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

NCT ID: NCT05807191

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2022-12-13

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.

Conditions

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Premature Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel group (experimental-control)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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'.

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

Kangaroo care based on kangaroo care guide

Intervention Type OTHER

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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

26 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Taş Arslan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rabia Ayça Özkan

Role: PRINCIPAL_INVESTIGATOR

Konya Beyhekim Hospital

Locations

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Selcuk University

Konya, Selcuklu, Turkey (Türkiye)

Site Status

Selcuk University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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SelcukU-12-2022

Identifier Type: -

Identifier Source: org_study_id

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