- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05944315
Injury Prevention Model For K-1 Students
Introducing A Replicable Model For Injury Prevention Education In Kindergarten And First Grade Students
There is no educational injury prevention model uniquely suited for kindergarten and first grade (K-1) students. The Teddy Bear Injury Clinic (TBIC) is a unique modification of the teddy bear clinic to facilitate classroom injury prevention teaching
The TBIC will be administered to K-1 students, aged 5-7 years. Initial analysis will be descriptive and qualitative. Subsequent randomization of students to test and control groups followed by statistical analysis will be done to evaluate for effectiveness of the educational model
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The TBIC is a 40minute educational intervention divided into two sections with the first section consisting of classroom teaching with two safety messages each for four safety topics and the second section being that of students acting as caregivers for their teddy bears, using role-play for the messages taught.
Qualitative data collection will be initially done in an inductive manner and qualitative content analysis done using the directed method to analyze effectiveness and appropriateness of the TBIC for a pilot group.
Controlled trial will consist of randomizing students to either the TBIC group or the control group which will receive an alternate teddy bear clinic for non trauma related hospital education. Pre and post questionnaires will be administered to evaluate the efficacy of the TBIC.
Statistical analysis will be done using the Wilcoxon signed test rank score for the Likert scale based evaluations generated.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vinci Jones, MD
- Phone Number: 6313763095
- Email: vincis.jones@chsil.org
Study Contact Backup
- Name: Stacey Pinto, MPH
- Phone Number: 5162410906
- Email: stacey.pinto@chsil.org
Study Locations
-
-
New York
-
West Islip, New York, United States, 11795
- Recruiting
- Good Samaritan Hospital
-
Contact:
- Stacey Pinto, MPH
- Phone Number: 516-241-0906
- Email: stacey.pinto@chsil.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- K-1 elementary school students in the catchment area of the hospital for educational sessions
Exclusion Criteria:
- No consent/assent for study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teddy Bear Injury Prevention Clinic
receiving injury prevention education
|
Classroom Education session appropriate for elementary school children
|
|
Active Comparator: Teddy Bear Hospital Education Clinic
receiving hospital based education
|
Classroom Education session appropriate for elementary school children
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of Teddy Bear Injury Clinic for K-1 Students
Time Frame: 1 year
|
Effectiveness of Teddy Bear Injury Clinic for K-1 Students for Injury Prevention Education
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vinci Jones, MD, Good Samaritan Hospital
Publications and helpful links
General Publications
- Bloch YH, Toker A. Doctor, is my teddy bear okay? The "Teddy Bear Hospital" as a method to reduce children's fear of hospitalization. Isr Med Assoc J. 2008 Aug-Sep;10(8-9):597-9.
- Kis H, Endres K, Karwowska A, Harrison M, Lau S, Lemire O, Zucker M. "Teddy Bear Hospital Project" school visits improve pre-clerkship students' comfort explaining medical concepts to children. Can Med Educ J. 2022 Jul 6;13(3):70-74. doi: 10.36834/cmej.73167. eCollection 2022 Jul.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GoodSamaritanNY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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