Kangaroo CareNCT06953817
The Effect of Kangaroo Care Education on Mother-Infant Bonding, Maternal and Neonatal Comfort
A study testing Kangaroo Care Intervention Group in people with Kangaroo Care and Pregnant, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Kangaroo Care, Pregnant, Bonding
- What is being tested?
- Kangaroo Care Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 11 Feb 2026
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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.
- Full-term,
- No need for oxygen support,
- No congenital anomalies,
- No infectious diseases,
- Stable general condition.
Who cannot join
- 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,
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- Non-users of phone and/or WhatsApp application,
- Pregnant women expecting multiple babies will be excluded from the study.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Kangaroo Care, Pregnant, Bonding, Comfort
- Being tested
- Kangaroo Care Intervention Group
- Keywords
- Kangaroo care, Neonatal, Mother-Infant Bonding, Neonatal Comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Care Intervention GroupBehavioural
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 at least 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo care group | Experimental | 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. Receives: Behavioral: Kangaroo Care Intervention Group |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Mother-Infant Bonding in Pregnant Women Who Received Kangaroo Care Education in the Third Trimester
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.
Measured: 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
Evaluation of Maternal Comfort in Pregnant Women Who Received Kangaroo Care Education in the Third Trimester
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.
Measured: 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
Evaluation of Neonatal Comfort in Pregnant Women Who Received Kangaroo Care Education in the Third Trimester
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.
Measured: Newborn comfort behaviors will be evaluated within the first 24 hours after birth and again at 4 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 Apr 2025
- Primary completion30 Dec 2025
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kangaroo CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled and quasi-experimental research
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel AVÇİN, University of Yalova
- Investigators
- EMEL AVÇİN, Doctor, Principal investigator, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953817
- Sponsor's protocol ID
- Emel Avcin Kangaroo Care
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06953817
- Acronym / sponsor ID
- Emel Avcin Kangaroo Care
- Conditions
- Kangaroo Care, Pregnant, Bonding, Comfort
- Keywords
- Kangaroo care, Neonatal, Mother-Infant Bonding, Neonatal Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled and quasi-experimental research
| Arm | Type | Receives |
|---|---|---|
| Kangaroo care group | Experimental | Behavioral: Kangaroo Care Intervention GroupIn 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangaroo Care Intervention GroupThe 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 at least 40 minutes. | Behavioural | Kangaroo care group |
Primary outcome
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
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.
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMEL AVÇİN, Doctor principal investigator
University of Yalova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Care Intervention Group in people with Kangaroo Care and Pregnant, run by University of Yalova 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 18 inclusion and 12 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 31 Jul 2026. 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?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.