Clinical trial NCT05944315: 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
Overall status: RECRUITING
Phase: NA
Conditions: Trauma Injury
Child Behavior
Keywords: injury prevention
education model
elementary school children
Lead sponsor: Good Samaritan Hospital Medical Center, New York
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Effectiveness of Teddy Bear Injury Clinic for K-1 Students
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: West Islip
country: United States
facility: Good Samaritan Hospital
state: New York
Study officials:
affiliation: Good Samaritan Hospital
name: Vinci Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.