- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07543029
Kangaroo Care: Breastfeeding Success and Maternal Role
The Effect of Kangaroo Mother Care Applied in the Early Postpartum Period to Primiparous Mothers on Breastfeeding Success and Perception of the Maternal Role
Purpose: This is a randomized controlled trial designed to investigate the effects of Kangaroo Mother Care (KMC) applied in the early postpartum period to primiparous mothers on breastfeeding success and the perception of the maternal role.
Methodology and Sample:
Setting and Period: The study will be conducted at the Bucak State Hospital Delivery Unit between June 2025 and June 2026.
Sample Size: Based on G*Power analysis (alpha=0.05, power=80%, effect size d=0.566), a total of 112 mothers (56 intervention, 56 control) will be included, accounting for a 10% potential attrition rate. Participants will be assigned to groups using the sealed envelope method and randomization via www.random.org.
Intervention:
Experimental Group: Following routine care, the newborn will be placed in a "chest-to-chest" position on the mother's bare chest for Kangaroo Care. Intermittent KMC will be maintained for 24 hours, during which breastfeeding attempts will be supported.
Control Group: Mothers and newborns will receive only the hospital's routine care (standard skin-to-skin contact and breastfeeding support).
Data Collection Tools:
Personal Information Form, Semantic Differential Scale-Myself as a Mother (to measure maternal role perception), LATCH Breastfeeding Assessment Tool (to evaluate breastfeeding success).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Intervention Protocol:
Experimental Group: In addition to routine delivery care, newborns will receive Kangaroo Mother Care (KMC). The newborn, wearing only a diaper and a hat, will be placed in an upright "chest-to-chest" position on the mother's bare chest. The infant's head will be maintained in a neutral physiological position, and the back will be covered with a blanket. This intermittent KMC application will be initiated following the first breastfeeding attempt and maintained throughout the first 24 hours postpartum, including during transport and periods of maternal rest.
Control Group: Participants will receive the standard hospital protocol (routine skin-to-skin contact immediately after birth and standard neonatal care). No additional KMC intervention will be applied by the study team.
Data Collection and Measurement Points:Data collection will be conducted at two specific time points to evaluate the effectiveness of the intervention:Baseline (0 Hour): Immediately following the first breastfeeding attempt (within the first hour postpartum), the LATCH Breastfeeding Assessment Tool will be administered to both groups to establish baseline breastfeeding success.Post-Intervention (24th Hour): At the end of the 24th hour postpartum, the LATCH tool will be re-administered to evaluate the change in breastfeeding success. Additionally, the Semantic Differential Scale-Myself as a Mother will be administered at this time point to compare maternal role perception between the two groups.
Statistical Analysis: The normality of the data will be assessed using the Skewness and Kurtosis coefficients. For Breastfeeding Success: A Two-Way Mixed ANOVA will be used to analyze the interaction between "Group" (Experimental vs. Control) and "Time" (0 vs. 24 hours).For Maternal Role Perception: Since this variable is measured only at the 24th hour, an Independent Samples t-test (or Mann-Whitney U test, depending on normality) will be used for inter-group comparison.All analyses will be performed using SPSS 25.0 with a significance level of p < 0.05.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gamzegül ALTAY, Assistant Professor
- Phone Number: +90 464 2141059
- Email: gamzegul.altay@erdogan.edu.tr
Study Locations
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-
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Rize, Turkey (Türkiye)
- Recruiting
- Bucak State Hospital
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Contact:
- Gamzegül ALTAY, Assistant Professor
- Phone Number: +90 464 2141059
- Email: gamzegul.altay@erdogan.edu.tr
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Contact:
- Çiğdem CAN BAYRAK, Medical Doctor
- Phone Number: +90 248 252 9959
- Email: cigdemcan765@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
For mothers:
- It must be the mother's first birth,
- Birth must have been vaginal,
- The mother must be healthy,
- The mother must voluntarily participate in the study,
- The mother must not have any communication-impairing conditions (language, cognitive problems, etc.),
For babies:
- Birth weight must be between 2500-4000 grams;
- The newborn must be healthy,
- Exclusively breastfed,
- The newborn must be at term gestation (38-42 weeks),
- The newborn's Apgar score at 1 and 5 minutes must be above 7,
- The newborn must not have any health problems that could affect breastfeeding (cleft palate, cleft lip, esophageal atresia, etc.).
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kangaroo
Mothers in this group will receive intermittent Kangaroo Mother Care (chest-to-chest contact) for 24 hours postpartum.
|
Newborns will be placed in an upright chest-to-chest position on the mother's bare chest.
This intermittent skin-to-skin contact will be applied in sessions according to the mother's and newborn's stability and comfort, and will be maintained at regular intervals throughout the first 24 hours postpartum.
|
|
No Intervention: Control
Mothers in this group will receive standard hospital postpartum care protocols, including routine skin-to-skin contact and breastfeeding support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LATCH Breastfeeding Assessment Tool
Time Frame: 8 month
|
Developed by Deborah Jehsen and Sheila Wallace in 1993 to assess breastfeeding, it consists of five parameters, each item scored between 0 and 2 points.
The highest possible score on the scale is 10, and the lowest is 0. The validity and reliability of the LATCH Breastfeeding Assessment Tool in Turkey was determined by Yenal and Okumuş in 2003, and it was found to be valid and reliable for the Turkish population.
The validity and reliability coefficient of the LATCH scale is alpha 0.82.
The scale, consisting of 5 evaluation criteria, is formed by combining the first letters of the English words LATCH.
The criteria are as follows; L: Latch on breast A: Audible swallowing T: Type of nipple C: Comfort breast/nipple.
H: Baby holding position
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8 month
|
|
Semantic Difference Scale - Self-Assessment as a Mother
Time Frame: 8 month
|
Developed by Walker et al. (1986), this scale was designed to measure the evaluation dimensions of the concept of "self-assessment as a mother."
The adaptation of the scale to Turkish society was done by Çalışır (2003).
The scale consists of 11 pairs of opposing adjectives, distributed among 22 items.
Each adjective pair is scored from 1 to 7. Three items (3, 7, 8) are evaluated using a reverse scoring system to prevent biased scoring by participants.
A high total score on the scale indicates a positive self-assessment of motherhood (Walker et al., 1986).
While Walker found the internal consistency coefficient to be between 0.81-0.85,
Çalışır found the Cronbach Alpha internal consistency coefficient to be between 0.73-0.74
(Çalışır, 2003).
|
8 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gamzegül ALTAY, PhD, Recep Tayyip Erdogan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- GA-E-40465587-050.01.04-1502
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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