Injury Prevention Model For K-1 Students

NCT ID: NCT05944315

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-20

Study Completion Date

2024-07-31

Brief Summary

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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

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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.

Conditions

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Trauma Injury Child Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
injury prevention knowledge being assessed in comparison to control group

Study Groups

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Teddy Bear Injury Prevention Clinic

receiving injury prevention education

Group Type EXPERIMENTAL

Education session

Intervention Type BEHAVIORAL

Classroom Education session appropriate for elementary school children

Teddy Bear Hospital Education Clinic

receiving hospital based education

Group Type ACTIVE_COMPARATOR

Education session

Intervention Type BEHAVIORAL

Classroom Education session appropriate for elementary school children

Interventions

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Education session

Classroom Education session appropriate for elementary school children

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No consent/assent for study
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Good Samaritan Hospital Medical Center, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vinci Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Good Samaritan Hospital

Locations

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Good Samaritan Hospital

West Islip, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vinci Jones, MD

Role: CONTACT

6313763095

Stacey Pinto, MPH

Role: CONTACT

5162410906

Facility Contacts

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Stacey Pinto, MPH

Role: primary

516-241-0906

References

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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.

Reference Type RESULT
PMID: 18847160 (View on PubMed)

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.

Reference Type RESULT
PMID: 35875438 (View on PubMed)

Other Identifiers

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GoodSamaritanNY

Identifier Type: -

Identifier Source: org_study_id

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