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

The Effect of Mother and Father Kangaroo Care on Newborn and Parent Outcomes in Premature Infants: A Randomized Cross Over Study

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.

Study Overview

• Status: Completed
• Conditions: Kangaroo Care
• Intervention / Treatment: Other: kangaroo care application

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Selcuk University
  • Selcuklu
    • Konya, Selcuklu, Turkey, 42060
      • Selcuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Comparator	Other: 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.
Active Comparator: Comparator: Intervention Group	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Satisfaction points	Parental Satisfaction scale was used. This scale was developed to assess parents' satisfaction in NICU. EMPATHIC-30 scale, 1= definitely not; 6 = absolutely yes and consists of five sub-dimensions; information (5 items), care and treatment (8 items), organization (5 items), parent involvement (6 items) and the professional attitude of the staff (6 items). One point represents the lowest satisfaction, while 6 points represents the highest satisfaction.	baseline and 70 min
Physiological parameters of the premature infant:respiration rate	The infant's is respiratory rate per minute.	Change from baseline, 30min, and 65 min
Physiological parameters of the premature infant:peak heart rate	The infant's is heart rate per minute. Philips IntelliVue MP40 device was used to monitor heart rete.	Change from baseline, 30min, and 65 min
Physiological parameters of the premature infant: oxygen saturation	Oxygen saturation measures the percentage of oxyhemoglobin (oxygen-bound hemoglobin) in the blood, and it is represented as arterial oxygen saturation (SaO2) and venous oxygen saturation (SvO2). Philips IntelliVue MP40 device was used to monitor %SpO2.	Change from baseline, 30min, and 65 min
Physiological parameters of the premature infant: body temperature	Shows body temperature.	Change from baseline, 30min, and 65 min
Comfort Behavior scale scores of the premature infant	Comfort Behavior scale was used. The Neonatal Comfort Behavior Scale (NEAS) is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. Each item in the scale is scored from 1 to 5. It is evaluated over the total score. The lowest score that can be obtained from the Newborn Comfort Behavior Scale (NEAS) is 6, and the highest score is 30.	Change from baseline, 30min, and 65 min
Neonatal Intensive Care Unit Parental Stress Scale points	Neonatal Intensive Care Unit Parental Stress Scale was used.The scale is a 34-item Likert-type scale with three subscales (Sights and Sounds, Infant Behavior and Appearance, and Parental Role Changes). Responses to the scale rate parents' stress level for each item from 1 (not at all stressful) to 5 (very stressful). As the scale score increases, stress increases.	baseline and 70 min

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Busra Yahsi, Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2023
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cross Over Study; Mother Kangaroo Care; Father Kangaroo Care
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: SelcukU-12c-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No