Skip to main content
Clinical Trials/NCT06750796
NCT06750796
Recruiting
Not Applicable

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

Tanta University1 site in 1 country128 target enrollmentMay 18, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant, Newborn
Sponsor
Tanta University
Enrollment
128
Locations
1
Primary Endpoint
Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd months
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 18, 2023
End Date
December 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hatice Kahyaoglu Sut

Assoc. Prof. Dr.

Tanta University

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,
  • 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.),

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,
  • 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.),

Outcomes

Primary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials