- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06922682
Training About Sudden Infant Death Syndrome (SIDS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Black Sea Zone
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Samsun, Black Sea Zone, Turkey (Türkiye), 55100
- Samsun Gynecology and Children's Diseases Hospital in Turkey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
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 |
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. |
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No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Knowledge Level on SID Identification Questionnaire
Time Frame: 20 minutes before training, just after training and 2 month later
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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. |
20 minutes before training, just after training and 2 month later
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hatice Uzsen, PHD, Ondokuz Mayis Univeristy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/124
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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