The Effect of a Shaken Baby Syndrome Prevention Program

NCT04568538 | Completed

• 1 other identifier: AkdenizUnv
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Shaken Baby Syndrome; Mothers

Keywords

awareness; knowledge; mothers; nursing; shaken baby syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  2-4 months

Study Arms (2)

İntervention group

EXPERIMENTAL

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.

Other: Training program

Control group

NO INTERVENTION

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.

Interventions

Training program OTHER

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.

İntervention group

Eligibility Criteria

• Age: 2 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, 07058, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 27163220 BACKGROUND

• 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.

  PMID: 21940233 BACKGROUND

• 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.

  PMID: 22954642 BACKGROUND

• 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.

  PMID: 28130787 BACKGROUND

• 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.

  PMID: 21947257 BACKGROUND

• 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.

  PMID: 27458075 BACKGROUND

• 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.

  PMID: 35118794 DERIVED

MeSH Terms

Conditions

Shaken Baby Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Ayla KAYA, Dr.

  Akdeniz University, Faculty of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Dr.

Model Details: Single-blind randomized controlled study

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 29, 2020
• Study Start: January 20, 2019
• Primary Completion: September 20, 2020
• Study Completion: February 20, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)