The Effect of Kangaroo Father Care Transport on Preterm Infants

December 9, 2024 updated by: Zeynep Büşra GÜÇLÜ

The Effect of Kangaroo Father Care Transport on Physiological Parameters, Anxiety and Paternal Attachment in Preterm Infants: A Randomized Controlled Study

This study was planned to investigate the effect of paternal kangaroo care and transport on physiologic parameters, anxiety and paternal attachment in preterm infants.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was conducted to determine the effects of paternal kangaroo care and transport of preterm infants on the physiologic parameters of the infant and the anxiety and attachment levels of the fathers.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Turkey
    • Selçuklu
      • Konya, Selçuklu, Turkey, 42000
        • Selcuk 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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:Neonatal related;

  • Born by caesarean section,
  • Born at 34-36+6 weeks gestation,
  • Apgar score of 7 and above at 1 and 5 minutes,
  • Stable and healthy,
  • Infants with a body weight of 1500 g and above were included. It's about the father;
  • Who volunteered to participate in the study,
  • No mental and psychological problems,
  • No communication problems (speech, hearing and severe visual impairment),
  • Fathers who did not carry contact-transmitted diseases (Covid-19, herpes simplex, scabies, etc.) were included.

Exclusion Criteria:- Congenital anomalies,

  • Abdominal defects such as ompholocele, diaphragmatic hernia, gastroschisis,
  • Receiving invasive and noninvasive respiratory support,
  • With chest tube and umbilical catheter,
  • Foreign babies and their fathers were ostracized.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implementation of paternal early kangaroo care transport
Early kangaroo care was administered immediately after delivery. The fathers were seated on a wheelchair for transportation from the gynecology operating room to the NICU. The newborn was then dressed in a diaper and hat. The preterm baby was laid naked on the father's bare chest in an upright position. Preterms were secured with a kangaroo care garment in the frog leg position in the prone position with the head turned to the side. The baby was covered with a blanket to prevent heat loss.
Behavioral: kangaroo care
Transport practice with paternal kangaroo care in preterm infants
No Intervention: Control Group
The babies in the control group were transported to the NICU in the arms of the nurse after birth as in the clinical routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological Parameter Monitoring Form-Heart Rate
Time Frame: 3 minutes before the intervention
Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
3 minutes before the intervention
Physiological Parameter Monitoring Form-SPO2
Time Frame: 3 minutes before the intervention
SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
3 minutes before the intervention
Physiological Parameter Monitoring Form-Body temperature (°C)
Time Frame: 3 minutes before the intervention
Body temperature (°C) in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
3 minutes before the intervention
Father-Infant Information Form-Paternal characteristics, maternal characteristics and infant characteristics
Time Frame: 15 minutes before the intervention
Paternal characteristics (age, number of children, educational status, employment status, income status and kangaroo care experience), maternal characteristics (age, educational status, employment status, health problems during pregnancy) and infant characteristics (date of birth, gestational week, gender, birth weight, birth length, birth head circumference, APGAR score, type of anesthesia at birth) were recorded before the intervention.
15 minutes before the intervention
State Anxiety Scale
Time Frame: 15 minutes before the intervention
State Anxiety Scale was recorded 15 minutes before the intervention.
15 minutes before the intervention
Father-Infant Attachment Scale
Time Frame: 15 minutes before the intervention
Father-Infant Attachment Scale was recorded 15 minutes before the intervention.
15 minutes before the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological Parameter Monitoring Form-Heart Rate
Time Frame: 3 minutes after the end of kangaroo care (T2).
Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care
3 minutes after the end of kangaroo care (T2).
Physiological Parameter Monitoring Form-Heart Rate
Time Frame: 3 minutes after initiation of transport with kangaroo care.(T1)
Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T1) initiation of transport with kangaroo care.
3 minutes after initiation of transport with kangaroo care.(T1)
Physiological Parameter Monitoring Form-SPO2
Time Frame: 3 minutes after initiation of transport with kangaroo care.(T1)
SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T1) initiation of transport with kangaroo care.
3 minutes after initiation of transport with kangaroo care.(T1)
Fizyolojik Parametre İzleme Formu-SPO2
Time Frame: 3 minutes after the end of kangaroo care (T2)
SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care
3 minutes after the end of kangaroo care (T2)
Physiological Parameter Monitoring Form-Body temperature (℃)
Time Frame: 3 minutes after initiation of transport with kangaroo care.(T1)
Body temperature (℃) in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T1) initiation of transport with kangaroo care.
3 minutes after initiation of transport with kangaroo care.(T1)
Physiological Parameter Monitoring Form-Body temparature (℃)
Time Frame: 3 minutes after the end of kangaroo care (T2).
Body temparature (℃) in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care
3 minutes after the end of kangaroo care (T2).
State Anxiety Scale
Time Frame: 15 minutes before the intervention (T2)
State Anxiety Scale 15 minutes after the end of the intervention (T2)
15 minutes before the intervention (T2)
Father-Infant Attachment Scale
Time Frame: 15 minutes after the intervention.
Father-Infant Attachment Scale was recorded 15 minutes after the intervention.
15 minutes after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeynep Büşra GÜÇLÜ

Collaborators

Selcuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 3, 2023

Primary Completion (Actual)

June 16, 2024

Study Completion (Estimated)

December 24, 2024

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Selcuk University Health Care

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be shared after the article is published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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