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

4. Juli 2026 aktualisiert von: Brandon Benchimol-Elkaim, McGill University
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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Operation Calm is a research study exploring whether virtual reality (VR) can help reduce anxiety in children and adolescents before surgery. Many young people experience significant worry, fear, or stress while preparing for a medical procedure, which can affect both their emotional wellbeing and their overall healthcare experience.

The study evaluates a novel VR mindfulness intervention designed for youth aged 10 to 17 years. Participants are randomly assigned to one of two groups: a VR-based mindfulness program or a standard mindfulness program. The VR intervention combines immersive 360-degree nature environments, such as forests, beaches, and underwater scenes, with guided mindfulness exercises that encourage relaxation, focused attention, and awareness of the present moment.

Researchers will examine whether the VR experience is feasible to deliver in a hospital setting, whether participants find it enjoyable and acceptable, and whether it shows promise for reducing anxiety before surgery. The study will also explore potential benefits for mindfulness, wellbeing, and feelings of connection to nature.

By investigating innovative and engaging ways to support young patients, Operation Calm aims to improve the surgical experience for children and adolescents and contribute to the development of accessible, evidence-based mental health supports within pediatric healthcare settings.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Virtual reality condition
This arm will receive the virtual reality intervention
Verhalten: 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.
Kein Eingriff: Control group
This arm receives the standard of care from the hospital

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Preoperative Anxiety
Zeitfenster: From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
State-Trait Anxiety Inventory for Children (STAIC)
Zeitfenster: From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
State-Trait Anxiety Inventory for Children (STAIC), State Anxiety Scale: A self-report questionnaire that assesses current ("state") anxiety. Scores range from 20 to 60, with higher scores indicating greater state anxiety (worse outcome).
From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
Current Pain and Anxiety Scale (CPAS)
Zeitfenster: From immediately before each intervention session to immediately after each intervention session.
Current Pain and Anxiety Scale: A self-report numeric rating scale used to assess participants' current pain and current anxiety. Pain and anxiety are each rated separately on a scale from 0 to 10, where 0 indicates no pain/anxiety and 10 indicates the worst possible pain/anxiety. Higher scores indicate greater pain or anxiety (worse outcomes).
From immediately before each intervention session to immediately after each intervention session.
Child and Adolescent Mindfulness Measure (CAMM)
Zeitfenster: From baseline prior to the intervention to up to 4 weeks following surgery.
Child and Adolescent Mindfulness Measure (CAMM): A 10-item self-report questionnaire that assesses trait mindfulness in children and adolescents. Total scores range from 0 to 40, with higher scores indicating greater mindfulness (better outcome).
From baseline prior to the intervention to up to 4 weeks following surgery.
Stirling Children's Well-being Scale (SCWBS)
Zeitfenster: From baseline prior to the intervention to up to 4 weeks following surgery.
Stirling Children's Well-being Scale (SCWBS): A 15-item self-report questionnaire that assesses psychological well-being in children and adolescents. Total scores range from 15 to 75, with higher scores indicating greater psychological well-being (better outcome).
From baseline prior to the intervention to up to 4 weeks following surgery.
Nature Connectedness Index (NCI)
Zeitfenster: From baseline prior to the intervention to up to 4 weeks following surgery.
Nature Connection Index (NCI): A self-report questionnaire that assesses an individual's subjective sense of connectedness with the natural world. Total scores range from 0 to 100, with higher scores indicating greater nature connectedness (better outcome).
From baseline prior to the intervention to up to 4 weeks following surgery.
Intervention completion rate
Zeitfenster: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
The proportion of participants randomized to the intervention who complete at least one virtual reality mindfulness session before surgery.
From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
Acceptability of the virtual reality mindfulness intervention measured by the Acceptability Questionnaire
Zeitfenster: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
Participant-rated acceptability of the intervention will be assessed using a post-intervention survey questionnaire about participants' experience. Qualitative data will be obtained. This is a custom-made questionnaire for this study.
From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
Simulator sickness measured by the Pediatric Simulator Sickness Questionnaire (Peds SSQ)
Zeitfenster: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
Pediatric Simulator Sickness Questionnaire (Peds SSQ): A self-report questionnaire assessing simulator sickness symptoms following virtual reality exposure. Total scores range from 0 to 90, with higher scores indicating greater simulator sickness (worse tolerability).
From enrollment through completion of the final study assessment, up to 4 weeks following surgery.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

McGill University

Mitarbeiter

Shriners Hospitals for Children,Canada

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. März 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

16. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juli 2026

Zuerst gepostet (Tatsächlich)

10. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • CAN2503

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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