Sudden Infant DeathNCT05823051
The Effect of Video-Assisted Sudden Infant Death Syndrome Prevention Training Program and Counseling Practice on Mothers' Knowledge Level and Self-efficacy: Randomized Controlled Study
A study testing VASIDS-TP and Counseling Practice in people with Sudden Infant Death, run by Dilara Aydin Tozlu.
Trial summary
Sudden Infant Death Syndrome (SIDS) is one of the leading causes of infant mortality in the postneonatal period, but it can be prevented and its incidence can be reduced by creating a safe sleep environment with modifiable risk factors. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sudden Infant Death
- What is being tested?
- VASIDS-TP and Counseling Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 15 Nov 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The one who has just given birth,
- With a healthy newborn baby,
- Speaks, understands and can read and write Turkish and has no barriers to communication,
- Able to use the internet, telephone and e-mail actively,
- Mothers who voluntarily agreed to participate in the study will be included.
Who cannot join
- Have not attended at least 3 sessions of the training program,
- Mothers who indicate that they want to leave the study while the research is ongoing will be excluded.
Trial locations and contacts
No sites are listed yet.
Dilara AYDIN TOZLU, Master's degree contact
About this study
Official title: Akdeniz University
Sudden Infant Death Syndrome (SIDS) is one of the leading causes of infant mortality in the postneonatal period, but it can be prevented and its incidence can be reduced by creating a safe sleep environment with modifiable risk factors. It is known that parents, infant care providers and healthcare professionals do not have sufficient knowledge about SIDS and safe sleep, and especially mothers exhibit many risky behaviors in terms of SIDS, such as using the wrong sleeping positions while putting their babies to sleep. Therefore, it is of critical importance to inform and raise awareness of parents on the issues of SIDS and safe sleep, which remain important today, on the premise of promoting public health.
Read the detailed description
Sudden Infant Death Syndrome (SIDS) is one of the leading causes of infant mortality in the postneonatal period, but it can be prevented and its incidence can be reduced by creating a safe sleep environment with modifiable risk factors. It is known that parents, infant care providers and health professionals do not have sufficient knowledge about SIDS and safe sleep, and especially mothers exhibit many risky behaviors in terms of SIDS, such as using the wrong sleeping positions while putting their babies to sleep. Therefore, it is of utmost importance to inform and raise awareness of parents on the issues of SIDS and safe sleep, which remain important today, on the premise of promoting public health. In addition, informing mothers about the risk factors to protect their babies from SIDS, encouraging them to create and maintain a safe sleep environment, and ensuring that they are pioneers in this regard are also of great importance in terms of sharing information with other infant care providers in their social life. SIDS occurs in the postpartum period and has high values in infant mortality rates. For this reason, it is predicted that awareness on this issue will be significantly increased by providing education to new mothers at the earliest period and that SIDS can be prevented significantly by providing safe sleep environments. At the same time, based on the effect of self-efficacy perceptions of new mothers on the care of the baby, it is thought that the training and counseling practice planned to be given to mothers about SIDS will have a positive effect on the self-efficacy perceptions of mothers. When the relevant literature was examined, it was found that there were not enough studies on this subject in our country.
The aim of this study was to evaluate the effect of video-assisted Sudden Infant Death Syndrome prevention training program and counseling on mothers' knowledge level and self-efficacy.
- Conditions
- Sudden Infant Death
- Being tested
- VASIDS-TP and Counseling Practice
- Keywords
- Sudden Infant Death Syndrome, Nursing, Parent Education, Educational Program, Prevention
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VASIDS-TP and Counseling PracticeOther
VASIDS-TP will be implemented online as an individual training to the intervention group through the Microsoft Teams program, to be completed in 5 days-5 sessions in the time frames determined by the participants. The consultancy practice will start with a pre-test and participants will be assured that they can call the researcher 24/7, and the consultancy practice will be continued by phone call or messaging.
| Study group | Role | What they receive |
|---|---|---|
| VASIDS-TP and Counseling Practice | Experimental | Video-Assisted Sudden Infant Death Syndrome Prevention Training Program (VASIDS-TP) and Counseling Practice Receives: Other: VASIDS-TP and Counseling Practice |
| Routine Care | No intervention | The control group will receive routine care in the obstetric ward. A pre-test will be conducted using the Google Survey form. "Personal Information Form", "Sudden Infant Death Syndrome Knowledge Level Assessment Form" (Pre-Test) and "General Self-Efficacy Scale" will be completed at this stage. The mothers in the control group will receive the training included in clinical routine care. The mothers in this group will not receive any planned structured training by the researchers during the study. The mothers in the control group will be administered the "Sudden Infant Death Syndrome Knowledge Level Assessment Data Form" and the "General Self-Efficacy Scale" with the Google survey that will be sent to their phones 1 month after the pre-test application. After the completion of the study, the control group will receive the same intervention (VASIDS-TP) as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudden Infant Death Syndrome Knowledge Level Assessment Form 1
This form was developed by the researchers in line with the literature and consists of 33 items to measure the level of knowledge about SIDS.
