Effects of Two Swaddling Techniques on Infant Sleep, Crying, and Maternal Comfort

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Infant Sleep Duration — Daily for 4 weeks
  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 — Daily for 4 weeks
  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 — Baseline and at the end of week 4
  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.

Trial sites (1)

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