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MothersNCT06348316

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

A study testing Half swaddle and Kangaroo care in people with Mothers and Postpartum Depression, run by Trakya University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Mothers, Postpartum Depression
What is being tested?
Half swaddle and Kangaroo care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Sep 2023to 30 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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,
Show all 20Show fewer
  • Working night shifts,
  • Without stable vital signs,
  • Those who have received infertility treatment,
  • Having a chronic disease (such as hypertension, diabetes mellitus),
  • Experiencing serious depression, anxiety and stress,
  • Having any organic or non-organic disease that may cause cognitive impairment (such as Delirium, Dementia, Mental Retardation, etc.),
  • Serious maternal complications,
  • Mothers who do not volunteer to participate in the study will not be included in the study.
  • For baby;
  • Birth weight of 2500 g or less,
  • Without stable vital signs,
  • Having an APGAR score below 7,
  • Having serious neonatal complications,
  • Babies with congenital malformations will not be included in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Trakya University

    Edirne, 22030

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies: Randomized Controlled Study

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

Read the detailed description

The study will include n=136 mothers who gave birth at term at Trakya University Health Research and Application Center Birth Service. Between 10.09.2023 and 10.07.2024, n=136 (34=control, 34=semi-swaddled, 34=kangaroo care, 34=semi-swaddled and kangaroo care) women who volunteered to participate in the study will be conducted randomly in four groups: case and control.

Before starting the research, four groups will be randomly formed among the mothers. As a randomization method, mothers who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into four groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumber-generator.aspx).

Research data: It was collected using the Survey Form, Edinburgh Postpartum Depression Scale (EPDS) and Pittsburgh Sleep Quality Index (PSQI).

Survey form; It which was prepared by the researchers by reviewing the literature consists of 5 main sections and a total of 82 questions, including the personal characteristics of the mother who gave birth preterm, the characteristics of the birth and the baby, the characteristics of sleep, the characteristics of the baby's sleep pattern, and the characteristics of the baby's growth and development.

Edinburgh Postnatal Depression Scale (EPDS): The scale was developed by Cox and Holden (1987). Adapted to Turkish by Engindeniz, Küey, and Kültür (1996). It is used to determine the risk for depression in the postnatal period and to measure the level and change of violence. It is a self-assessment scale. It is applied to postpartum women. It contains a total of 10 questions and measures depression. It provides a four-point Likert type measurement. The- Page 2 of 8 directive is at the beginning of the scale and subjects are asked to mark the substance most relevant to their situation when filling in the subjects. The total score of the scale is obtained by adding these item scores. As a result of the cut-off point scale study conducted in Turkey and it has ben calculated as 12/13.

Pittsburgh Sleep Quality Index (PSQI): PSQI is a self-reported screening and assessment questionnaire that details information on the type and severity of sleep quality and disorders within the last month. It was developed by Buysse et al., and its validity and reliability study in Turkish was performed by Agargün et al. PUKI evaluates sleep quality in the last month. 18 items and 7 components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction) are included in the scoring. Each item is evaluated over 0-3 points and the sum of 7 component points gives the total PUKI score. The total score ranges from 0 to 21, with higher scores indicating worsening sleep quality. A total PUKI score of ≤5 is considered "good sleep", and >5 is considered "bad sleep".

The survey form and scales will be applied to all four groups at the first meeting. In the groups where half swaddle, kangaroo care and both half swaddle and kangaroo care are applied, necessary information about sleep, such as the mother's sleep duration, frequency of waking up, duration of wakefulness and reasons for waking up, will be recorded before the start of the study and for 24 hours. During the 6 months of the study period, mothers will be called every month by phone and their questions about the application methods and the application will be answered. All scales will be repeated at the beginning, 1st, 3rd and 6th months, and the mother's sleep monitoring for the last 24 hours will be requested again. Practical training on semi-swaddle and kangaroo care will be provided to mothers at the first meeting through prepared presentations.

Data collection The mean scores of PSQI and EPDS at the beginning,1st, 2nd, 3rd, and 6th months of the half swaddling and kangaroo care group Intervention.

Half swaddle: HS applied to a newborn baby makes the baby feel completely safe, as if in the womb. After laying the soft fabric or baby blanket, it was placed in the supine position. Half swaddling was done so as not to restrict the baby's arm and leg movements. HS was performed 15 minutes before each sleep during the day until the 3rd month.

