An interventional study of Hip-Healthy Swaddling and Midline Flexion Swaddling in Infant Sleep and Crying, sponsored by Izmir University of Economics. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 1 Month to 4 Months. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Izmir University of Economics · Not applicable, Interventional, and Supportive care
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:
Mothers and infants participating in the study will:
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.
39 studies on the registry are indexed under Crying; 8 are open to participants now.
This study's planned enrollment of 96 is close to the median of 90 across 34 interventional studies indexed under Crying.
Browse Crying studies →Izmir University of Economics is the lead sponsor of 22 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mothers assigned to this group will receive face-to-face training on hip-healthy swaddling, supported by an educational brochure and instructional video. The technique securely wraps the infant's upper body while allowing sufficient space for the hips and knees to remain flexed and move freely. Mothers will use the assigned swaddling technique as part of the infant's sleep routine for four weeks.
Behavioral: Hip-Healthy Swaddling
Mothers assigned to this group will receive face-to-face training on midline flexion swaddling, supported by an educational brochure and instructional video. The technique maintains the infant's upper extremities close to the midline in a flexed position while allowing the hips and knees to remain flexed and sufficiently free to move. Mothers will use the assigned swaddling technique as part of the infant's sleep routine for four weeks.
Behavioral: Midline Flexion Swaddling
Mother-infant dyads assigned to the control group will continue their routine infant care practices and will not receive a study-assigned swaddling intervention during the four-week study period.
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.
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.
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.
Time frame: Daily for 4 weeks
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.
Time frame: Daily for 4 weeks
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.
Time frame: Baseline and at the end of week 4
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.
Time frame: Baseline and at the end of week 4
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.
Time frame: Baseline and at the end of week 4
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.
Time frame: Baseline and at the end of week 4
Plan to share: No — Individual participant data (IPD) will not be shared because the approved study protocol and informed consent procedures do not include sharing participant-level data with researchers outside the study team. Study findings will be reported only in aggregate form to protect participant confidentiality and privacy.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
Of 15 interventional studies with no phase under Crying, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 10 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Izmir University of Economics