Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies

NCT06348316 | Completed DMC

• 1 other identifier: TÜTF-GOBAEK 2023/45
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: In this prospective, randomized controlled study, it was aimed to examine the effects of early half-swaddle and kangaroo care practices in term babies on maternal sleep quality and postpartum depression. Design: The prospective, randomized controlled study

Conditions

Mothers; Postpartum Depression

Keywords

Term baby; Kangaroo care; Half swaddle; Sleep quality

Outcome Measures

Primary Outcomes (2)

• Mother sleep quality evaluated using the Pittsburgh Sleep Quality Index (PSQI)

  PSQI is a self-reported screening and assessment questionnaire that details information on the type and severity of sleep quality and disorders within the last month. It was developed by Buysse et al., and its validity and reliability study in Turkish was performed by Agargün et al. PUKI evaluates sleep quality in the last month. 18 items and 7 components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction) are included in the scoring. Each item is evaluated over 0-3 points and the sum of 7 component points gives the total PUKI score. The total score ranges from 0 to 21, with higher scores indicating worsening sleep quality. A total PUKI score of ≤5 is considered "good sleep", and \>5 is considered "bad sleep".

  change from before implamentation patent and after 1st, 2nd, 3rd, and 6th months of practice.

• Postpartum depression evaluated using the Edinburgh Postnatal Depression Scale (EPDS)

  The scale was developed by Cox and Holden (1987). Adapted to Turkish by Engindeniz, Küey, and Kültür (1996). It is used to determine the risk for depression in the postnatal period and to measure the level and change of violence. It is a self-assessment scale. It is applied to postpartum women. It contains a total of 10 questions and measures depression. It provides a four-point Likert type measurement. The directive is at the beginning of the scale and subjects are asked to mark the substance most relevant to their situation when filling in the subjects. The total score of the scale is obtained by adding these item scores. As a result of the cut-off point scale study conducted in Turkey and it has ben calculated as 12/13.

  change from before implamentation patent and after 1st, 2nd, 3rd, and 6th month of practice.

Study Arms (4)

Control

NO INTERVENTION

Half swaddle

EXPERIMENTAL

Other: Half swaddle

Kangaroo care

EXPERIMENTAL

Other: Kangaroo care

Half swaddle+Kangaroo care

EXPERIMENTAL

Other: Half swaddle; Other: Kangaroo care

Interventions

Half swaddle OTHER

Half swaddle: HS applied to a newborn baby makes the baby feel completely safe, as if in the womb. After laying the soft fabric or baby blanket, it was placed in the supine position. Half swaddling was done so as not to restrict the baby's arm and leg movements. HS was performed 15 minutes before each sleep during the day until the 3rd month.

Half swaddle; Half swaddle+Kangaroo care

Kangaroo care OTHER

The application was applied twice a day and for 60 minutes every day for 6 months in a row. During KC, the mother placed her baby between two breasts, and the baby's breast was placed on the mother's breast in an upright position. During the application of KC, a quiet, calm, and the suitable environment was created so that comfort of the baby and mother would not be disturbed. The mother and baby are covered with a blanket. The ambient temperature was 26 centigrade degrees during the kangaroo care. In the continuation of the KB application, the mother was asked to breastfeed her baby. In order to prevent the risk of aspiration of the baby after breastfeeding, the baby was placed in the left lateral position so that the mother and the baby could lie down together. The researcher observed the application steps of the mother's KC, and the deficiencies, if any, were corrected by discussing with the mother during/after the application.

Half swaddle+Kangaroo care; Kangaroo care

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For mother;
• Over the age of 18-45,
• Term birth (single birth over 37 weeks),
• After an uncomplicated pregnancy, birth was completed by normal vaginal delivery or cesarean delivery method,
• Not using cigarettes, alcohol or stimulants,
• BMI\<30,
• Not working night shifts,
• Having stable vital signs,
• Those who have not received infertility treatment,
• Does not have a chronic disease (such as hypertension, diabetes mellitus),
• Not experiencing serious depression, anxiety and stress,
• Does not have any organic or non-organic disease that may cause cognitive impairment (such as Delirium, Dementia, Mental Retardation, etc.),
• No serious maternal complications,
• Mothers who volunteer to participate in the research will be included in the study.
• For baby;

You may not qualify if:

• For mother;
• under 18 years old,
• Preterm birth (under 37 weeks and/or multiple birth),
• After a complicated pregnancy, birth has not been completed by normal vaginal delivery or cesarean delivery method,
• Those who use cigarettes, alcohol and stimulants,
• BMI\>30,
• Working night shifts,
• Without stable vital signs,
• Those who have received infertility treatment,
• Having a chronic disease (such as hypertension, diabetes mellitus),
• Experiencing serious depression, anxiety and stress,
• Having any organic or non-organic disease that may cause cognitive impairment (such as Delirium, Dementia, Mental Retardation, etc.),
• Serious maternal complications,
• Mothers who do not volunteer to participate in the study will not be included in the study.
• For baby;

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

Related Publications (1)

• Kucukkaya B, Cihangir Ozturk T, Erginler G, Temiz M, Ercel O. The Effect of Early-Initiated Half-Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Infants: A Randomized Controlled Trial. Nurs Health Sci. 2025 Mar;27(1):e70066. doi: 10.1111/nhs.70066.

  PMID: 39988313 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Sleep Initiation and Maintenance Disorders

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 4, 2024
• Study Start: September 30, 2023
• Primary Completion: April 2, 2024
• Study Completion: July 30, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

TU (1)