Trauma InjuryNCT05944315
Injury Prevention Model For K-1 Students
A study testing Education session in people with Trauma Injury and Child Behavior, run by Good Samaritan Hospital Medical Center, New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma Injury, Child Behavior
- What is being tested?
- Education session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- K-1 elementary school students in the catchment area of the hospital for educational sessions
Who cannot join
- No consent/assent for study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Good Samaritan Hospital
West Islip, New York, 11795
Stacey Pinto, MPH, 516-241-0906, stacey.pinto@chsil.org
About this study
Official title: Introducing A Replicable Model For Injury Prevention Education In Kindergarten And First Grade Students
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
Read the 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.
- Conditions
- Trauma Injury, Child Behavior
- Being tested
- Education session
- Keywords
- injury prevention, education model, elementary school children
- Medical subject headings
- Accidental Injuries, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education sessionBehavioural
Classroom Education session appropriate for elementary school children
| Study group | Role | What they receive |
|---|---|---|
| Teddy Bear Injury Prevention Clinic | Experimental | receiving injury prevention education Receives: Behavioral: Education session |
| Teddy Bear Hospital Education Clinic | Active comparator | receiving hospital based education Receives: Behavioral: Education session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Teddy Bear Injury Clinic for K-1 Students
Effectiveness of Teddy Bear Injury Clinic for K-1 Students for Injury Prevention Education
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start20 Jun 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Good Samaritan Hospital Medical Center, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinci Jones, MD, Principal investigator, Good Samaritan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944315
- Sponsor's protocol ID
- GoodSamaritanNY
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Limited de-identified data and limited study details as specified below
Publications
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.
PubMed 18847160Kis 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.
PubMed 35875438
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing A Replicable Model For Injury Prevention Education In Kindergarten And First Grade Students
- ClinicalTrials.gov ID
- NCT05944315
- Acronym / sponsor ID
- GoodSamaritanNY
- Conditions
- Trauma Injury, Child Behavior
- Keywords
- injury prevention, education model, elementary school children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Good Samaritan Hospital Medical Center, New YorkUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Teddy Bear Injury Prevention Clinic | Experimental | Behavioral: Education sessionreceiving injury prevention education |
| Teddy Bear Hospital Education Clinic | Active comparator | Behavioral: Education sessionreceiving hospital based education |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- K-1 elementary school students in the catchment area of the hospital for educational sessions
Key exclusion criteria (1 listed)
- No consent/assent for study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education sessionClassroom Education session appropriate for elementary school children | Behavioural | Teddy Bear Hospital Education Clinic, Teddy Bear Injury Prevention Clinic |
Primary outcome
Effectiveness of Teddy Bear Injury Clinic for K-1 Students
Time frame: 1 year
Effectiveness of Teddy Bear Injury Clinic for K-1 Students for Injury Prevention Education
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Results publication: PubMed 18847160Bloch 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 publication: PubMed 35875438Kis 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.
- Individual participant dataSharing planned: Yes. Limited de-identified data and limited study details as specified below
Related trials for Trauma Injury
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
Recruiting
Craniomaxillofacial and Upper Extremity Allotransplantation
Face Injuries, Hand Injuries
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinci Jones, MD principal investigator
Good Samaritan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education session in people with Trauma Injury and Child Behavior, run by Good Samaritan Hospital Medical Center, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vinci Jones, MD (6313763095, vincis.jones@chsil.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Teddy Bear Injury Clinic for K-1 Students (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05944315, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.