The Effect of Kangaroo Care Education on Mother-Infant Bonding, Maternal and Neonatal Comfort

July 30, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Kangaroo Care Intervention Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
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
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.
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
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.
Newborn comfort behaviors will be evaluated within the first 24 hours after birth and again at 4 weeks postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Yalova

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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