CompletedNot Applicable

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

Turkey (Türkiye)136 participantsStarted 2023-09-30

Plain-language 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

Who can participate

Age range

18 Years – 49 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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; * Having a birth weight above 2500 g, * Having stable vital signs, * Having an APGAR score above 7, * No serious neonatal complications, * Babies without congenital malformations will be included in the study. Exclusion Criteria: 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 depr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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)

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

Trial details

NCT IDNCT06348316

SponsorTrakya University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-02

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