Injury Prevention Model For K-1 Students

Child Behavior Clinical Trial

Official title:

Introducing A Replicable Model For Injury Prevention Education In Kindergarten And First Grade Students

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944315
• Other study ID #: GoodSamaritanNY
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: Good Samaritan Hospital Medical Center, New York
• Contact: Vinci Jones, MD
• Phone: 6313763095
• Email: vincis.jones[@]chsil.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

Inclusion Criteria:

• K-1 elementary school students in the catchment area of the hospital for educational sessions

Exclusion Criteria:

• No consent/assent for study

Related Conditions & MeSH terms

• Child Behavior
• Trauma Injury
• Wounds and Injuries

Intervention

Behavioral:
• Education session
Classroom Education session appropriate for elementary school children

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	West Islip	New York

Sponsors (1)

Lead Sponsor	Collaborator
Good Samaritan Hospital Medical Center, New York

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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.73 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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