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: Recruiting
• Conditions: Trauma Injury; Child Behavior
• Intervention / Treatment: Behavioral: Education session

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: Interventional
• Enrollment (Estimated): 100
• 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

• United States
  • 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: Yes

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teddy Bear Injury Prevention Clinic; receiving injury prevention education	Behavioral: Education session; Classroom Education session appropriate for elementary school children
Active Comparator: Teddy Bear Hospital Education Clinic; receiving hospital based education	Behavioral: Education session; 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	Effectiveness of Teddy Bear Injury Clinic for K-1 Students for Injury Prevention Education	1 year

Collaborators and Investigators

• Sponsor: Good Samaritan Hospital Medical Center, New York
• 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): June 20, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: injury prevention; education model; elementary school children
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: GoodSamaritanNY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Limited de-identified data and limited study details as specified below
• IPD Sharing Time Frame: for 1 year after study termination
• IPD Sharing Access Criteria: write to investigators with description of information necessary and reason for request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No