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

Not Applicable

Completed

• Conditions: Low Birth Weight; Premature; Mother-Infant Interaction; Gain, Weight; Feeding, Breast; Depression, Post-Partum; Breastfeeding

• Registration Number: NCT04908332
• Lead Sponsor: Universidad Nacional de Colombia

Brief Summary

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

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 Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-06-01
• Study Start: 2021-07-22
• Primary Completion: 2021-12-16
• Study Completion: 2021-12-16
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
weight	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.
Kangaroo position days at home	Through study completion, an average of 20 days	Number days that the infant needs to stay in kangaroo position at home

Secondary Outcome Measures

Name	Time	Method
Alert states	Through study completion, an average of 20 days	The mother will observe and record YES OR NO the baby woke up during the intervention
Types of feeding	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)
Perceived maternal parental self-efficacy	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.
Postnatal 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	. 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

Trial Locations

Locations (1)

Programa canguro ambulatorio; 🇨🇴 Bogotá, Colombia