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

Premature Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05807191
• Other study ID #: SelcukU-12-2022
• Status: Completed
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: December 13, 2022

Study information

• Verified date: April 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 13, 2022
• Est. primary completion date: October 24, 2022
• 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 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

Related Conditions & MeSH terms

• Premature Birth
• Premature Infants

Intervention

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.

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 and 70 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 and 70 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 and 70 min
Primary	Physiological parameters of the premature infant: body temperature	Shows body temperature.	Change from baseline and 70 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 and 70 min
Secondary	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
Secondary	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