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Recruiting NCT06750796

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

No phase Interventional Infant, Newborn Maternal Outcome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Half Swaddling Application.
Who it may be relevant to
Registry conditions: Infant, Newborn, Maternal Outcome. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral The Half Swaddling Application
    Half swaddling application in term babies

Primary outcome measures

  • Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd months [Time frame: Postpartum first 3 months]
  • Pittsburgh Sleep Quality Index [Time frame: up to 3 months]
  • Edinburgh Postnatal Depression Scale [Time frame: up to 3 months]
  • Short Infant Sleep Routine Questionnaire [Time frame: up to 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Trakya University — Edirne

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. PMID 33251063

Identifiers

NCT: NCT06750796 · Prospective controlled study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