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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infant, Newborn; Maternal Outcome
• Intervention / Treatment: Behavioral: The Half Swaddling Application

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hatice Kahyaoglu Sut, 1.; Phone Number: +90 05337662979; Email: haticesut@yahoo.com

Study Locations

• Turkey
  • None Selected
    • Edirne, None Selected, Turkey, 22030
      • Recruiting
      • Trakya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; The group that will not be treated with half swaddling	Behavioral: The Half Swaddling Application; Half swaddling application in term babies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Swaddling: Is it Safe for Your Baby?

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Infant; postpartum depression; half swaddling; maternal sleep quality
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Prospective controlled study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For data privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No