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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05807191
Enrollment
40
Registered
2023-04-11
Start date
2022-07-04
Completion date
2022-12-13
Last updated
2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Infants

Keywords

Kangaroo care, Evidence-based guideline, Prematurity, NICU

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.

Interventions

OTHERKangaroo 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.

Sponsors

Selcuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes 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'.

Intervention model description

parallel group (experimental-control)

Eligibility

Sex/Gender
ALL
Age
26 Weeks to 37 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Physiological parameters of the premature infant:peak heart rateChange from baseline and 70 minThe infant's is heart rate per minute. Philips IntelliVue MP40 device was used to monitor heart rete.
Physiological parameters of the premature infant: body temperatureChange from baseline and 70 minShows body temperature.
Comfort Behavior scale scores of the premature infantChange from baseline and 70 minComfort 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.
Physiological parameters of the premature infant:respiration rateChange from baseline and 70 minThe infant's is respiratory rate per minute.
Physiological parameters of the premature infant: oxygen saturationChange from baseline and 70 minOxygen 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.

Secondary

MeasureTime frameDescription
Nurse Parent Support scorebaseline and 70 minNurse 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.
Parent Satisfaction pointsbaseline and 70 minParental 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026