Clinical trial NCT05807191: The Effect of Using Clinical Guidelines on Kangaroo Care on Newborn and Maternal Outcomes
Official title: The Effect of Using Clinical Guidelines on Kangaroo Care in Premature Infants on Newborn and Maternal Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infants
Keywords: Kangaroo care
Evidence-based guideline
Prematurity
NICU
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 26
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel group (experimental-control)
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effect of the use of clinical guidelines in kangaroo care (KB) practice on neonatal and maternal outcomes in premature infants.

The study was a single-blind, parallel group (experimental-control), randomized controlled experimental design 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 40 premature newborns between September 2022 and November 2022. Premature infants in the intervention (n = 20) and control groups (n = 20) were determined by randomization method.

Detailed description: Kangaroo care was applied to the intervention group with the Kangaroo Care Guide created by reviewing the current literature, and kangaroo care was applied to the control group with the standard kangaroo care method of the clinic. Data were collected using the Descriptive Information Form, Physiological Parameters Form, Neonatal Comfort Behavior Scale, Nurse-Parent Support Scale, Parental Satisfaction Scale and Kangaroo Care Guide/Checklist for Infants Without Respiratory Support.

Premature infants were followed up with skin-to-skin contact with their mothers in kangaroo care for 65 minutes. In the study, physiological parameters and Neonatal Comfort Behavior Scale scores of premature infants and Nurse-Parent Support Scale and Parental Satisfaction Scale scores of mothers 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 mothers;

* 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 mothers; 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 and 70 min
measure: Physiological parameters of the premature infant:peak heart rate
timeFrame: Change from baseline and 70 min
measure: Physiological parameters of the premature infant: oxygen saturation
timeFrame: Change from baseline and 70 min
measure: Physiological parameters of the premature infant: body temperature
timeFrame: Change from baseline and 70 min
measure: Comfort Behavior scale scores of the premature infant
timeFrame: Change from baseline and 70 min
Secondary outcomes:
measure: Parent Satisfaction points
timeFrame: baseline and 70 min
measure: Nurse Parent Support score
timeFrame: baseline and 70 min
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Konya Beyhekim Hospital
name: Rabia Ayça Özkan
role: PRINCIPAL_INVESTIGATOR
References: