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

NCT07694934 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-08-13

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-10
Primary Completion
2026-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07694934 on ClinicalTrials.gov