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

Primary Purpose

Premature Infants

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kangaroo care based on kangaroo care guide
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Infants focused on measuring Kangaroo care, Evidence-based guideline, Prematurity, NICU

Eligibility Criteria

26 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Selcuk University
  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Kangaroo care was applied for 65 minutes to premature infants by their mothers based on the kangaroo care guide.

Kangaroo care was routinely administered by the nurse for 65 minutes without using a kangaroo care guide.

Outcomes

Primary Outcome Measures

Physiological parameters of the premature infant:respiration rate
The infant's is respiratory rate per minute.
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.
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.
Physiological parameters of the premature infant: body temperature
Shows body temperature.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 20, 2022
Last Updated
April 10, 2023
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05807191
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
December 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infants
Keywords
Kangaroo care, Evidence-based guideline, Prematurity, NICU

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel group (experimental-control)
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Single blinding (to mothers) was performed in this study. Care provider blinding was performed because the mothers did not know whether kangaroo care was carried out in accordance with a guide. In addition, because the premature babies in the study would not know which group they were in, participant blinding was performed. In order to prevent bias in the analysis phase of the data; Analysis was done by an independent statistician. After the statistical analysis was completed and the report of the research was prepared, it was explained how the intervention and control groups were coded. The intervention group was coded with '1' while the control group was coded with the number '2'.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Kangaroo care was applied for 65 minutes to premature infants by their mothers based on the kangaroo care guide.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Kangaroo care was routinely administered by the nurse for 65 minutes without using a kangaroo care guide.
Intervention Type
Other
Intervention Name(s)
Kangaroo care based on kangaroo care guide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physiological parameters of the premature infant:respiration rate
Description
The infant's is respiratory rate per minute.
Time Frame
Change from baseline and 70 min
Title
Physiological parameters of the premature infant:peak heart rate
Description
The infant's is heart rate per minute. Philips IntelliVue MP40 device was used to monitor heart rete.
Time Frame
Change from baseline and 70 min
Title
Physiological parameters of the premature infant: oxygen saturation
Description
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.
Time Frame
Change from baseline and 70 min
Title
Physiological parameters of the premature infant: body temperature
Description
Shows body temperature.
Time Frame
Change from baseline and 70 min
Title
Comfort Behavior scale scores of the premature infant
Description
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.
Time Frame
Change from baseline and 70 min
Secondary Outcome Measure Information:
Title
Parent Satisfaction points
Description
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.
Time Frame
baseline and 70 min
Title
Nurse Parent Support score
Description
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.
Time Frame
baseline and 70 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Ayça Özkan
Organizational Affiliation
Konya Beyhekim Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42060
Country
Turkey
Facility Name
Selcuk University
City
Konya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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