Study Summary
This trial is testing a new intervention, StoryTelling Medicine (STM), to help reduce anxiety in children undergoing elective surgery, and its associated negative effects.
Eligible Conditions
- Anxiety
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
3 Primary · 6 Secondary · Reporting Duration: One month
Baseline and Day 1
Change in Heart rate
Change in Salivary Cortisol
Day 1
Change in Preoperative anxiety
Day 1
Analgesic Usage
Anesthetics
Anesthetic induction compliance
Delirium
Length of Stay
One month
Post-Hospital Behaviour
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Standard of Care
1 of 2
Interactive Virtual Application
1 of 2
Active Control
Experimental Treatment
118 Total Participants · 2 Treatment Groups
Primary Treatment: Interactive Virtual Application · No Placebo Group · N/A
Interactive Virtual Application
Device
Experimental Group · 1 Intervention: Interactive Virtual Application · Intervention Types: DeviceStandard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one month
Who is running the clinical trial?
McMaster UniversityLead Sponsor
835 Previous Clinical Trials
2,632,702 Total Patients Enrolled
5 Trials studying Anxiety
341 Patients Enrolled for Anxiety
Desigen Reddy, MDPrincipal InvestigatorHamilton Health Sciences Corporation
Eligibility Criteria
Age 8 - 13 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Chow, Cheryl H. T., Ryan J. Van Lieshout, Louis A. Schmidt, Kathleen G. Dobson, and Norman Buckley. 2015. “Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery”. Journal of Pediatric Psychology. Oxford University Press (OUP). doi:10.1093/jpepsy/jsv094.
- Chow CH, Van Lieshout RJ, Schmidt LA, Dobson KG, Buckley N. Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery. J Pediatr Psychol. 2016 Mar;41(2):182-203. doi: 10.1093/jpepsy/jsv094. Epub 2015 Oct 17.
- 2019. "StoryTelling Medicine Application Using a Virtual Reality Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02687243.