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The Effect of a Shaken Baby Syndrome Prevention Program

Primary Purpose

Shaken Baby Syndrome, Mothers

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Training program
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shaken Baby Syndrome focused on measuring awareness, knowledge, mothers, nursing, shaken baby syndrome

Eligibility Criteria

2 Months - 4 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Having a baby of 2-4 months, Free from physical or mental disability

Exclusion Criteria:

Unhealthy (mother or baby), Any SBS education in the last 2 years

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

İntervention group

Control group

Arm Description

Randomization with a sealed envelope will be applied to mothers who have 2-4 months old babies who apply to Akdeniz University Hospital Pediatric Outpatient Clinic for health control and who accept the study. A pre-test application will be made in the intervention group. The Researcher will fill in the Personal Information Form and the Shaken baby syndrome assessment survey at this stage. The training prepared to prevent shaken baby syndrome, which was prepared immediately after the end of the pre-test application, will be given to the mothers in the intervention group. The training will be given with mothers using one-to-one face-to-face interview method. Necessary equipment will be provided for training. At the end of the training, the questions of the mothers will be answered and a booklet prepared to prevent shaken baby syndrome will be given and tele-consultancy will be provided for 2 months.

No application will be made to the mothers in the control group after the pre-test application. After 2 months, the final test application will be made. After the last test, the mothers in the control group will be given a training and a booklet prepared to prevent shaken baby syndrome.

