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

Kangaroo Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06195410
• Other study ID #: SelcukU-12c-2023
• Status: Completed
• Phase: N/A
• Start date: February 18, 2023
• Est. completion date: August 18, 2023

Study information

• Verified date: January 2024
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 18, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Kangaroo Care
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya	Selcuklu
Turkey	Selcuk University	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological parameters of the premature infant:respiration rate	The infant's is respiratory rate per minute.	Change from baseline, 30min, and 65 min
Primary	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
Primary	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
Primary	Physiological parameters of the premature infant: body temperature	Shows body temperature.	Change from baseline, 30min, and 65 min
Primary	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
Primary	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
Primary	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