NCT06663579

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
Last Updated

April 9, 2025

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

October 17, 2024

Last Update Submit

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

EXPERIMENTAL

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.

Other: Fathers who practicing kangaroo care

Control group: Fathers who not practicing kangaroo care

NO INTERVENTION

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.

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.

Study group: Fathers who practicing kangaroo care

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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)

Location

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.

Locations