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.
Infants aged 1-4 months and their mothers.
Infants receiving outpatient care at the pediatric outpatient clinic.
Infants without anatomical, physiological, or developmental health conditions that would contraindicate swaddling, including developmental dysplasia of the hip, cardiopulmonary disorders, musculoskeletal disorders, or neurological disorders.
Infants who have not yet developed the ability to roll from the supine position to either side or to the prone position.
Infants who, during the study, are diagnosed with a condition for which swaddling is contraindicated and who subsequently require pharmacological or physical treatment related to that condition.
Mothers who, during the study, begin pharmacological treatment with analgesic or sedative medications that may affect comfort.
Parallel
Hip-Healthy Swaddling
BehavioralMothers 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
BehavioralMothers 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.
Infant Sleep Duration
Infant sleep duration will be recorded daily by mothers using a standardized sleep monitoring form and a stopwatch provided by the researchers. Mothers will start the stopwatch when the infant falls asleep and stop it when the infant wakes. Sleep duration will be recorded in minutes for each sleep episode, and daily total sleep duration will be calculated. Daily sleep durations will be recorded throughout the four-week follow-up period and summarized for analysis.
Infant Crying Duration
Infant crying duration will be recorded daily by mothers using a standardized crying monitoring form and a stopwatch provided by the researchers. Mothers will start the stopwatch at the beginning of a crying episode and stop it when the crying episode ends. Crying duration will be recorded in minutes for each crying episode, and daily total crying duration will be calculated. Daily crying durations will be recorded throughout the four-week follow-up period and summarized for analysis.
Maternal Comfort
Maternal comfort will be assessed using the General Comfort Questionnaire-Short Form. The scale consists of 28 items assessing relief, ease, and transcendence. After reverse coding negatively worded items, item scores are summed and divided by the number of items to obtain a mean score. Scores range from 1 to 6, with higher scores indicating a higher level of comfort.
Change in Infant Body Weight
Infant body weight will be measured using the same calibrated infant scale by the same researcher at baseline and at the end of the four-week follow-up. Body weight will be recorded in grams. Change in body weight from baseline to week 4 will be evaluated.
Change in Infant Length
Infant length will be measured using the same infant length measurement equipment by the same researcher at baseline and at the end of the four-week follow-up. Length will be recorded in centimeters. Change in length from baseline to week 4 will be evaluated.
Change in Infant Head Circumference
Infant head circumference will be measured using the same non-stretchable measuring tape by the same researcher at baseline and at the end of the four-week follow-up. Head circumference will be recorded in centimeters. Change in head circumference from baseline to week 4 will be evaluated.
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Izmir University of Economics
Lead sponsor
The Scientific and Technological Research Council of Turkey
Collaborator
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