The Effects of Massage Therapy on Mental and Physical Development of Term Neonates and on Maternal Bonding.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- The rate of pairs that have Edinburgh Postnatal Depression Scale scored > 12
Study 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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 15 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Linh Dao Nguyen Phuong
Principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City