners Hospital for Children - Canada

Montreal, Canada

RECRUITING

Central Study Contacts

Brandon Benchimol-Elkaim

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher (Thesis Investigator)

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 10, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-06

Locations

CA (1)