Effects of half swaddling on infant sleep and maternal well-being

The Effect of Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality and Postpartum Depression in Term Infants

This study is testing if half swaddling can help newborns sleep better and improve the sleep and mental health of their mothers.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Tanta University (other)
• Locations: 1 site (Edirne, None Selected)
• Trial ID: NCT06750796 on ClinicalTrials.gov

What this trial studies

This study investigates how half swaddling affects the sleep routines of term infants and the sleep quality and mental health of their mothers. In a controlled setting, 128 mother-infant pairs will be randomized into two groups: one receiving half swaddling before sleep and a control group. The intervention involves swaddling the infant in a way that allows for some movement, aiming to create a sense of security similar to the womb. Follow-up interviews will be conducted at 1, 2, and 3 months to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are mothers aged 18-45 with term infants who have had uncomplicated pregnancies and meet specific health criteria.

Not a fit: Patients who are under 18, have chronic diseases, or are experiencing serious mental health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve infant sleep patterns and enhance maternal sleep quality, potentially reducing postpartum depression.

How similar studies have performed: While similar approaches to infant sleep interventions have shown promise, this specific method of half swaddling is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 18-45 years old,
* Term birth (single birth over 37 weeks),
* After an uncomplicated pregnancy process, the delivery was completed by normal vaginal or cesarean delivery method,
* Not using cigarettes, alcohol and stimulants,
* BMI\<30,
* Not working on night shift,
* Stable vital signs,
* Those who have not received infertility treatment,
* Do not have a chronic disease (such as hypertension, diabetes mellitus),
* Not experiencing serious depression, anxiety and stress,
* Not having any organic or non-organic disease that can cause cognitive impairment (such as Delirium, Dementia, Intellectual Retardation, etc.),
* No serious maternal complications,
* Mothers who volunteered to participate in the study will be included in the study.

For baby;

* Birth weight over 2500 g,
* Stable vital signs,
* APGAR score above 7,
* No serious neonatal complications,
* Midwives without congenital malformations will be included in the study.

Exclusion Criteria:

* under 18 years old,
* Preterm birth (under 37 weeks and/or multiple births),
* Incomplete delivery by normal vaginal or cesarean delivery method after a complicated pregnancy process,
* Using cigarettes, alcohol and stimulants,
* BMI\>30,
* Working night shift,
* No stable vital signs,
* Having received infertility treatment,
* Having a chronic disease (such as hypertension, diabetes mellitus),
* Experiencing severe depression, anxiety and stress,
* Having any organic or non-organic disease that can cause cognitive impairment (such as Delirium, Dementia, Intellectual Retardation, etc.),
* Serious maternal complication,
* Mothers who do not volunteer to participate in the study will not be included in the study.

For baby;

* Birth weight of 2500 g and below,
* No stable vital signs,
* APGAR score below 7,
* Serious neonatal complication,
* Babies with congenital malformations will not be included in the study.

Where this trial is running

Edirne, None Selected

• Trakya University — Edirne, None Selected, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Hatice Kahyaoglu Sut, 1.

Conditions: Infant, Newborn, Maternal Outcome, Infant, half swaddling, maternal sleep quality, postpartum depression