The Effect of Using Clinical Guidelines on Kangaroo Care on Newborn and Maternal Outcomes

The Effect of Using Clinical Guidelines on Kangaroo Care in Premature Infants on Newborn and Maternal Outcomes: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Premature Infants
• Intervention / Treatment: Other: Kangaroo care based on kangaroo care guide

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Kangaroo care was applied for 65 minutes to premature infants by their mothers based on the kangaroo care guide.	Other: Kangaroo care based on kangaroo care guide; Under the supervision of the researcher, a kangaroo care practice was applied to premature babies by their mothers based on the kangaroo care guide. This practice took 65 minutes. In addition, before the application, the kangaroo application information was explained to the mothers through a brochure.
No Intervention: Control Group; Kangaroo care was routinely administered by the nurse for 65 minutes without using a kangaroo care guide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological parameters of the premature infant:respiration rate	The infant's is respiratory rate per minute.	Change from baseline and 70 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 and 70 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 and 70 min
Physiological parameters of the premature infant: body temperature	Shows body temperature.	Change from baseline and 70 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 and 70 min

Secondary 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
Nurse Parent Support score	Nurse Parent Support scale was used. The scale consists of 21 items and four scales in five-point Likert type (1) "almost never", (2) "sometimes", (3) "sometimes", (4) "often" and (5) "always". consists of sub-scales; "Information and Communication Support" (9 items), "Emotional Support" (3 items), "Respect Support" (4 items), "Quality Care Giving" (5 items) (See Appendix E). The lowest score that can be obtained from the scale is 21, while the highest score is 105. A high score indicates that the support given by the nurse to the parent is high.	baseline and 70 min

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Rabia Ayça Özkan, Konya Beyhekim Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): October 24, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Prematurity; NICU; Kangaroo care; Evidence-based guideline
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: SelcukU-12-2022

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