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

NCT06750796 | Recruiting

• 1 other identifier: Prospective controlled study
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Newborn; Maternal Outcome

Keywords

Infant; half swaddling; maternal sleep quality; postpartum depression

Outcome Measures

Primary Outcomes (4)

• Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd months

  Postpartum first 3 months

• Pittsburgh Sleep Quality Index

  up to 3 months

• Edinburgh Postnatal Depression Scale

  up to 3 months

• Short Infant Sleep Routine Questionnaire

  up to 3 months

Study Arms (1)

Control group

OTHER

The group that will not be treated with half swaddling

Behavioral: The Half Swaddling Application

Interventions

The Half Swaddling Application BEHAVIORAL

Half swaddling application in term babies

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Postpartum mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Trakya University

Edirne, None Selected, 22030, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 33251063 BACKGROUND

Related Links

• Swaddling: Is it Safe for Your Baby?

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Hatice Kahyaoglu Sut, 1.

CONTACT

05337662979; haticesut@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 27, 2024
• Study Start: May 18, 2023
• Primary Completion: June 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)