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

Swaddling is a commonly used infant care practice that may promote sleep and soothing when performed using safe techniques. However, inappropriate swaddling practices may restrict hip movement, contribute to overheating, or compromise safe sleep practices. Therefore, this study will compare two swaddling techniques designed to maintain infant safety while differing in positioning: hip-healthy swaddling and midline flexion swaddling.

This study is designed as a three-arm randomized controlled trial involving mothers and their infants aged 1-4 months attending the pediatric outpatient clinics of Izmir University of Economics Medical Point Hospital. A total of 96 mother-infant dyads are planned to be enrolled, with 32 dyads assigned to each group. Participants will be allocated to the hip-healthy swaddling group, midline flexion swaddling group, or control group using stratified block randomization according to infant age and sex.

In the hip-healthy swaddling group, mothers will be taught a swaddling technique that allows sufficient space for flexion and movement of the hips and knees while securely wrapping the upper body. In the midline flexion swaddling group, mothers will be taught a technique in which the infant's upper extremities are maintained close to the midline in a flexed position while the hips and knees remain flexed and sufficiently free to move. Both techniques will follow safe swaddling principles, including placing the infant supine, keeping the face and head uncovered, avoiding excessive tightness and overheating, and discontinuing swaddling when the infant shows signs of attempting to roll. The control group will continue routine infant care without a study-assigned swaddling intervention.

Mothers in both intervention groups will receive face-to-face instruction, an educational brochure, and an instructional video for the assigned technique. The intervention will be implemented for four weeks. Mothers will be contacted at least weekly during the intervention period to support adherence and safe implementation of the assigned technique.

Infant sleep and crying durations will be monitored daily throughout the four-week study period using standardized recording forms and stopwatches provided by the researchers. Maternal comfort will be evaluated using the General Comfort Questionnaire-Short Form at baseline and at the end of the intervention. Infant body weight, length, and head circumference will be measured at baseline and at the end of the four-week follow-up as secondary outcomes.

The primary comparison will evaluate differences among the three study groups in infant sleep duration, infant crying duration, and maternal comfort over the study period. Secondary analyses will evaluate changes in infant growth parameters.

• Hip-Healthy Swaddling (Behavioral): 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 (Behavioral): 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.

Primary outcomes

• 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.

Secondary outcomes

• Change in Infant Body Weight [Baseline and at the end of week 4]: 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 [Baseline and at the end of week 4]: 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 [Baseline and at the end of week 4]: 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.

Sex: All, ages: 1 Month to 4 Months

Inclusion Criteria:

* 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.
* Mothers without a diagnosed physical or mental health condition severe enough to interfere with the daily care of their infant.
* Mothers who provide written informed consent for participation.
* Mothers who are able to speak and understand Turkish.

Exclusion Criteria:

* 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.

• Bahise Aydın, PhD, Principal investigator, İzmir University of Economics