Measured: Before the training
Sudden Infant Death Syndrome Knowledge Level Assessment Form 2
This form was developed by the researchers in line with the literature and consists of 33 items to measure the level of knowledge about SIDS.
Measured: 1 month after the training
General Self-Efficacy Scale 1
"General Self-Efficacy Scale" is a five-point Likert-type scale consisting of 17 items. The question "How well does it describe you?" has five options ranging from "not at all" to "very well". The total score of the scale ranges between 17-85, and the higher the score, the higher the self-efficacy belief.
Measured: Before the training
General Self-Efficacy Scale 2
"General Self-Efficacy Scale" is a five-point Likert-type scale consisting of 17 items. The question "How well does it describe you?" has five options ranging from "not at all" to "very well". The total score of the scale ranges between 17-85, and the higher the score, the higher the self-efficacy belief.
Measured: 1 month after the training
Secondary outcomes (3)
Personal Information Form
The "Personal Information Form" developed by the researchers in line with the literature includes multiple-choice questions about mother, baby and sleep environment.
Measured: Before the training
DISCERN Scale
The training videos developed by the researchers will be evaluated by experts using DISCERN. Basically, it was developed to assess the quality of written and technology-based educational materials prepared to inform individuals about health and treatment options. The DISCERN scale consists of 16 items and each question is scored from 1 to 5. A score in the range of 15-75 is obtained by summing the responses from each item. In the evaluation, a low total score indicates poor quality and a high score indicates good quality.
Measured: After the training videos are created
System Usability Scale (SUS)
In the test phase of the developed VASIDS-TP, SUS will be applied to evaluate the experiences of mothers (users). The whole scale consists of 10 questions. Each question has a value from 1 to 5 according to the answer given. SUS Score value is obtained between 0-100. SUS Score values of 68 points and above are considered above average, while values below 68 points are considered below average.
Measured: Pre-application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Jul 2023 (estimated)
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sudden Infant DeathStudies of the same condition, open and under way.
- 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
- The study was planned as a randomized controlled, parallel, double centered and double blind study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dilara Aydin Tozlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilara Aydin Tozlu, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823051
- Sponsor's protocol ID
- AUDilaraAT
- Status last verified
- Apr 2023
- First submitted
- 8 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hutton JS, Gupta R, Gruber R, Berndsen J, DeWitt T, Ollberding NJ, Van Ginkel JB, Ammerman RT. Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population. Acad Pediatr. 2017 Nov-Dec;17(8):879-886. doi: 10.1016/j.acap.2017.04.018. Epub 2017 Apr 24.
PubMed 28450082
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Akdeniz University
- ClinicalTrials.gov ID
- NCT05823051
- Acronym / sponsor ID
- AUDilaraAT
- Conditions
- Sudden Infant Death
- Keywords
- Sudden Infant Death Syndrome, Nursing, Parent Education, Educational Program, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dilara Aydin TozluUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 21 Apr 2023 (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.
Sudden Infant Death Syndrome (SIDS) is one of the leading causes of infant mortality in the postneonatal period, but it can be prevented and its incidence can be reduced by creating a safe sleep environment with modifiable risk factors. It is known that parents, infant care providers and healthcare professionals do not have sufficient knowledge about SIDS and safe sleep, and especially mothers exhibit many risky behaviors in terms of SIDS, such as using the wrong sleeping positions while putting their babies to sleep. Therefore, it is of critical importance to inform and raise awareness of parents on the issues of SIDS and safe sleep, which remain important today, on the premise of promoting public health.
Detailed description
Sudden Infant Death Syndrome (SIDS) is one of the leading causes of infant mortality in the postneonatal period, but it can be prevented and its incidence can be reduced by creating a safe sleep environment with modifiable risk factors. It is known that parents, infant care providers and health professionals do not have sufficient knowledge about SIDS and safe sleep, and especially mothers exhibit many risky behaviors in terms of SIDS, such as using the wrong sleeping positions while putting their babies to sleep. Therefore, it is of utmost importance to inform and raise awareness of parents on the issues of SIDS and safe sleep, which remain important today, on the premise of promoting public health. In addition, informing mothers about the risk factors to protect their babies from SIDS, encouraging them to create and maintain a safe sleep environment, and ensuring that they are pioneers in this regard are also of great importance in terms of sharing information with other infant care providers in their social life. SIDS occurs in the postpartum period and has high values in infant mortality rates. For this reason, it is predicted that awareness on this issue will be significantly increased by providing education to new mothers at the earliest period and that SIDS can be prevented significantly by providing safe sleep environments. At the same time, based on the effect of self-efficacy perceptions of new mothers on the care of the baby, it is thought that the training and counseling practice planned to be given to mothers about SIDS will have a positive effect on the self-efficacy perceptions of mothers. When the relevant literature was examined, it was found that there were not enough studies on this subject in our country.
