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

Not Applicable

Recruiting

• Conditions: Infant, Newborn; Maternal Outcome

• Registration Number: NCT06750796
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2023-05-18
• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-12-26
• Last Update Submitted: 2024-12-26
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-06-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, None Selected, Turkey