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Injury Prevention Model For K-1 Students

Primary Purpose

Trauma Injury, Child Behavior

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Education session

About this trial

This is an interventional prevention trial for Trauma Injury focused on measuring injury prevention, education model, elementary school children

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: K-1 elementary school students in the catchment area of the hospital for educational sessions Exclusion Criteria: No consent/assent for study

Sites / Locations

Good Samaritan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Teddy Bear Injury Prevention Clinic

Teddy Bear Hospital Education Clinic

Arm Description

receiving injury prevention education

receiving hospital based education

Outcomes

Primary Outcome Measures

Effectiveness of Teddy Bear Injury Clinic for K-1 Students

Effectiveness of Teddy Bear Injury Clinic for K-1 Students for Injury Prevention Education

Secondary Outcome Measures

Full Information

NCT ID

NCT05944315

First Posted

July 6, 2023

Last Updated

July 6, 2023

Sponsor

Good Samaritan Hospital Medical Center, New York

1. Study Identification

Unique Protocol Identification Number

NCT05944315

Brief Title

Injury Prevention Model For K-1 Students

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 20, 2023 (Actual)

Primary Completion Date

May 31, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Good Samaritan Hospital Medical Center, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trauma Injury, Child Behavior

Keywords

injury prevention, education model, elementary school children

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Cluster randomized controlled trial

Masking

Participant

Masking Description

injury prevention knowledge being assessed in comparison to control group

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Teddy Bear Injury Prevention Clinic

Arm Type

Experimental

Arm Description

receiving injury prevention education

Arm Title

Teddy Bear Hospital Education Clinic

Arm Type

Active Comparator

Arm Description

receiving hospital based education

Intervention Type

Behavioral

Intervention Name(s)

Education session

Intervention Description

Classroom Education session appropriate for elementary school children

Primary Outcome Measure Information:

Title

Effectiveness of Teddy Bear Injury Clinic for K-1 Students

Description

Effectiveness of Teddy Bear Injury Clinic for K-1 Students for Injury Prevention Education

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: K-1 elementary school students in the catchment area of the hospital for educational sessions Exclusion Criteria: No consent/assent for study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vinci Jones, MD

Phone

6313763095

vincis.jones@chsil.org

First Name & Middle Initial & Last Name or Official Title & Degree

Stacey Pinto, MPH

Phone

5162410906

stacey.pinto@chsil.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vinci Jones, MD

Organizational Affiliation

Good Samaritan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Good Samaritan Hospital

City

West Islip

State/Province

New York

ZIP/Postal Code

11795

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stacey Pinto, MPH

Phone

516-241-0906

stacey.pinto@chsil.org

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

18847160

Citation

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.

Results Reference

result

PubMed Identifier

35875438

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.73167. eCollection 2022 Jul.

Results Reference

result

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Injury Prevention Model For K-1 Students

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