Clinical Research Directory
Browse clinical research sites, groups, and studies.
Effects of Two Swaddling Techniques on Infant Sleep, Crying, and Maternal Comfort
Sponsor: Izmir University of Economics
Summary
The goal of this clinical trial is to learn how two different safe swaddling techniques affect sleep duration, crying duration, and maternal comfort in infants aged 1-4 months and their mothers. The main questions it aims to answer are: * Do hip-healthy swaddling and midline flexion swaddling affect infants' sleep duration compared with routine care without a study-assigned swaddling intervention? * Do hip-healthy swaddling and midline flexion swaddling affect infants' crying duration compared with routine care without a study-assigned swaddling intervention? * Do the two swaddling techniques affect mothers' comfort levels compared with routine care? Researchers will compare three groups: hip-healthy swaddling, midline flexion swaddling, and a control group receiving routine care without a study-assigned swaddling intervention. This will help determine whether the two swaddling techniques have different effects on infant sleep and crying duration and maternal comfort. Mothers and infants participating in the study will: * Be randomly assigned to one of the three study groups. * Receive face-to-face training, an educational brochure, and an instructional video on the assigned swaddling technique if allocated to one of the two swaddling groups. * Follow the assigned swaddling technique as part of the infant's sleep routine for four weeks if allocated to a swaddling group. * Record the infant's sleep and crying durations daily for four weeks using a stopwatch and monitoring forms provided by the researchers. * Complete an assessment of maternal comfort at the beginning and end of the study. * Have the infant's body weight, length, and head circumference measured at the beginning and end of the study.
Official title: Effects of Two Different Swaddling Techniques on Sleep and Crying Duration in Infants Aged 1-4 Months and Maternal Comfort: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
1 Month - 4 Months
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2026-10
Completion Date
2027-08
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Hip-Healthy Swaddling
Mothers assigned to this intervention will receive face-to-face training on hip-healthy swaddling, supported by an educational brochure and instructional video. The infant will be placed supine and the upper body will be securely wrapped, while sufficient space will be maintained around the hips and legs to allow hip abduction and flexion, knee flexion, and free movement of the lower extremities. The swaddle will allow approximately two-finger space at the chest, and the infant's face and head will remain uncovered. Mothers will apply the technique as part of the infant's sleep routine for four weeks. Safe swaddling principles, including avoiding excessive tightness and overheating, will be followed.
Midline Flexion Swaddling
Mothers assigned to this intervention will receive face-to-face training on midline flexion swaddling, supported by an educational brochure and instructional video. The infant will be placed supine, with the upper extremities maintained close to the midline in a flexed position. The hips and knees will remain flexed with sufficient space for free movement of the lower extremities. The swaddle will allow approximately two-finger space at the chest, and the infant's face and head will remain uncovered. Mothers will apply the technique as part of the infant's sleep routine for four weeks. Safe swaddling principles, including avoiding excessive tightness and overheating, will be followed.
Locations (1)
Izmir University of Economics Medical Point Hospital
Cordaleo, İzmir, Turkey (Türkiye)