NCT05337215

Brief Summary

Objective: This study was conducted in a randomized controlled manner to determine the effect of kangaroo care (KC) on paternal attachment (PA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 28, 2022

Last Update Submit

March 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Father-Baby Attachment Scale The Turkish version

    Father-Baby Attachment Scale The Turkish version was applied by Güleç and Kavlak (2013) to the fathers of infants aged 6-12 months, and the McDonald coefficient was reported to be between 0.52 and 0.80 (Güleç and Kavlak 2013). The scale consists of 19 items and three sub-dimensions: "patience and tolerance". "pleasure in interaction", and "love and pride". Each item on the scale is scored between 1 and 5 points. The minimum score that can be obtained from the scale is 19 and the maximum is 95. High scores indicate that the attachment level is high.

    12 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

While the IIF was applied to control group at the first meeting in the postpartum ward, FIAS was administered by phone or home visit in the third month after the face-to-face interview.There was any intervention for this group

Behavioral: kangaroo father care

kangaroo father care

EXPERIMENTAL

While the IIF was applied to control group at the first meeting in the postpartum ward, FIAS was administered by phone or home visit in the third month after the face-to-face interview.. the first KC was applied within the first 4-6 hours after birth, and the second KC was applied in the postpartum ward under the supervision of the researcher on the first day after birth. The third KC was performed by the fathers themselves at home on the third postpartum day after discharge. Immediately afterwards, the researcher observed the father and baby from an appropriate distance, and the father and the baby had skin-to-skin contact for mean 15-20 minutes.

Behavioral: kangaroo father care

Interventions

The effect of postpartum kangaroo father care on paternal attachment

Control groupkangaroo father care

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • fathers who are aged 18 and 50,
  • married,
  • voluntarily agree to participate in the study,
  • have healthy babies,
  • live with their babies.

You may not qualify if:

  • a history of chronic psychiatric illness
  • antipsychotic medication use
  • babies with premature / low birth weight / congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Yıldırım

Çorum, Çorum, 19600, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 20, 2022

Study Start

February 14, 2020

Primary Completion

September 15, 2020

Study Completion

February 16, 2021

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations