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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Fathers who practicing kangaroo care
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biruni University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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