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The Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality, Depression

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06750796
Acronym
Half swaddling
Enrollment
128
Registered
2024-12-27
Start date
2023-05-18
Completion date
2025-12-15
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Newborn, Maternal Outcome

Keywords

Infant, half swaddling, maternal sleep quality, postpartum depression

Brief summary

In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression.

Detailed description

In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression. half swaddling; Half swaddling applied to a newborn baby makes the baby feel completely safe as if they are still in the womb. After laying the soft fabric or baby blanket, it will be placed in the supine position. It is swaddling in a way that does not restrict the movement of the baby's arms and legs too much. n=128 (64=control, 64=half swaddling group) mothers and babies who volunteered to participate in the study will be randomized into two groups as case and control. In the half stock group; From the 1st to the 3rd month, half swaddling will be done 15 minutes before each sleep during the day. 0 (first meeting), 1, 2 and 3 months will be interviewed by phone for follow-up purposes.

Interventions

BEHAVIORALThe Half Swaddling Application

Half swaddling application in term babies

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

In this study, n=128 (64=control, 64=half swaddling group) mothers and infants who volunteered to participate in the study will be conducted in two groups as case and control, randomly.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd monthsPostpartum first 3 months
Pittsburgh Sleep Quality Indexup to 3 months
Edinburgh Postnatal Depression Scaleup to 3 months
Short Infant Sleep Routine Questionnaireup to 3 months

Countries

Turkey (Türkiye)

Contacts

Primary ContactHatice Kahyaoglu Sut, 1.
haticesut@yahoo.com05337662979

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026