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Virtual Reality Storytelling for Anxiety (STM Trial)

N/A
Recruiting
Led By Desigen Reddy, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children between the ages of 8-13 who are scheduled to receive any outpatient surgery (i.e. tonsillectomy, herniorrhaphy)
Be younger than 18 years old
Must not have
Children with known neurodevelopmental disorders
Children who are on psychotropic medications prior to randomization will be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for children aged 8-13 who are scheduled for outpatient surgery like tonsillectomy or herniorrhaphy. It's not suitable for kids with chronic illnesses, neurodevelopmental disorders, or those on psychotropic medications before the study starts.
What is being tested?
The trial tests a new interactive tablet-based Virtual Reality program called StoryTelling Medicine (STM), designed to reduce preoperative anxiety in children by familiarizing them with hospital settings before surgery.
What are the potential side effects?
Since STM is a non-invasive virtual reality storytelling experience, it does not have physical side effects like medications do. However, its impact on individual emotional and psychological responses will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child, aged 8-13, is scheduled for a minor outpatient surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My child has a diagnosed neurodevelopmental disorder.
Select...
I am not taking any psychotropic medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Salivary Cortisol
Secondary study objectives
Analgesic Usage
Anesthetics
Delirium
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interactive Virtual ApplicationExperimental Treatment1 Intervention
Online application
Group II: Standard of CareActive Control1 Intervention
No intervention and Hospital Standard of Care

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
917 Previous Clinical Trials
2,616,236 Total Patients Enrolled
7 Trials studying Anxiety
596 Patients Enrolled for Anxiety
Desigen Reddy, MDPrincipal InvestigatorHamilton Health Sciences Corporation

Media Library

StoryTelling Medicine Application Clinical Trial Eligibility Overview. Trial Name: NCT02687243 — N/A
Anxiety Research Study Groups: Interactive Virtual Application, Standard of Care
Anxiety Clinical Trial 2023: StoryTelling Medicine Application Highlights & Side Effects. Trial Name: NCT02687243 — N/A
StoryTelling Medicine Application 2023 Treatment Timeline for Medical Study. Trial Name: NCT02687243 — N/A
~20 spots leftby Dec 2025
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