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

NCT07868380 | Not Yet Recruiting

• 2 other identifiers: IEU-SBEK-2026-1240991919B012556799
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant Sleep and Crying

Keywords

Swaddling; Infant Sleep; Infant Crying; Maternal Comfort; Infant Care; Hip-Healthy Swaddling; Midline Flexion Swaddling

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and at the end of week 4

Secondary Outcomes (3)

• Change in Infant Body Weight

  Baseline and at the end of week 4

• Change in Infant Length

  Baseline and at the end of week 4

• Change in Infant Head Circumference

  Baseline and at the end of week 4

Study Arms (3)

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.

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.

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.

Interventions

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.

Hip-Healthy Swaddling

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.

Midline Flexion Swaddling

Eligibility Criteria

• Age: 1 Month - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir University of Economics: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Izmir University of Economics Medical Point Hospital

Cordaleo, İzmir, 35575, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Crying

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Study Officials

• Bahise Aydın, PhD

  İzmir University of Economics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bahise Aydın, PhD

CONTACT

05555210896; bahise.aydin@ieu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the behavioral intervention, mothers and researchers providing the swaddling education cannot be blinded to group assignment. Study groups will be coded as A, B, and C for statistical analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatric Nursing

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)