Skip to main content
Clinical Trials/NCT04285437
NCT04285437
Unknown
Not Applicable

The Effects of Massage Therapy on Mental and Physical Development of Term Neonates and on Maternal Bonding.

University of Medicine and Pharmacy at Ho Chi Minh City1 site in 1 country120 target enrollmentJanuary 31, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant Development
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Enrollment
120
Locations
1
Primary Endpoint
The rate of pairs that have Edinburgh Postnatal Depression Scale scored > 12
Last Updated
6 years ago

Overview

Brief Summary

This study collects data from 2 groups of mother- term neonate pairs at the Neonatal Department of Children Hospital II, Ho Chi Minh City (in group M: neonates are massaged by their mothers during the first 2 months after birth, in group X: neonates are not massaged), and then, evaluates the effects of Massage Therapy on the mental and physical development of neonates and on maternal bonding (breast feeding, postnatal depression) during the first 2 months after birth.

Detailed Description

Infant Massage has been known for a long time, almost as far back as the first time it was recorded around 1800 BC. This was one of the original forms of medicine before the medical revolution broke out in the 1940s. To date, more than 600 studies have been published on the effects of weight gain on massaged infants, primarily in preterm infants. In addition, the latest research also helps identify other effects such as shortening hospital time, better sleep, reducing pain, crying less, strengthen immunity, reducing bilirubin in neonates with jaundice. On the other hand, the effect of the "parent direct massage for children" is also determined, the reports show an improvement in the parent-child interaction, increase breastfeeding, and reduce breastfeeding. The rate of postpartum depression reduced significantly. Steps to proceed * Step 1: Randomly select 2 groups of mother- term neonate pairs by letting every mother, who matching with eligibility criteria, draw 1 of 120 same color and size lotteries in which include 1 to 120 numbers randomly drawn from a web page https://stattrek.com/statistics/random-number-generator.aspx . There are 2 groups of mother - term neonate pairs (60 pairs each): * Group M: neonates are massaged by their mothers during the first 2 months after birth. Mothers in this group will be given instructions on breastfeeding, and massage therapy (by principal investigator as International Association of Infant Massage Certified Instructor) in 2 days before discharge, and mothers will record "Parenting Dairy" form (The diary includes the number of defecation times, the number of spitting up times, the number of crying times over 15 minutes, the number of massage times, and the sleep time during the day) * Group X: neonates are not massaged. Mothers in this group will be given instructions on breastfeeding only, and they will record "Dairy of taking care baby" form like the other group. * Step 2: At 1 day after discharge, the investigator make a phone call with mothers of group M to track and remind them massage for their babies. * Step 3: At the time of 10 days before the baby turn 1 month - old and 2 month - old, the investigator make a phone call with mothers in both groups to track and remind massage for children (group M), as well as the record "Parenting Dairy" (both groups) * Step 4: At the time the child turn 1 month - old and 2 month - old, the investigator make a home visit to both groups, let mothers perform Edinburgh Postnatal Depression Scale, collect data from "Parenting Dairy", assess the height - weight - head circle of the babies.

Registry
clinicaltrials.gov
Start Date
January 31, 2020
End Date
December 30, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Responsible Party
Principal Investigator
Principal Investigator

Linh Dao Nguyen Phuong

Principal investigator

University of Medicine and Pharmacy at Ho Chi Minh City

Eligibility Criteria

Inclusion Criteria

  • Group of mother and neonate at Neonatal Department of Children Hospital II, Ho Chi Minh City
  • neonate: full term, not low birth weight, 0 - 15 days of age, diagnosed with one of the following conditions and has been treated stably: uncomplicated neonatal infection, uncomplicated pneumonia, non umbilical cord infection, uncomplicated neonatal jaundice
  • mother: live in Ho Chi Minh City

Exclusion Criteria

  • If the mother or neonate has the criteria to eliminate:
  • Mother with mental illness, developmental disorder, prenatal depression, not directly caring for children.
  • Neonate with multiple deformities, asphyxia, severe jaundice with complication, cow's milk allergy, heart/ lung/central nervous system defects.

Outcomes

Primary Outcomes

The rate of pairs that have Edinburgh Postnatal Depression Scale scored > 12

Time Frame: at the day baby turns 2 month of age

When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale

The rate of pairs that have breastfeeding

Time Frame: at the day baby turns 2 month of age

When home visiting, the investigator collect from "Parenting Dairy"

Change of the number of crying times over 15 minutes at 2 month - old - infant

Time Frame: 2 months after birth

When home visiting, the investigator collect from "Parenting Dairy"

Secondary Outcomes

  • Change of the number of spitting up at 2 month - old - infant(2 months after birth)
  • The mean of Edinburgh Postnatal Depression Scale(at the day baby turns 2 month of age)
  • Change of the number of defecation times at 2 month - old - infant(2 months after birth)
  • Change of height at 2 month - old - infant(2 months after birth)
  • Change of weight at 2 month - old - infant(2 months after birth)
  • Change of head circle at 2 month - old - infant(2 months after birth)

Study Sites (1)

Loading locations...

Similar Trials