Implementation of Safe Sleep Practice Recommendations for Infants in Inpatient Wards.
Mrouge Sobaihi, Maysaa A Banjari, Turki S Alahmadi
https://pubmed.ncbi.nlm.nih.gov/33251063Actively Recruiting
Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID06750796
The Effect of Half Swaddling on Infant Sleep, Maternal Sleep Quality, and Postpartum Depression in Term Infants
Led by Tanta University · Updated on 2024-12-27
128
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how half swaddling affects infant sleep routines, maternal sleep quality, and postpartum depression in full-term newborns. This prospective controlled study involves mothers and their babies, aiming to understand if gently wrapping infants in a way that mimics the womb impacts these important outcomes during the first three months after birth. The study includes two groups: one receiving the half swaddling intervention and a control group. Half swaddling involves wrapping the baby with soft fabric without restricting arm and leg movement, applied 15 minutes before each daytime sleep from birth to three months. A total of 128 mother-infant pairs are randomly assigned equally to either the half swaddling group or the control group. Participants will be followed up through telephone interviews at birth, and monthly for three months. Researchers will assess infant sleep routines using questionnaires and measure maternal sleep quality and postpartum depression with validated scales. This allows close monitoring of effects during the postpartum period to better understand the impact of half swaddling on both infants and mothers.
CONDITIONS
Official Title
The Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality, Depression
Who Can Participate
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 years old
- Term birth of a single baby over 37 weeks
- Uncomplicated pregnancy with delivery by normal vaginal or cesarean method
- No use of cigarettes, alcohol, or stimulants
- Body mass index less than 30
- Not working night shifts
- Stable vital signs
- No history of infertility treatment
- No chronic diseases such as hypertension or diabetes
- No serious depression, anxiety, or stress
- No cognitive impairment conditions like delirium, dementia, or intellectual retardation
- No serious maternal complications
- Mothers must volunteer to participate
- Baby birth weight over 2500 grams
- Baby with stable vital signs
- Baby APGAR score above 7
- No serious neonatal complications
- Baby without congenital malformations
You will not qualify if you...
- Under 18 years old
- Preterm birth under 37 weeks or multiple births
- Complicated pregnancy with incomplete delivery by vaginal or cesarean method
- Use of cigarettes, alcohol, or stimulants
- Body mass index over 30
- Working night shifts
- Unstable vital signs
- History of infertility treatment
- Chronic diseases such as hypertension or diabetes
- Severe depression, anxiety, or stress
- Cognitive impairment conditions like delirium, dementia, or intellectual retardation
- Serious maternal complications
- Mothers who do not volunteer to participate
- Baby birth weight 2500 grams or below
- Baby with unstable vital signs
- Baby APGAR score below 7
- Serious neonatal complications
- Baby with congenital malformations
AI-Screening
AI-Powered Screening
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1
2
3
Trial Site Locations
Total: 1 location
1
Trakya University
Edirne, None Selected, Turkey (Türkiye), 22030
Actively Recruiting
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Research Team
H
Hatice Kahyaoglu Sut, 1.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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