- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04506541
The Effects Of KC On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory
The Effects Of Birth Kangaroo Care On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
İzmir
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Bornova, İzmir, Turkey, 35100
- Ege University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The inclusion criteria
- 36-38 gestational weeks,
- giving birth at 37 weeks or above,
- single and live fetus,
- having no obstacle for applying kangaroo care,
- accepting kangaroo care implementation,
- no need for intervention of newborn,
- no need of newborn to be referred to the neonatal intensive care unit,
- being able to communicate with the pregnant woman,
- having a cesarean section with spinal or epidural anesthesia.
Exclusion criteria
- being accepted to the delivery room with urgent delivery,
- mothers who did not want to apply kangaroo care,
- mothers who had mental disorders which could harm the baby or self such as postpartum depression,
- the delivery was performed under general anesthesia for pregnant women who had a cesarean delivery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kangaroo Care Group
The pregnant women who were in the kangaroo care group of the study and who were 36-38 weeks of gestation were given 20 minutes of kangaroo care and breastfeeding training by the researcher.
A video about "kangaroo care and breastfeeding" was sent to pregnant women to remind them two weeks after the training.
Kangaroo care application started in the first minute after giving birth in mothers who were in the kangaroo care group and came to the delivery room.
In the first, third, sixth, and ninth months after the discharge of the mothers who started applying kangaroo care, kangaroo care application status, breastfeeding status, baby's growth, and development status were evaluated.
In each follow-up, the baby's height, weight, and head circumference were measured with a standard measuring tool.
|
Kangaroo care application started in the first minute after giving birth in mothers who were in the kangaroo care group and came to the delivery room.
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No Intervention: Control Group
The pregnant women in the control group were not trained other than breastfeeding training given in the hospital.
In the maternity room, routine care practices were performed after delivery of the pregnant women.
As in mothers in the kangaroo care group, in the first, third, sixth, and ninth months after the discharge of mothers, kangaroo care application situations, breastfeeding conditions, growth, and development of the baby were evaluated.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
breastfeeding conditions
Time Frame: from birth to the ninth month
|
Baby's time to start sucking: how many minutes in the first half hour it starts to suck Absorption time: How many minutes it absorbs in the first half hour o Breastfeeding status only: Breastfeeding time of the mother's baby only until the end of the research by using Kangaroo Care and Breastmilk Intake Status Inspection Form. The form was developed by the researcher to monitor and control how long the mother implemented the kangaroo care, the time baby started breastfeeding, the duration of breastfeeding, and the changes in the baby's body weight |
from birth to the ninth month
|
baby's weight
Time Frame: from birth to the ninth month
|
the weight of the baby was evaluated in grams and was measured with a standard measuring tool.
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from birth to the ninth month
|
baby's height
Time Frame: from birth to the ninth month
|
the height of the baby was evaluated in centimeter and was measured with a standard measuring tool.
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from birth to the ninth month
|
baby's head circumferecne
Time Frame: from birth to the ninth month
|
the head circumference of the baby was evaluated in centimeter and was measured with a standard measuring tool.
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from birth to the ninth month
|
baby's development
Time Frame: from birth to the ninth month
|
Baby's first, third, sixth and ninth month developmental status by using Guide to Monitoring and Supporting Development.
There is no scoring in the development monitoring and supporting guide.
In the study, the developmental status of the babies was categorized as "behind by month," "normal by month," and "ahead by month.
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from birth to the ninth month
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maternal attachment
Time Frame: from birth to the ninth month
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Attactment level between mother and baby at postpartum first, third, sixth and ninth months by using Maternal Attachment Scale.
The scale consists of 26 items in a four-point Likert type.
The minimum score that can be obtained from the scale is 26, the maximum score is 104, and the height of the score indicates that the bond between the mother and the baby is high The Cronbach's alpha value of the scale was determined as 0.87 in the study.
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from birth to the ninth month
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rabia GENÇ, Ege University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Kangaroo care at birth
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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