Sudden Infant DeathSIDSNCT06922682
Training About Sudden Infant Death Syndrome
A study testing Training with Sudden Infant Death Syndrome Training Booklet in people with Sudden Infant Death, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. The study aims examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sudden Infant Death
- What is being tested?
- Training with Sudden Infant Death Syndrome Training Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 Jul 2024
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who were in the 38th week of their pregnancy and older,
- Lived a healthy pregnancy,
- Had no communication problems,
- Can speak and understand Turkish,
- Agreed to participate in the study were included.
Who cannot join
- Pregnant women who were earlier than 38 weeks pregnant,
- Had difficulty in communicating,
- Were illiterate and unable to speak Turkish,
- Who filled out the forms incompletely were not included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Gynecology and Children's Diseases Hospital in Turkey
Samsun, Black Sea Zone, 55100
About this study
Official title: The Effect of Providing Pregnant Women Training on Sudden Infant Death Syndrome (SIDS) on the Post-Partum Risky Behaviors: Randomized Controlled Trial
Sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. The study aims examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge level and behaviors of mothers.
Read the detailed description
Sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. To examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge level and behaviors of mothers. Pre-test post-test designed, randomized controlled, experimental study was conducted in Turkey, 2024. Sixty pregnant women were employed in intervention and control groups. Face-to-face training on risk factors triggering sudden infant death syndrome was provided to pregnant women in intervention group. Study data were collected using "Personal Information Form, Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire". Data were collected face to face before training and after training and via telephone 2 months after training.
- Conditions
- Sudden Infant Death
- Being tested
- Training with Sudden Infant Death Syndrome Training Booklet
- Keywords
- Sudden Infant Death, newborn, mother, risk factors
- 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.
Training with Sudden Infant Death Syndrome Training BookletBehavioural
Sudden Infant Death Syndrome Training Booklet was prepared. Prgenant women who agreed to participate were provided a face-to-face training on the risk factors triggering sudden infant death syndrome through the booklet. Following the educational session, they received the safe sleep handout to use at home and were informed that the researcher would call them two months later to check on their adherence to safe sleep practices. Following the training, participants were re-administered the Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire and the training booklet was given to them as a gift. Two months after the training, the pregnant women were contacted via phone and they were required to fill out the Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire once again.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Pregnant women in their 38th week of pregnancy and later, who visited the hospital to have their NST scans, were then invited to the training with the Risk Factors Triggering Sudden Infant Death Syndrome Training Booklet Receives: Behavioral: Training with Sudden Infant Death Syndrome Training Booklet |
| Control Group | No intervention | Pregnant women in this group were not provided a specific training on the risk factors triggering sudden infant death syndrome. The clinic has already offered a pregnancy school where routine prenatal care training is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Level on SID Identification Questionnaire
Questionnaire, developed by authors consists of 2 sections. First section aims to determine knowledge level of pregnant women about sudden infant death syndrome. Questionnaire consisting of 17 questions are answered as true, false, or I do not know. Items answered as "True" are scored 1 point, whereas items answered as "False" or "I don't know" are scored as 0. Questionnaire includes reverse coded items. The lowest possible score in the questionnaire is 0 and the highest possible score is 17. The second section consists of questions aiming to determine the risky behaviors of pregnant women that may cause sudden infant death syndrome. A total of 26 questions in this section are answered as never (1 point), rarely (2 points), sometimes (3 points), often (4 points) and always (5 points). The questionnaire includes reverse coded items; the lowest and the highest possible scores in the questionnaire are 26 and 130, respectively.
Measured: 20 minutes before training, just after training and 2 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Apr 2024
- Primary completion1 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- a parallel group, randomized, controlled experimental study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Uzşen, Ondokuz Mayıs University
- Investigators
- Hatice Uzsen, PHD, Principal investigator, Ondokuz Mayis Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922682
- Sponsor's protocol ID
- 2023/124
- Acronym
- SIDS
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Providing Pregnant Women Training on Sudden Infant Death Syndrome (SIDS) on the Post-Partum Risky Behaviors: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06922682
- Acronym / sponsor ID
- SIDS / 2023/124
- Conditions
- Sudden Infant Death
- Keywords
- Sudden Infant Death, newborn, mother, risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 10 Apr 2025 (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, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. The study aims examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge level and behaviors of mothers.
Detailed description
Sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. To examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge level and behaviors of mothers. Pre-test post-test designed, randomized controlled, experimental study was conducted in Turkey, 2024. Sixty pregnant women were employed in intervention and control groups. Face-to-face training on risk factors triggering sudden infant death syndrome was provided to pregnant women in intervention group. Study data were collected using "Personal Information Form, Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire". Data were collected face to face before training and after training and via telephone 2 months after training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a parallel group, randomized, controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Training with Sudden Infant Death Syndrome Training BookletPregnant women in their 38th week of pregnancy and later, who visited the hospital to have their NST scans, were then invited to the training with the Risk Factors Triggering Sudden Infant Death Syndrome Training Booklet |
| Control Group | No intervention | –Pregnant women in this group were not provided a specific training on the risk factors triggering sudden infant death syndrome. The clinic has already offered a pregnancy school where routine prenatal care training is provided. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women who were in the 38th week of their pregnancy and older,
- Lived a healthy pregnancy,
- Had no communication problems,
- Can speak and understand Turkish,
- Agreed to participate in the study were included.
Key exclusion criteria (4 listed)
- Pregnant women who were earlier than 38 weeks pregnant,
- Had difficulty in communicating,
- Were illiterate and unable to speak Turkish,
- Who filled out the forms incompletely were not included.
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 with Sudden Infant Death Syndrome Training BookletSudden Infant Death Syndrome Training Booklet was prepared. Prgenant women who agreed to participate were provided a face-to-face training on the risk factors triggering sudden infant death syndrome through the booklet. Following the educational session, they received the safe sleep handout to use at home and were informed that the researcher would call them two months later to check on their adherence to safe sleep practices. Following the training, participants were re-administered the Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire and the training booklet was given to them as a gift. Two months after the training, the pregnant women were contacted via phone and they were required to fill out the Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire once again. | Behavioural | Intervention Group |
Primary outcome
Knowledge Level on SID Identification Questionnaire
Time frame: 20 minutes before training, just after training and 2 month later
Questionnaire, developed by authors consists of 2 sections. First section aims to determine knowledge level of pregnant women about sudden infant death syndrome. Questionnaire consisting of 17 questions are answered as true, false, or I do not know. Items answered as "True" are scored 1 point, whereas items answered as "False" or "I don't know" are scored as 0. Questionnaire includes reverse coded items. The lowest possible score in the questionnaire is 0 and the highest possible score is 17. The second section consists of questions aiming to determine the risky behaviors of pregnant women that may cause sudden infant death syndrome. A total of 26 questions in this section are answered as never (1 point), rarely (2 points), sometimes (3 points), often (4 points) and always (5 points). The questionnaire includes reverse coded items; the lowest and the highest possible scores in the questionnaire are 26 and 130, respectively.
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 22 Sep 2026.
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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.
Hatice Uzsen, PHD principal investigator
Ondokuz Mayis Univeristy
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 with Sudden Infant Death Syndrome Training Booklet in people with Sudden Infant Death, run by Ondokuz Mayıs 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 5 inclusion and 4 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 22 Sep 2026. 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?
Knowledge Level on SID Identification Questionnaire (time frame: 20 minutes before training, just after training and 2 month later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.