Kangaroo care: The application was applied at twice a day and for 60 min, every day for 6 months in a row. While the mothers were taken to the NICU and practiced at home prior to kangaroo care, hand hygiene and breast care were provided within the scope of infection prevention rules. During KC, the mother placed her baby between two breasts, and the baby's breast was placed on the mother's breast in an upright position. During the application of KC, a quiet, calm and suitable environment was created so that comfort of the baby and mother would not be disturbed. The mother and baby are covered with a blanket. The ambient temperature was 26 centigrade degrees during the kangaroo care. In the continuation of the KB application, the mother was asked to breastfeed her baby. In order to prevent the risk of aspiration of the baby after breastfeeding, the baby was placed in the left lateral position so that the mother and the baby could lie down together. The application steps of the mother's KC were observed by the researcher and the deficiencies, if any, were corrected by discussing with the mother during / after the application.

Control group: The mothers in the control group were given routine care.

Being tested
Half swaddle, Kangaroo care
Keywords
Term baby, Kangaroo care, Half swaddle, Sleep quality
Medical subject headings
Depression, Postpartum, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Half swaddleOther

    Half swaddle: HS applied to a newborn baby makes the baby feel completely safe, as if in the womb. After laying the soft fabric or baby blanket, it was placed in the supine position. Half swaddling was done so as not to restrict the baby's arm and leg movements. HS was performed 15 minutes before each sleep during the day until the 3rd month.

  • Kangaroo careOther

    The application was applied twice a day and for 60 minutes every day for 6 months in a row. During KC, the mother placed her baby between two breasts, and the baby's breast was placed on the mother's breast in an upright position. During the application of KC, a quiet, calm, and the suitable environment was created so that comfort of the baby and mother would not be disturbed. The mother and baby are covered with a blanket. The ambient temperature was 26 centigrade degrees during the kangaroo care. In the continuation of the KB application, the mother was asked to breastfeed her baby. In order to prevent the risk of aspiration of the baby after breastfeeding, the baby was placed in the left lateral position so that the mother and the baby could lie down together. The researcher observed the application steps of the mother's KC, and the deficiencies, if any, were corrected by discussing with the mother during/after the application.

Study groups in NCT06348316
Study groupRoleWhat they receive
ControlNo interventionNot described
Half swaddleExperimentalNot described
Receives: Other: Half swaddle
Kangaroo careExperimentalNot described
Receives: Other: Kangaroo care
Half swaddle+Kangaroo careExperimentalNot described
Receives: Other: Half swaddle; Other: Kangaroo care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    PSQI is a self-reported screening and assessment questionnaire that details information on the type and severity of sleep quality and disorders within the last month. It was developed by Buysse et al., and its validity and reliability study in Turkish was performed by Agargün et al. PUKI evaluates sleep quality in the last month. 18 items and 7 components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction) are included in the scoring. Each item is evaluated over 0-3 points and the sum of 7 component points gives the total PUKI score. The total score ranges from 0 to 21, with higher scores indicating worsening sleep quality. A total PUKI score of ≤5 is considered "good sleep", and >5 is considered "bad sleep".

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

  2. Postpartum depression evaluated using the Edinburgh Postnatal Depression Scale (EPDS)

    The scale was developed by Cox and Holden (1987). Adapted to Turkish by Engindeniz, Küey, and Kültür (1996). It is used to determine the risk for depression in the postnatal period and to measure the level and change of violence. It is a self-assessment scale. It is applied to postpartum women. It contains a total of 10 questions and measures depression. It provides a four-point Likert type measurement. The directive is at the beginning of the scale and subjects are asked to mark the substance most relevant to their situation when filling in the subjects. The total score of the scale is obtained by adding these item scores. As a result of the cut-off point scale study conducted in Turkey and it has ben calculated as 12/13.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2024
  2. Study start30 Sep 2023
  3. Primary completion2 Apr 2024
  4. Study completion30 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06348316
Sponsor's protocol ID
TÜTF-GOBAEK 2023/45
Status last verified
Jan 2025
First submitted
30 Mar 2024
Last updated
30 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kucukkaya B, Cihangir Ozturk T, Erginler G, Temiz M, Ercel O. The Effect of Early-Initiated Half-Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Infants: A Randomized Controlled Trial. Nurs Health Sci. 2025 Mar;27(1):e70066. doi: 10.1111/nhs.70066.

    PubMed 39988313

Questions about this trial

What is this clinical trial studying?

A study testing Half swaddle and Kangaroo care in people with Mothers and Postpartum Depression, run by Trakya University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mother sleep quality evaluated using the Pittsburgh Sleep Quality Index (PSQI) (time frame: change from before implamentation patent and after 1st, 2nd, 3rd, and 6th months of practice.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06348316, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.

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