- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06663579
The Effect of Kangaroo Care Method On The Self-Confıdence and Attachment Levels of Fathers of Preterm Babies
April 6, 2025 updated by: Selmin Kose, Biruni University
This study was conducted as a randomized controlled experimental type to evaluate the confidence and attachment levels of fathers in baby care whose babies were treated in the neonatal intensive care unit.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
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
-
-
-
Istanbul, Turkey, 34010
- Biruni University
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
For Newborns:
- Being a newborn treated in the Istanbul Başakşehir Çam and Sakura Hospital Neonatal Intensive Care Unit
- Gestational age less than 37 weeks
- Postnatal age between 0-28 days
- The baby is considered stable by a neonatologist
- The baby can maintain body temperature during Kangaroo Care
- Safety is ensured if there is an existing umbilical or central catheter
For fathers:
- Agreeing to practice Kangaroo Care
- Having no health condition that would prevent practicing Kangaroo Care
- Being able to maintain sufficient hygiene conditions for Kangaroo Care
- Being literate
- Being able to communicate in Turkish
Exclusion Criteria:
For babies:
- Receiving respiratory support
- Having a chest tube
- Having a congenital anomaly
- Using sedative medication
- Having undergone surgery
For fathers:
- Not wanting to practice Kangaroo Care
- Using substances that cause sedation (drugs, alcohol)
- Having a disease that can be transmitted through skin contact
- Not agreeing to participate in the study
- Not living in the same house as the baby
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group: Fathers who practicing kangaroo care
The premature babies treated in the neonatal intensive care unit where the study was conducted practice kangaroo care with their mothers.
However, in the intervention conducted by the researcher, the babies practiced kangaroo care with both their mothers and fathers.
|
The study group (n=28) It consists of fathers of babies practicing Kangaroo Care with both their mothers and fathers in the neonatal intensive care unit.
|
|
No Intervention: Control group: Fathers who not practicing kangaroo care
The premature babies treated in the neonatal intensive care unit where the study was conducted practice kangaroo care with their mothers.
However, in the intervention conducted by the researcher, the babies practiced kangaroo care with both their mothers and fathers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Paternal-Infant Attachment Scale
Time Frame: This assessment scale will be administered to the father one month following the baby's discharge from the hospital.
|
The scale developed to assess father-infant bonding after birth is a 19-item scale.
It consists of three subdimensions: 'patience and tolerance,' 'enjoyment in interaction,' and 'love and pride'.
Twelve items in the scale are reverse-coded.
Higher scores indicate a higher level of bonding.
While the original version of the scale consists of 19 items, the Turkish version comprises 18 items.
The Cronbach's alpha coefficient of the scale was reported to be 0.81 at 6 months and 0.78 at 12 months.
|
This assessment scale will be administered to the father one month following the baby's discharge from the hospital.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Karitane Parenting Confidence Scale
Time Frame: This assessment scale will be administered to the father one month following the baby's discharge from the hospital.
|
The scale, originally developed by Crncec and colleagues in 2008, was adapted into Turkish by Yılmaz and Oskay in 2021.
It is used to assess the self-confidence of parents regarding their parenting abilities and consists of 14 items designed for parents with infants aged 0 to 12 months.
The scale includes two sub-dimensions: "Infant Care" and "Parenting Role."
Only Item 11 is reverse scored, with the following scoring pattern: 0 = 3; 1 = 2; 2 = 1; 3 = 0.
The total score ranges from 0 to 42, with higher scores indicating a more positive outcome and reflecting higher levels of parental self-confidence.
|
This assessment scale will be administered to the father one month following the baby's discharge from the hospital.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 28, 2023
Primary Completion (Actual)
May 28, 2024
Study Completion (Actual)
May 28, 2024
Study Registration Dates
First Submitted
October 17, 2024
First Submitted That Met QC Criteria
October 27, 2024
First Posted (Actual)
October 29, 2024
Study Record Updates
Last Update Posted (Actual)
April 9, 2025
Last Update Submitted That Met QC Criteria
April 6, 2025
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Biruni Universitesi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to Hospital policy, the individual participant data can not be shared with anyone except researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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