The Effect of Kangaroo Care on Parents' Perceived Parenting Self-Efficacy, Infant Attachment and Newborn Vital Signs

March 19, 2024 updated by: Saglik Bilimleri Universitesi

Determination of the Effect of Kangaroo Care Applied to Premature Newborns by Their Parents on the Newborn's Vital Signs, Parents' Perceived Parenting Self-Efficacy Level and Infant Attachment

This study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The research is a randomized controlled trial and an experimental research design will be used. The research will be carried out with two groups as experimental (newborns given kangaroo care by both mother and father) and control (newborns given kangaroo care only by the mother) groups.

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06170
        • Recruiting
        • Ankara Etlik City Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Meryem Büşra Borazan
        • Principal Investigator:
          • Gönül Kurt, Assoc.prof.

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:

  • Parents who volunteered to participate in the research
  • Parents who are Turkish citizens and speak Turkish
  • Preterm baby born between 28-37 weeks staying in the neonatal intensive care unit
  • The mother and father do not have any obstacles in taking care of the kangaroo.
  • Mothers and fathers who can come to the hospital regularly on the specified days will be included in the study.

Exclusion Criteria:

  • Not volunteering to participate in the research
  • Parent's inability to speak Turkish
  • Presence of a life-threatening major malformation or serious perinatal complication in the premature baby
  • Babies with umbilical catheters and central venous catheters will not be included in the study.

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Newborns in this group will be given kangaroo care by both their mother and father.
Other: Kangaroo care practice by both mother and father
In this group, kangaroo care will be done by both mother and father. Mothers used the Mother-Infant Attachment Scale and the Perceived Maternal Parenting Self-Efficacy Scale as pretests; Fathers will also complete the Postpartum Father-Infant Attachment Survey and the Perceived Father Parenting Self-Efficacy Form. Mothers and fathers in the application group will be provided with kangaroo care for 45 minutes, 2 days a week for 5 weeks. The baby's vital signs will be monitored 30 minutes before each kangaroo care, at the 15th minute of each kangaroo care, and 30 minutes after the kangaroo care, and will be recorded on the Kangaroo Care Monitoring Form. After kangaroo care was completed at the end of 5 weeks, mothers used the Mother-Baby Attachment Scale and the Perceived Mother Parenting Self-Efficacy Scale as posttests; Postnatal Father-Infant Attachment Questionnaire and Perceived Father Parenting Self-Efficacy Form will be filled out by fathers.
Placebo Comparator: Control group
Newborns in this group will be given kangaroo care by only the mother.
Other: Kangaroo care practice only mother
In the control group, only the mother will care for the kangaroo. The application will be similar to the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mother-To-Infant Bonding Scale
Time Frame: It is designed to be applied from the first day after birth. It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
It will be applied to evaluate the mother's attachment level to her baby. The lowest score that can be obtained from the scale is 0 and the highest score is 24. The higher the score from the scale, the more it indicates a mother-infant attachment problem.
It is designed to be applied from the first day after birth. It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
Perceived Mother Parenting Self-Efficacy Scale
Time Frame: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
It will be applied to measure mothers' perceived parenting self-efficacy. The scale consists of 3 sub-dimensions. These; care procedures, the belief in developing positive baby behaviors, the belief in recognizing the baby's behavior, and mother-baby interaction. The lowest score that can be obtained from the scale is 18 and the highest score is 72.As the score obtained increases, the degree of self-efficacy in mothers increases.
It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
Postnatal Paternal-Infant Attachment Questionnaire
Time Frame: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
It will be applied to measure fathers' attachment levels to their babies. The lowest score that can be obtained from the scale is 18 and the highest score is 90.A high score from the scale indicates high bonding.
It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
Perceived Father Parenting Self-Efficacy Form
Time Frame: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
It is aimed to determine the change in fathers' perceived parenting self-efficacy levels. The lowest score that can be obtained from the form is 0 and the highest score is 10. As the score increases, the degree of self effiacy in father increases.
It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
Physiological parameters of the premature infant: peak heart rate (BPM)
Time Frame: Change from baseline at 5 weeks.
It shows heart rate per minute of the infant. The normal peak heart rate should be between 100-160 BPM.
Change from baseline at 5 weeks.
Physiological parameters of the premature infant: oxygen saturation (%)
Time Frame: Change from baseline at 5 weeks.
Oxygen saturation measures the percentage of oxyhemoglobin in the blood. The normal oxygen saturation should be between % 88 - % 100.
Change from baseline at 5 weeks.
Physiological parameters of the premature infant: body temperature (°C)
Time Frame: Change from baseline at 5 weeks.
It shows body temperature of the infant. The normal body temperature of premature babies should be between 36,5 °C and 37,4 °C.
Change from baseline at 5 weeks.
Physiological parameters of the premature infant:Respiration rate (RPM)
Time Frame: Change from baseline at 5 weeks.
It shows respiratory rate per minute of the infants. The normal respiratory rate of premature babies should be in the range of 40-60 RPM.
Change from baseline at 5 weeks.

Collaborators and Investigators

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

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: Gönül Kurt, Assoc.Prof, Gülhane Sağlık Bilimleri 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)

February 1, 2024

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-EK1-2023-508

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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