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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month
Awards & highlights
STM Trial 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.Check my eligibility
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.See study design
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.
STM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child, aged 8-13, is scheduled for a minor outpatient surgery.
STM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Heart rate
Change in Preoperative anxiety
Change in Salivary Cortisol
Secondary outcome measures
Analgesic Usage
Anesthetics
Anesthetic induction compliance
+3 moreSTM 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
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Who is running the clinical trial?
McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,598,198 Total Patients Enrolled
6 Trials studying Anxiety
471 Patients Enrolled for Anxiety
Desigen Reddy, MDPrincipal InvestigatorHamilton Health Sciences Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child has a long-term illness like cancer.My child has a diagnosed neurodevelopmental disorder.I am not taking any psychotropic medications.My child, aged 8-13, is scheduled for a minor outpatient surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Interactive Virtual Application
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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