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Evaluating Operation Calm With Children, Parents, and Clinicians

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 100% 40 → 0 participants
See other at-risk trials from McGill University

Record History

  1. Recruitment opened Start date changed from estimate of Oct 10, 2026 to Oct 1, 2026 · Study sites: 0 to 1 Show 2 more changesShow less
    • Start date changed from estimate of Oct 10, 2026 to Oct 1, 2026
    • Study sites: 0 to 1
  2. Trial status changed: Withdrawn → Not Yet Recruiting Start date: Mar 10, 2026 to Oct 10, 2026 · Primary endpoints: 1 to 11 · Enrollment target: 0 to 150 · 8 more Show 11 more changesShow less
    • Start date: Mar 10, 2026 to Oct 10, 2026
    • Primary endpoints: 1 to 11
    • Enrollment target: 0 to 150
    • Primary completion date: Dec 2026 to Mar 2027
    • Completion date: Dec 2026 to Dec 2027
    • Eligibility criteria expanded, about 162 words
    • Secondary endpoints: 8 to 4
    • Study description shortened, about 17 words
    • Study sites shortened, about 6 words
    • Study arms: 2 to 1
    • Study title shortened, about 2 words
  3. Trial status changed: Recruiting → Withdrawn Sponsor's reason: operational constraints beyond control of the study staff has forced the closure of the study. Enrollment reduced: 40 → 0 participants · Eligibility criteria shortened, about 5 words · Collaborators shortened, about 4 wordsv2 Show 3 more changesShow less
    • Enrollment reduced: 40 → 0 participants
    • Eligibility criteria shortened, about 5 words
    • Collaborators shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
McGill University
47 trials monitored
See 6 trials at risk
Anxiety
2,264 trials monitored
See 97 trials at risk
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.
Trial Details
NCT Number NCT07694934
Lead Sponsor McGill University
Conditions Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children, Procedural Anxiety
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov