Shaken Baby SyndromeNCT04568538
The Effect of a Shaken Baby Syndrome Prevention Program
A study testing Training program in people with Shaken Baby Syndrome and Mothers, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 2 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Shaken Baby Syndrome, Mothers
- What is being tested?
- Training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2019to 20 Feb 2021
- 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 2 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having a baby of 2-4 months, Free from physical or mental disability
Who cannot join
- Unhealthy (mother or baby), Any SBS education in the last 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Shaken Baby Syndrome Prevention Program on Turkish Mothers' Awareness and Knowledge: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Shaken Baby Syndrome, Mothers
- Being tested
- Training program
- Keywords
- awareness, knowledge, mothers, nursing, shaken baby syndrome
- Medical subject headings
- Shaken Baby Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start20 Jan 2019
- Primary completion20 Sep 2020
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Shaken Baby SyndromeStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Single-blind randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayla Kaya, Akdeniz University
- Investigators
- Ayla KAYA, Dr., Study director, Akdeniz University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568538
- Sponsor's protocol ID
- AkdenizUnv
- Status last verified
- Dec 2021
- First submitted
- 17 Sep 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27163220Bechtel 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.
PubMed 21940233Fujiwara 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.
PubMed 22954642Lynoe 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.
PubMed 28130787Squier 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.
PubMed 21947257Narang 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.
PubMed 27458075Kaya 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.
PubMed 35118794
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Shaken Baby Syndrome Prevention Program on Turkish Mothers' Awareness and Knowledge: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04568538
- Acronym / sponsor ID
- AkdenizUnv
- Conditions
- Shaken Baby Syndrome, Mothers
- Keywords
- awareness, knowledge, mothers, nursing, shaken baby syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 29 Sep 2020 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Other: Training programRandomization 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. |
| 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. |
Who may qualify
- Ages
- 2 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Having a baby of 2-4 months, Free from physical or mental disability
Key exclusion criteria (1 listed)
- Unhealthy (mother or baby), Any SBS education in the last 2 years
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 |
|---|---|---|
| Training programA 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. | Other | İntervention group |
Primary outcome
Shaken baby syndrome knowledge level
Time frame: 2-4 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Background: PubMed 27163220Rideout 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.
- Background: PubMed 21940233Bechtel 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.
- Background: PubMed 22954642Fujiwara 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.
- Background: PubMed 28130787Lynoe 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.
- Background: PubMed 21947257Squier 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.
- Background: PubMed 27458075Narang 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.
- Derived from this study: PubMed 35118794Kaya 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.
- Individual participant dataSharing planned: No
Related trials for Shaken Baby Syndrome
Not yet recruiting
The Impact of the Nurse-Led "My Baby is Safe" Educational Program
Sudden Infant Death Syndrome, Shaken Baby Syndrome
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.
Ayla KAYA, Dr. study director
Akdeniz University, Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training program in people with Shaken Baby Syndrome and Mothers, run by Akdeniz University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 17 Dec 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shaken baby syndrome knowledge level (time frame: 2-4 months). 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 NCT04568538, which also lists 7 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 17 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.