Clinical trial NCT06195410: The Effect of Mother and Father Kangaroo Care on Newborn and Parent Outcomes in Premature Infants
Official title: The Effect of Mother and Father Kangaroo Care on Newborn and Parent Outcomes in Premature Infants: A Randomized Cross Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kangaroo Care
Keywords: Mother Kangaroo Care
Father Kangaroo Care
Cross Over Study
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 38
Sex: ALL
Minimum age (years): 26
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Physiological parameters of the premature infant:respiration rate
timeFrame: Change from baseline, 30min, and 65 min
measure: Physiological parameters of the premature infant:peak heart rate
timeFrame: Change from baseline, 30min, and 65 min
measure: Physiological parameters of the premature infant: oxygen saturation
timeFrame: Change from baseline, 30min, and 65 min
measure: Physiological parameters of the premature infant: body temperature
timeFrame: Change from baseline, 30min, and 65 min
measure: Comfort Behavior scale scores of the premature infant
timeFrame: Change from baseline, 30min, and 65 min
measure: Parent Satisfaction points
timeFrame: baseline and 70 min
measure: Neonatal Intensive Care Unit Parental Stress Scale points
timeFrame: baseline and 70 min
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Selcuk University
name: Busra Yahsi
role: PRINCIPAL_INVESTIGATOR
References: