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

NCT ID: NCT06750796

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-18

Study Completion Date

2025-12-15

Brief Summary

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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

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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.

Conditions

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Infant, Newborn Maternal Outcome

Keywords

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Infant half swaddling maternal sleep quality postpartum depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

The group that will not be treated with half swaddling

Group Type OTHER

The Half Swaddling Application

Intervention Type BEHAVIORAL

Half swaddling application in term babies

Interventions

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The Half Swaddling Application

Half swaddling application in term babies

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Hatice Kahyaoglu Sut

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Trakya University

Edirne, None Selected, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hatice Kahyaoglu Sut, 1.

Role: CONTACT

Phone: 05337662979

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 33251063 (View on PubMed)

Related Links

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https://www.healthychildren.org/English/ages-stages/baby/diapers-clothing/Pages/Swaddling-Is-it-Safe.aspx

Swaddling: Is it Safe for Your Baby?

Other Identifiers

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Prospective controlled study

Identifier Type: -

Identifier Source: org_study_id