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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature Infants

Intervention / Treatment
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* Other: Kangaroo care based on kangaroo care guide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 26 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel group (experimental-control)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* 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.<br>|
| No Intervention: Control Group<br>Kangaroo care was routinely administered by the nurse for 65 minutes without using a kangaroo care guide. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kangaroo care, Evidence-based guideline, Prematurity, NICU