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The Effect of a Shaken Baby Syndrome Prevention Program

Mothers Clinical Trial

Official title:
The Effect of a Shaken Baby Syndrome Prevention Program on Turkish Mothers' Awareness and Knowledge: A Randomized Controlled Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04568538
Study type Interventional
Source Akdeniz University
Contact
Status Completed
Phase N/A
Start date January 20, 2019
Completion date February 20, 2021
View Details
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