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NCT Number: NCT06750796

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Trakya University

Edirne, None Selected, 22030, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Half Swaddling Application

Behavioral

Half swaddling application in term babies

Primary outcomes

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

    Time frame: Postpartum first 3 months

  2. Pittsburgh Sleep Quality Index

    Time frame: up to 3 months

  3. Edinburgh Postnatal Depression Scale

    Time frame: up to 3 months

  4. Short Infant Sleep Routine Questionnaire

    Time frame: up to 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Hatice Kahyaoglu Sut, 1.

CONTACT

[email protected]

05337662979 ext. +90

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Acronym: Half swaddling

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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