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Completed

NCT Number: NCT04926402

Kangaroo Care Education Programme (KCEP)

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.

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Key information

Conditions

Kangaroo-Mother Care Method

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Centre

Kuala Lumpur, 56000, Malaysia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kangaroo Care Education Program

Other

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Acronym: KCEP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2021
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.