Outcomes

Primary Outcome Measures

Shaken baby syndrome knowledge level
The increase in the mother's level of knowledge about shaken baby syndrome is the outcome measure.This increase will be measured with "Shaken baby syndrome assessment survey". This form was developed by researchers. After the forms were developed, expert opinions were received from 10 academic members who are experts in the field of child health. It will be evaluated whether there is a statistically significant increase in the post-test data. Statistical analysis will be done using SPSS 23.0 and statistical significance will be set at p <0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2020
Last Updated
December 3, 2021
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT04568538
Brief Title
The Effect of a Shaken Baby Syndrome Prevention Program
Official Title
The Effect of a Shaken Baby Syndrome Prevention Program on Turkish Mothers' Awareness and Knowledge: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
February 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: This randomized controlled study aims to examine whether the education program prepared to prevent shaken baby syndrome has an effect on mothers' knowledge and attitudes. Method: Simple randomization will be used to evaluate the intervention and control groups. The study will be carried out with 90 mothers babies of 2-4 months, who applied to Akdeniz University Hospital Healthy Child Outpatient Clinic (intervention group: 45, control group: 45). After the pre-test, the mothers in the intervention group will be trained and a booklet will be given. Tele-consultancy service will be provided to mothers during the 2-month follow-up period. After 2 months of follow-up, a post-test will be applied to the mothers in the intervention group. The mothers in the control group will not be intervened after the pretest is applied. A post test will be applied 2 months after the pre-test. After the post-test, the mothers in the control group will be trained and a booklet will be given. Ethics committee approval and institutional permission were obtained for the study. Verbal and written consent will be obtained from the mothers during the data collection phase.
Detailed Description
Method: The study will be conducted with 90 mothers with 2-4 months old babies who applied to Akdeniz University Hospital Healthy Children Polyclinic (intervention group: 45, control group: 45). Personal Information Form, Shaken baby syndrome assessment survey will be used to collect data. Simple randomization will be used to evaluate the intervention and control groups. In order to identify mothers in intervention groups, sealed-envelope randomization method will used. Mothers and statistician group will be unaware of the evaluation. The researcher will not be blind because of the role he plays in the research. Following the pretest, the intervention group will be trained to prevent shaken baby syndrome. Expert opinion was obtained from 10 expert faculty members for the content of the training. After the training, the booklet prepared in line with expert opinions will be given to the mother in the intervention group. The booklet will remain with the mother. Tele-consultancy will be given to the mother for 2 months after the pre-test. The control group will also be tested beforehand and will not be intervened afterwards. 2 months after the pre-test, a post-test will be applied to the control group and training will be given to prevent shaken baby syndrome. A training booklet will be given to the mothers in the control group after the final test. Statistical analysis will be done using SPSS 23.0 and statistical significance will be set at p <0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shaken Baby Syndrome, Mothers
Keywords
awareness, knowledge, mothers, nursing, shaken baby syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind randomized controlled study
Masking
Participant
Masking Description
The statistician will be blind in evaluating the results. The intervention and control group will be defined as group 1 and group 2 for statistical analysis. Scales will be evaluated by the researcher who cannot be blinded due to the nature of the study.
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
İntervention group
Arm Type
Experimental
Arm Description
Randomization with a sealed envelope will be applied to mothers who have 2-4 months old babies who apply to Akdeniz University Hospital Pediatric Outpatient Clinic for health control and who accept the study. A pre-test application will be made in the intervention group. The Researcher will fill in the Personal Information Form and the Shaken baby syndrome assessment survey at this stage. The training prepared to prevent shaken baby syndrome, which was prepared immediately after the end of the pre-test application, will be given to the mothers in the intervention group. The training will be given with mothers using one-to-one face-to-face interview method. Necessary equipment will be provided for training. At the end of the training, the questions of the mothers will be answered and a booklet prepared to prevent shaken baby syndrome will be given and tele-consultancy will be provided for 2 months.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No application will be made to the mothers in the control group after the pre-test application. After 2 months, the final test application will be made. After the last test, the mothers in the control group will be given a training and a booklet prepared to prevent shaken baby syndrome.
Intervention Type
Other
Intervention Name(s)
Training program
Intervention Description
A training program and booklet content for the education to be given to mothers includes the following topics. What is shaken baby syndrome and what is its cause? What are the harms caused by shaken baby syndrome? How is shaken baby syndrome understood? What problems can shaken baby syndrome cause? What are the measures to be taken? For the training and the content of the booklet, expert opinion was obtained from 10 academic members who are experts in the field of Child Health. An evaluation form was created for pre-test and post-test measurements. Expert opinions were also received for these forms. Mothers of 2-4 months old babies who applied to Akdeniz University Hospital Pediatric Outpatient Clinic for check-up were randomized with a sealed envelope and accepted the study. In this way, intervention and control groups can be determined. After the pre-test is done in the intervention group, 2-month training, booklet and tele-consultancy services will be provided.
Primary Outcome Measure Information:
Title
Shaken baby syndrome knowledge level
Description
The increase in the mother's level of knowledge about shaken baby syndrome is the outcome measure.This increase will be measured with "Shaken baby syndrome assessment survey". This form was developed by researchers. After the forms were developed, expert opinions were received from 10 academic members who are experts in the field of child health. It will be evaluated whether there is a statistically significant increase in the post-test data. Statistical analysis will be done using SPSS 23.0 and statistical significance will be set at p <0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University.
Time Frame
2-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Having a baby of 2-4 months, Free from physical or mental disability Exclusion Criteria: Unhealthy (mother or baby), Any SBS education in the last 2 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayla KAYA, Dr.
Organizational Affiliation
Akdeniz University, Faculty of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University
City
Antalya
ZIP/Postal Code
07058
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27163220
Citation
Rideout L. Nurses' Perceptions of Barriers and Facilitators Affecting the Shaken Baby Syndrome Education Initiative: An Exploratory Study of a Massachusetts Public Policy. J Trauma Nurs. 2016 May-Jun;23(3):125-37. doi: 10.1097/JTN.0000000000000206.
Results Reference
background
PubMed Identifier
21940233
Citation
Bechtel K, Le K, Martin KD, Shah N, Leventhal JM, Colson E. Impact of an educational intervention on caregivers' beliefs about infant crying and knowledge of shaken baby syndrome. Acad Pediatr. 2011 Nov-Dec;11(6):481-6. doi: 10.1016/j.acap.2011.08.001. Epub 2011 Sep 21.
Results Reference
background
PubMed Identifier
22954642
Citation
Fujiwara T, Yamada F, Okuyama M, Kamimaki I, Shikoro N, Barr RG. Effectiveness of educational materials designed to change knowledge and behavior about crying and shaken baby syndrome: a replication of a randomized controlled trial in Japan. Child Abuse Negl. 2012 Sep;36(9):613-20. doi: 10.1016/j.chiabu.2012.07.003. Epub 2012 Sep 4.
Results Reference
background
PubMed Identifier
28130787
Citation
Lynoe N, Elinder G, Hallberg B, Rosen M, Sundgren P, Eriksson A. Insufficient evidence for 'shaken baby syndrome' - a systematic review. Acta Paediatr. 2017 Jul;106(7):1021-1027. doi: 10.1111/apa.13760. Epub 2017 Mar 1.
Results Reference
background
PubMed Identifier
21947257
Citation
Squier W. The "Shaken Baby" syndrome: pathology and mechanisms. Acta Neuropathol. 2011 Nov;122(5):519-42. doi: 10.1007/s00401-011-0875-2. Epub 2011 Sep 24.
Results Reference
background
PubMed Identifier
27458075
Citation
Narang SK, Estrada C, Greenberg S, Lindberg D. Acceptance of Shaken Baby Syndrome and Abusive Head Trauma as Medical Diagnoses. J Pediatr. 2016 Oct;177:273-278. doi: 10.1016/j.jpeds.2016.06.036. Epub 2016 Jul 22.
Results Reference
background
PubMed Identifier
35118794
Citation
Kaya A, Celik D, Efe E. The effect of a shaken baby syndrome prevention program on Turkish mothers' awareness and knowledge: A randomized controlled study. J Spec Pediatr Nurs. 2022 Apr;27(2):e12369. doi: 10.1111/jspn.12369. Epub 2022 Feb 3.
Results Reference
derived

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The Effect of a Shaken Baby Syndrome Prevention Program

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