The aim of this study was to evaluate the effect of video-assisted Sudden Infant Death Syndrome prevention training program and counseling on mothers' knowledge level and self-efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned as a randomized controlled, parallel, double centered and double blind study.
| Arm | Type | Receives |
|---|---|---|
| VASIDS-TP and Counseling Practice | Experimental | Other: VASIDS-TP and Counseling PracticeVideo-Assisted Sudden Infant Death Syndrome Prevention Training Program (VASIDS-TP) and Counseling Practice |
| Routine Care | No intervention | –The control group will receive routine care in the obstetric ward. A pre-test will be conducted using the Google Survey form. "Personal Information Form", "Sudden Infant Death Syndrome Knowledge Level Assessment Form" (Pre-Test) and "General Self-Efficacy Scale" will be completed at this stage. The mothers in the control group will receive the training included in clinical routine care. The mothers in this group will not receive any planned structured training by the researchers during the study. The mothers in the control group will be administered the "Sudden Infant Death Syndrome Knowledge Level Assessment Data Form" and the "General Self-Efficacy Scale" with the Google survey that will be sent to their phones 1 month after the pre-test application. After the completion of the study, the control group will receive the same intervention (VASIDS-TP) as the intervention group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The one who has just given birth,
- With a healthy newborn baby,
- Speaks, understands and can read and write Turkish and has no barriers to communication,
- Able to use the internet, telephone and e-mail actively,
- Mothers who voluntarily agreed to participate in the study will be included.
Key exclusion criteria (2 listed)
- Have not attended at least 3 sessions of the training program,
- Mothers who indicate that they want to leave the study while the research is ongoing will be excluded.
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 |
|---|---|---|
| VASIDS-TP and Counseling PracticeVASIDS-TP will be implemented online as an individual training to the intervention group through the Microsoft Teams program, to be completed in 5 days-5 sessions in the time frames determined by the participants. The consultancy practice will start with a pre-test and participants will be assured that they can call the researcher 24/7, and the consultancy practice will be continued by phone call or messaging. | Other | VASIDS-TP and Counseling Practice |
Primary outcome
Sudden Infant Death Syndrome Knowledge Level Assessment Form 1
Time frame: Before the training
This form was developed by the researchers in line with the literature and consists of 33 items to measure the level of knowledge about SIDS.
Sudden Infant Death Syndrome Knowledge Level Assessment Form 2
Time frame: 1 month after the training
This form was developed by the researchers in line with the literature and consists of 33 items to measure the level of knowledge about SIDS.
General Self-Efficacy Scale 1
Time frame: Before the training
"General Self-Efficacy Scale" is a five-point Likert-type scale consisting of 17 items. The question "How well does it describe you?" has five options ranging from "not at all" to "very well". The total score of the scale ranges between 17-85, and the higher the score, the higher the self-efficacy belief.
General Self-Efficacy Scale 2
Time frame: 1 month after the training
"General Self-Efficacy Scale" is a five-point Likert-type scale consisting of 17 items. The question "How well does it describe you?" has five options ranging from "not at all" to "very well". The total score of the scale ranges between 17-85, and the higher the score, the higher the self-efficacy belief.
3 secondary outcomes
Personal Information Form
Time frame: Before the training
DISCERN Scale
Time frame: After the training videos are created
System Usability Scale (SUS)
Time frame: Pre-application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Background: PubMed 28450082Hutton JS, Gupta R, Gruber R, Berndsen J, DeWitt T, Ollberding NJ, Van Ginkel JB, Ammerman RT. Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population. Acad Pediatr. 2017 Nov-Dec;17(8):879-886. doi: 10.1016/j.acap.2017.04.018. Epub 2017 Apr 24.
- Individual participant dataSharing planned: No
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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.
Dilara AYDIN TOZLU, Master's degree contact
Questions about this trial
What is this clinical trial studying?
A study testing VASIDS-TP and Counseling Practice in people with Sudden Infant Death, run by Dilara Aydin Tozlu.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilara AYDIN TOZLU, Master's degree (dilara.aydinn.da@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sudden Infant Death Syndrome Knowledge Level Assessment Form 1 (time frame: Before the training). The study lists 4 primary outcomes in all. 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 NCT05823051, which also lists 1 linked publication.
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 21 Apr 2023.