Clinical trial NCT06750796: The Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality, Depression
Official title: The Effect of Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality and Postpartum Depression in Term Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant, Newborn
Maternal Outcome
Keywords: Infant
half swaddling
maternal sleep quality
postpartum depression
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd months
timeFrame: Postpartum first 3 months
measure: Pittsburgh Sleep Quality Index
timeFrame: up to 3 months
measure: Edinburgh Postnatal Depression Scale
timeFrame: up to 3 months
measure: Short Infant Sleep Routine Questionnaire
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
state: None Selected
Study officials:
References:
citation: Sobaihi M, Banjari MA, Alahmadi TS. Implementation of Safe Sleep Practice Recommendations for Infants in Inpatient Wards. Cureus. 2020 Oct 25;12(10):e11155. doi: 10.7759/cureus.11155.