Effect of Kangaroo Baby Massage on Mother-infant Interaction at Home (KBM)

March 3, 2022 updated by: Nubia Castiblanco Lopez, Universidad Nacional de Colombia

Effect of a Nursing Intervention on the Mother-baby Kangaroo Interaction at Home in Bogotá

The objective of this randomized clinical trial will determine the effectiveness of nursing intervention (Kangaroo Baby Massage) on the interaction between mothers and premature, low birth weight infants at home The dyad mother- infant of the control group will receive Kangaroo position KP and the dyad mother- infant mothers of the intervention group will receive the Kangaroo Baby Massage KBM

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants and methods: 68 dyads mother-infant will randomize, 34 in intervention KBM group and 34 in control group KP, previous they meet inclusion criteria and accept their participation through informed consent. weight gain and Kangaroo position days at home will be the primaries outcomes. The Alert states, Types of BC feeding, Perceived maternal parental self-efficacy and Postnatal depression. Will be secondary outcomes.

Barnard's mother-child interaction theory supports the study

Study Type

Interventional

Enrollment (Actual)

68

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

  • Colombia
      • Bogotá, Colombia, 111321
        • Programa canguro ambulatorio

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

2 days to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Prematures and low birth weight infants in Kangaroo position with a chronological age less than 3 months
  • The mothers take care the infant at home
  • Baby with a weight equal to or greater than 1800 grams at the time of entry to the study.
  • Baby whose birth was institutional or extra-institutional.
  • Mothers with training in the Kangaroo Mother Program
  • Children controlled in the Ambulatory Kangaroo Mother Program

Exclusion Criteria

  • Children diagnosed with intraventricular hemorrhages grade III and IV or congenital malformations
  • Children who have more than one ambulatory kangaroo control
  • Children who have been at home for more than 3 days without starting the ambulatory kangaroo control
  • Babies with infections and other pathologies that require hospitalization during the study
  • Presence of infectious diseases and other pathologies in the mother that require hospitalization
  • Mother confirmed with positive test for covid 19 at the moment of the randomization
  • Mothers with cognitive problems or mental disorders.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kangaroo baby Massage
The mother will apply the massage. The baby kangaroo will be exposed to the KBM for 10 minutes once a day during the time that the infant need to stay in kangaroo position at home. If the baby wakes up and wants to eat the KBM will be interrupted immediately and the baby will be fed, The temperature will be measured before and after the intervention. The massage will begin 60 minutes after the feed.
Behavioral: Kangaroo Baby Massage
The Kangaroo Baby Massage is an intervention that arose from nursing practice in 1996. It is a therapy that does not require an incubator, fuses massage, kangaroo position and music. KBM is available on video
Other Names:
  • Masaje al Bebé Canguro
  • Nursing intervention KBM
Active Comparator: Kangaroo position
The infant must be in Kangaroo position with the mother semi sitting on bed with elevation of at least 30 degrees during 10 minutes every day until the infant doesn´t need to stay in kangaroo position at home.The temperature will be measured 60 minutes after the feed and 10 minutes after KP. If the baby wakes up and wants to eat the KP will be interrupted immediately and the baby will be fed, then the KP will be completed of time ( 10 minutes) to measure the temperature.
Behavioral: Kangaroo Baby Massage
The Kangaroo Baby Massage is an intervention that arose from nursing practice in 1996. It is a therapy that does not require an incubator, fuses massage, kangaroo position and music. KBM is available on video
Other Names:
  • Masaje al Bebé Canguro
  • Nursing intervention KBM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: Through study completion, an average of 20 days
Weight gain after randomization up to infant doesn´t need to stay in kangaroo position at home.
Through study completion, an average of 20 days
Kangaroo position days at home
Time Frame: Through study completion, an average of 20 days
Number days that the infant needs to stay in kangaroo position at home
Through study completion, an average of 20 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alert states
Time Frame: Through study completion, an average of 20 days
The mother will observe and record YES OR NO the baby woke up during the intervention
Through study completion, an average of 20 days
Types of feeding
Time Frame: Through study completion, an average of 20 days
The mother will report whether or not the baby fed during the intervention and will identify the type of feeding (exclusive breast milk, formula or mixed)
Through study completion, an average of 20 days
Perceived maternal parental self-efficacy
Time Frame: Given by a self-report provided by the mother of the perceived maternal parental self-efficacy questionnaire on day 1 before randomization and day 7 and 14 after randomization
The questionnaire contains 20 items with a Likert scale (1. Totally disagree, 2. disagree, 3. agree and 4. totally agree) the minimum value is 20 and the maximum is 80 and the higher scores means a better outcome.
Given by a self-report provided by the mother of the perceived maternal parental self-efficacy questionnaire on day 1 before randomization and day 7 and 14 after randomization
Postnatal depression
Time Frame: Given by a self-report provided by the mother of the Edinburgh Postnatal Depression Scale on day 1 before randomization and day 7 and 14 after randomization
. This scale contains 10 points of 0, 1, 2 and 3 are given according to the increase in the severity of the symptom. The points for questions 3, 5, 6, 7, 8, 9, 10 are scored in reverse order (3, 2, 1, 0). All points are added together to give the total score. A score of 10+ means worse outcome and shows the probability of depression
Given by a self-report provided by the mother of the Edinburgh Postnatal Depression Scale on day 1 before randomization and day 7 and 14 after randomization

Collaborators and Investigators

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

Sponsor

Universidad Nacional de Colombia

Investigators

  • Study Director: Lucy Vesga Gualdron, Professor, Universidad Nacional de Colombia
  • Study Director: Fred Manrique Abril, Professor, Universidad Nacional de Colombia
  • Principal Investigator: Nubia Castiblanco Lopez, PhD student, Universidad Nacional de Colombia

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.

General Publications

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)

July 22, 2021

Primary Completion (Actual)

December 16, 2021

Study Completion (Actual)

December 16, 2021

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNColombia KBM

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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