- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06953817
The Effect of Kangaroo Care Education on Mother-Infant Bonding, Maternal and Neonatal Comfort
February 13, 2026 updated by: Emel AVÇİN, University of Yalova
The Effect of Kangaroo Care Education Given to Pregnant Women in the Third Trimester on Mother-Infant Bonding, Maternal and Neonatal Comfort: A Randomized Controlled Trial
Kangaroo care encompasses early and continuous skin-to-skin contact, frequent and regular breastfeeding, early discharge from the hospital, and other supportive care practices necessary for the infant .
Through kangaroo care, the transition of newborns from intrauterine to extrauterine life is facilitated, and a strong and secure bond between the mother and the newborn is established.
Kangaroo care, which does not require any additional equipment or special preparation, is a safe method that can be easily and frequently implemented due to its numerous benefits.
Since maternal and neonatal health affects not only the family but also public health, maternal and neonatal comfort is considered to be of great importance.
Kangaroo care is believed to contribute positively to the enhancement of this comfort and the strengthening of the mother-infant bond.
Despite the well-documented benefits of kangaroo care in the literature, its implementation in our country has not reached the desired level.
This study is planned to determine the effect of kangaroo care education provided to pregnant women in the third trimester on mother-infant bonding and maternal and neonatal comfort.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Yalova, Turkey (Türkiye), 77200
- Yalova University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Inclusion Criteria for Pregnant Women:
- Aged 18 years or older,
- Primiparous (first pregnancy),
- Between 35-38 weeks of gestation,
- Able to speak Turkish and/or without communication barriers,
- At least a primary school graduate,
- A healthy pregnancy,
- Good health status during and after delivery,
- No contraindications for providing kangaroo care,
- No physical and/or mental health issues,
- No infectious diseases transmitted through contact,
- Willing to participate in the study,
- Use of WhatsApp application,
- Pregnant women expecting a single baby will be included in the study.
Inclusion Criteria for the Infant:
- Full-term,
- No need for oxygen support,
- No congenital anomalies,
- No infectious diseases,
- Stable general condition.
Exclusion Criteria:
- Exclusion Criteria for Pregnant Women:
- Multiparity,
- Foreign nationals, migrants, or those with communication difficulties,
- High-risk pregnancies,
- Physical and/or mental health issues,
- Presence of an infectious disease transmitted through contact,
- Refusal to participate in the study,
- Non-users of phone and/or WhatsApp application,
- Pregnant women expecting multiple babies will be excluded from the study.
Exclusion Criteria during Data Collection:
- Women who no longer wish to continue in the study after volunteering,
- Women who cannot be reached via WhatsApp and/or phone,
- Women whose infants experience death (exitus),
- Women whose infants have conditions preventing the application of kangaroo care will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
In the initial visit, kangaroo care education will be provided to the pregnant women through a guide/presentation prepared by the researchers, accompanied by hands-on training with a baby.
Later, the pregnant women will practice it with a non-real baby.
The kangaroo care video prepared by the researchers will be sent to the pregnant women.
A chart will be provided to track how many times the pregnant women watch the video.
Throughout the study, messages regarding kangaroo care will be sent to the mothers.
After being informed by the mothers/fathers that labor has started, they will be visited at the hospital within the first 24 hours.
The infant information form, mother-infant bonding scale, kangaroo care comfort scale, and neonatal comfort behavior scale will be completed.
Pregnant women will be asked to continue kangaroo care for four weeks after delivery, and at the end of this period, data collection forms will be completed via WhatsApp.
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The mother should wear a comfortable outfit that can be easily opened at the front, and attention should be given to the mother's privacy.
The infant should be covered with a light blanket.
While applying kangaroo care, the baby may be completely naked, or the baby may wear items such as a hat, diaper, and socks.
The kangaroo care position involves placing the baby upright between the mother's breasts.
The newborn's abdomen should be positioned at the level of the mother's epigastric region.
While performing kangaroo care, the mother should ensure that the baby's face is visible and that the baby's head is not in extreme extension or excessive flexion.
During the procedure, care should be taken to ensure that the baby can breathe comfortably while on the mother's chest.
The pregnant women will be instructed to practice kangaroo care intermittently for 30 minutes.
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No Intervention: Control group
No intervention will be applied to the control group.
The pregnant women will be informed about their expected delivery date and will be instructed to notify the researchers when labor begins.
After being informed by the mothers/fathers that labor has started, they will be visited within the first 24 hours at the hospital, and the infant information form, mother-infant bonding scale, kangaroo care comfort scale, and neonatal comfort behavior scale will be completed.
Four weeks later, the data collection forms will be sent via WhatsApp, and the participants will be asked to complete them.
At the end of the study, it will be announced that the study has concluded.
At the conclusion of the study, the mothers in this group will also receive a guide and video about the importance and application of kangaroo care via WhatsApp.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Mother-Infant Bonding in Pregnant Women Who Received Kangaroo Care Education in the Third Trimester
Time Frame: At the time of first participation in the study in the third trimester, within the first 24 hours after delivery, and 4 weeks after delivery
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After being informed by the mother/father that labor has started, they will be visited at the hospital within the first 24 hours.
During this visit, it will be inquired whether the mother has applied kangaroo care, and she will be encouraged to do so.
The infant information form, mother-infant bonding scale will be completed.
As the final follow-up, a video call will be conducted with the mother 4 weeks later, and she will be asked to complete the survey forms sent via WhatsApp.
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At the time of first participation in the study in the third trimester, within the first 24 hours after delivery, and 4 weeks after delivery
|
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Evaluation of Maternal Comfort in Pregnant Women Who Received Kangaroo Care Education in the Third Trimester
Time Frame: At the time of first participation in the study in the third trimester, within the first 24 hours after delivery, and 4 weeks after delivery
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The infant information form, mother kangaroo care comfort scale will be completed.
As the final follow-up, a video call will be conducted with the mother 4 weeks later, and she will be asked to complete the survey forms sent via WhatsApp.
|
At the time of first participation in the study in the third trimester, within the first 24 hours after delivery, and 4 weeks after delivery
|
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Evaluation of Neonatal Comfort in Pregnant Women Who Received Kangaroo Care Education in the Third Trimester
Time Frame: Newborn comfort behaviors will be evaluated within the first 24 hours after birth and again at 4 weeks postpartum.
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The infant information form, neonatal comfort behaviour scale will be completed.
As the final follow-up, a video call will be conducted with the mother 4 weeks later, and she will be asked to complete the survey forms sent via WhatsApp.
|
Newborn comfort behaviors will be evaluated within the first 24 hours after birth and again at 4 weeks postpartum.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: EMEL AVÇİN, Doctor, University of Yalova
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2025
Primary Completion (Actual)
December 30, 2025
Study Completion (Actual)
February 11, 2026
Study Registration Dates
First Submitted
April 15, 2025
First Submitted That Met QC Criteria
April 23, 2025
First Posted (Actual)
May 1, 2025
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 13, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Emel Avcin Kangaroo Care
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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