Kangaroo Care Education Programme (KCEP) (KCEP)

June 11, 2021 updated by: Sharmiza Samsudin, University of Malaya

Effectiveness of Kangaroo Care Education Programme on Mothers, Nurses, and Infants Outcomes in Neonatal Intensive Care Unit

A quasi-experimental and longitudinal study was conducted to evaluate the effectiveness of the kangaroo care education program (KCEP) on Mothers, Nurses, and Infants Outcomes in a Neonatal Intensive Care Unit. Forty-eight mother-infant dyads were enrolled per arm in the control and experimental groups. The control group received standard routine care, while the experimental group received a maternal kangaroo care education program.

Study Overview

Status

Completed

Detailed Description

Introduction:

Kangaroo care (KC) is a simple, low cost and highly effective evidence-based nursing intervention that can benefit from mother-infant bonding attachment. Most mothers of premature infants will experience stress being separated from their premature infants. Bonding with premature infants will develop their brain and also make them feel loved, safe, and secure. Therefore, KC will help in bonding attachment, increase weight gain, decrease hospitalization, and increase breastfeeding rates.

Aim:

This study aims to investigate the effectiveness of two programs; a nursing education program and a mother education program regarding KC techniques on mothers, nurses, and infant outcomes.

Method:

A combination of two designs: Quasi-experimental and longitudinal designs with self-administered questionnaires were carried out to evaluate mothers, nurses, and infant outcomes using the Kangaroo Care Questionnaires Survey (KCQs) and Parental Stressor Scale: Neonatal Intensive Care Unit, Parental and Relationship (PSS: NICU: P&R) at a neonatal intensive care unit (NICU) of a Malaysian teaching hospital in Klang Valley. The kangaroo care education program (KC-EP) included theoretical and practical sessions on the KC benefits and hands-on KC techniques. The study consisted of three phases: Phase I (n=48 mother-infants dyads) in the control group, Phase II (n=47 nurses - KC-EP), and Phase III (n=48 mother-infants dyads-KC-EP) in the experimental group. Data collection for mothers and infants occurred at various time points during the study; pre-intervention (T0) post - 1-month intervention (T1) and post - 3-month intervention (T2). For the nursing outcomes occurred before and after the 7th day of the intervention program. The results were analyzed using the Statistical Package of Social Sciences(SPSS) version 23. Descriptive statistics were used to analyze the demographic data and items of the questionnaire. GLM univariate and repeated measure analysis of variance (RM-ANOVA) followed by Bonferroni test for mean comparison between control and experimental groups at (T0, T1, and T2).

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
        • University Malaya Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premature infant at corrected age between 28 weeks to 36+6 weeks gestation.
  • Both mothers and premature infants were medically and surgically stable.
  • Mothers were willing to perform KC and admitted to the NICU.

Exclusion Criteria:

  • Surgical infant i.e cleft lip, cleft palate, spina bifida, exomphalos, and omphalocele.
  • Infant required medical treatment eg. prolonged phototherapy treatment.
  • Trisomy 21.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
The control group received standard routine care
Experimental: Kangaroo care education program
The experimental group received a maternal kangaroo care education program
It is a special method of caring for a premature infant in which the baby is positioned for at least 1 hour a day in an upright skin-to-skin and chest-to-chest contact with its mother.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline perceptions of KC at 1-month and 3-month among the mothers.
Time Frame: Baseline, 1-month, and 3- month.
The respondents were asked to answer 20 items on perceptions of KC. A 5-point Likert scale was used (strongly disagree-1 to strongly agree-5). A lower mean score reflecting a better perception of KC.
Baseline, 1-month, and 3- month.
Change from baseline knowledge of KC at 1-month and 3-month among the mothers.
Time Frame: Baseline, 1-month, and 3- month.
The respondents were asked to answer 11 items on knowledge of KC. They were given 'true', 'false', and 'not sure' to indicate their knowledge of KC, with higher mean scores indicating a better level of knowledge
Baseline, 1-month, and 3- month.
Change from baseline perceived barrier to KC at 1-month and 3-month among the mothers.
Time Frame: Baseline, 1-month, and 3- month.
The respondents were asked to answer 19 items on perceived barriers to practicing KC. The scale ranged from very influential (5) to not influential at all (1). A lower mean score of perceived barriers means the mothers are very positive.
Baseline, 1-month, and 3- month.
Change from baseline perceived stress at 1-month and 3-month among the mothers.
Time Frame: Baseline, 1-month, and 3- month.
The respondents were asked to answer 19 items on perceived stress level. A 5-point Likert scale ranging from not at all stressful (1) to extremely stressful (5), to reflect the level of stress faced by mothers with their premature infant's admission into the NICU. The lower the mean stress scores reported by the mothers, the lower the stress level.
Baseline, 1-month, and 3- month.
Change from baseline weight gain at 1-month and 3 month among infants.
Time Frame: Baseline, 1-month, and 3- month
The infants' weight were measured and recorded.
Baseline, 1-month, and 3- month
Change in number of days of hospitalization among the infants.
Time Frame: From day of admission at 28 weeks of gestation until 44 weeks of hospitalization.
The infants' days of hospitalization were recorded.
From day of admission at 28 weeks of gestation until 44 weeks of hospitalization.
Change from baseline breast feeding status at 1-month and 3-month among the infants.
Time Frame: Baseline, 1-month and 3-month
The breast feeding status of infants were recorded.
Baseline, 1-month and 3-month
Change from baseline perceptions of KC at 1-month and 3-month among the nurses.
Time Frame: Baseline, 1-month and 3-month
The respondents were asked to answer 20 items on perceptions of KC. A 5-point Likert scale was used (strongly disagree-1 to strongly agree-5). A lower mean score reflecting a better perception of KC.
Baseline, 1-month and 3-month
Change from baseline knowledge of KC at 1-month and 3-month among the nurses.
Time Frame: Baseline, 1-month and 3-month
The respondents were asked to answer 11 items on knowledge of KC. They were given 'true', 'false', and 'not sure' to indicate their knowledge of KC, with higher mean scores indicating a better level of knowledge.
Baseline, 1-month and 3-month
Change from baseline practice of KC at 1-month and 3-month among the nurses.
Time Frame: Baseline, 1-month and 3-month
Respondents were asked to answer 11 items on practice of KC. A 5-point Likert scale. The descriptors were: very uncomfortable (1), somewhat uncomfortable (2), neither comfortable (3), somewhat comfortable (4) and very comfortable (5). A lower mean score indicated a high level of confidence and skills in initiating KC.
Baseline, 1-month and 3-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sharmiza Samsudin, PhD, University Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2018

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

June 11, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Actual)

June 15, 2021

Last Update Submitted That Met QC Criteria

June 11, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201765-5310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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