NCT05944315

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

July 6, 2023

Last Update Submit

July 6, 2023

Conditions

Keywords

injury preventioneducation modelelementary school children

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Teddy Bear Injury Prevention Clinic

EXPERIMENTAL

receiving injury prevention education

Behavioral: Education session

Teddy Bear Hospital Education Clinic

ACTIVE COMPARATOR

receiving hospital based education

Behavioral: Education session

Interventions

Classroom Education session appropriate for elementary school children

Teddy Bear Hospital Education ClinicTeddy Bear Injury Prevention Clinic

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • No consent/assent for study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Hospital

West Islip, New York, 11795, United States

RECRUITING

Related 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.

  • 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.

MeSH Terms

Conditions

Accidental InjuriesChild Behavior

Condition Hierarchy (Ancestors)

Wounds and InjuriesBehavior

Study Officials

  • Vinci Jones, MD

    Good Samaritan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinci Jones, MD

CONTACT

Stacey Pinto, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
injury prevention knowledge being assessed in comparison to control group
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 13, 2023

Study Start

June 20, 2023

Primary Completion

May 31, 2024

Study Completion

July 31, 2024

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Limited de-identified data and limited study details as specified below

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
for 1 year after study termination
Access Criteria
write to investigators with description of information necessary and reason for request

Locations