The Effect of Mother and Father Kangaroo Care on Newborn and Parent Outcomes in Premature Infants

NCT ID: NCT06195410

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-18
• Study Completion Date: 2023-08-18

Brief Summary

First aim is to determine the effect of mother and father kangaroo care on the premature baby's Comfort Behavior level and physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature). Second aim is to determine the effect of mother and father kangaroo care on Parental Satisfaction and Neonatal Intensive Care Parental Stress level.

The study was a a randomized crossover study with pretest-posttest design. It was carried out in the neonatal intensive care unit of Selçuk University Faculty of Medicine Hospital in Konya province. Study data were collected from 19 mother and 19 father and their premature newborns between February 2023 and August 2023.

Detailed Description

In the study, the mother applied kangaroo care to her premature baby for 65 minutes, and after a 24-72 hour washout period, the father applied kangaroo care for 65 minutes. The order of mother and father application was determined randomly.

Data were collected using Physiological Parameters Form, Neonatal Comfort Behavior Scale, Parental Satisfaction Scale and Neonatal Intensive Care Unit Parental Stress Scale.

In the study, physiological parameters and Neonatal Comfort Behavior Scale scores of premature infants and Neonatal Intensive Care Unit Parental Stress Scale and Parental Satisfaction Scale scores of parents were evaluated. Pearson Chi-Square Test, Yates Correction and Fisher's Exact Test were used to compare categorical data according to groups. Two Independent Sample t Test was used to compare normally distributed variables and Mann Whitney U Test was used to compare non-normally distributed variables. Statistical significance level was accepted as p˂0.05.

Conditions

Kangaroo Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Comparator: Intervention Group

Group Type: ACTIVE_COMPARATOR

kangaroo care application

Intervention Type: OTHER

In the study, the mother applied kangaroo care to her premature baby for 65 minutes, and after a 24-72 hour washout period, the father applied kangaroo care for 65 minutes.

Comparator

Group Type: SHAM_COMPARATOR

kangaroo care application

Intervention Type: OTHER

In the study, the mother applied kangaroo care to her premature baby for 65 minutes, and after a 24-72 hour washout period, the father applied kangaroo care for 65 minutes.

Interventions

kangaroo care application

In the study, the mother applied kangaroo care to her premature baby for 65 minutes, and after a 24-72 hour washout period, the father applied kangaroo care for 65 minutes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

For premature infants;

• The baby is born before 36+6 weeks of gestation Stability of vital parameters at the time of application, Stable health status (cardiorespiratory stability, no congenital or chromosomal abnormalities, no history of intraventricular hemorrhage, no history of periventricular leukomalacia and NEC, no systemic and metabolic disorders),

For parents;

• Willingness to participate in the research
• Being able to read and write Turkish

Exclusion Criteria

For premature infants;

• Being connected to a mechanical ventilator
• Congenital or chromosomal abnormality
• Being with deprivation syndrome
• Having a history of intraventricular hemorrhage

For parents:

• Not being willing to care for kangaroos
• Having a physical disability to care for kangaroos

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Taş Arslan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Busra Yahsi

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Locations

Selcuk University

Konya, Selcuklu, Turkey (Türkiye)

Selcuk University

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SelcukU-12c-2023

Identifier Type: -

Identifier Source: org_study_id