Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04568538
Status:
COMPLETED
Last Update Posted:
2021-12-17
First Post:
2020-09-17
Brief Title:
The Effect of a Shaken Baby Syndrome Prevention Program
Sponsor:
Akdeniz University
Organization:
Akdeniz University
Study Overview
Official Title:
The Effect of a Shaken Baby Syndrome Prevention Program on Turkish Mothers Awareness and Knowledge A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 230 and statistical significance will be set at p 005
Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University
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 230 and statistical significance will be set at p 005
Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None