The Effect of Kangaroo Care Method On The Self-Confıdence and Attachment Levels of Fathers of Preterm Babies
1 other identifier
interventional
56
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2024
CompletedFirst Submitted
Initial submission to the registry
October 17, 2024
CompletedFirst Posted
Study publicly available on registry
October 29, 2024
CompletedApril 9, 2025
May 1, 2024
6 months
October 17, 2024
April 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Paternal-Infant Attachment Scale
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 Outcomes (1)
Karitane Parenting Confidence Scale
This assessment scale will be administered to the father one month following the baby's discharge from the hospital.
Study Arms (2)
Study group: Fathers who practicing kangaroo care
EXPERIMENTALThe 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.
Control group: Fathers who not practicing kangaroo care
NO INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Biruni University
Istanbul, 34010, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
October 17, 2024
First Posted
October 29, 2024
Study Start
November 28, 2023
Primary Completion
May 28, 2024
Study Completion
May 28, 2024
Last Updated
April 9, 2025
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
Due to Hospital policy, the individual participant data can not be shared with anyone except researchers.