Infant Sleep and CryingNCT07868380
Effects of Two Swaddling Techniques on Infant Sleep, Crying, and Maternal Comfort
A study testing Hip-Healthy Swaddling and Midline Flexion Swaddling in people with Infant Sleep and Crying, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 4 months
- Conditions the study is for
- Infant Sleep and Crying
- What is being tested?
- Hip-Healthy Swaddling and Midline Flexion Swaddling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir University of Economics Medical Point Hospital
Cordaleo, İzmir, 35575
Bahise Aydın, PhD, +905555210896, bahise.aydin@ieu.edu.tr
Bahise Aydın, PhD
About this 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Infant Sleep and Crying
- Being tested
- Hip-Healthy Swaddling, Midline Flexion Swaddling
- Keywords
- Swaddling, Infant Sleep, Infant Crying, Maternal Comfort, Infant Care, Hip-Healthy Swaddling, Midline Flexion Swaddling
- Medical subject headings
- Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip-Healthy SwaddlingBehavioural
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 SwaddlingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Hip-Healthy Swaddling | Experimental | 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. Receives: Behavioral: Hip-Healthy Swaddling |
| Midline Flexion Swaddling | Experimental | 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. Receives: Behavioral: Midline Flexion Swaddling |
| Routine Care Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and at the end of week 4
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and at the end of week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Sleep and CryingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel randomized controlled trial with two intervention groups and one control group. Participants will be stratified by infant age (1-2 months and 3-4 months) and sex, followed by block randomization within each stratum.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Bahise Aydın, Izmir University of Economics
- Investigators
- Bahise Aydın, PhD, Principal investigator, İzmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868380
- Sponsor's protocol ID
- IEU-SBEK-2026-124099
- Other IDs
- 1919B012556799
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07868380
- Acronym / sponsor ID
- IEU-SBEK-2026-124099
- Conditions
- Infant Sleep and Crying
- Keywords
- Swaddling, Infant Sleep, Infant Crying, Maternal Comfort, Infant Care, Hip-Healthy Swaddling, Midline Flexion Swaddling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm parallel randomized controlled trial with two intervention groups and one control group. Participants will be stratified by infant age (1-2 months and 3-4 months) and sex, followed by block randomization within each stratum.
| Arm | Type | Receives |
|---|---|---|
| Hip-Healthy Swaddling | Experimental | Behavioral: Hip-Healthy SwaddlingMothers 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. |
| Midline Flexion Swaddling | Experimental | Behavioral: Midline Flexion SwaddlingMothers 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. |
| Routine Care Control | No intervention | –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. |
Who may qualify
- Ages
- 1 month to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip-Healthy SwaddlingMothers 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. | Behavioural | Hip-Healthy Swaddling |
| Midline Flexion SwaddlingMothers 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. | Behavioural | Midline Flexion Swaddling |
Primary outcome
Infant Sleep Duration
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in Infant Body Weight
Time frame: Baseline and at the end of week 4
Change in Infant Length
Time frame: Baseline and at the end of week 4
Change in Infant Head Circumference
Time frame: Baseline and at the end of week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bahise Aydın, PhD principal investigator
İzmir University of Economics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip-Healthy Swaddling and Midline Flexion Swaddling in people with Infant Sleep and Crying, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bahise Aydın, PhD (05555210896, bahise.aydin@ieu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Sleep Duration (time frame: Daily for 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.