The Effects of Massage Therapy on Term Neonates Development and on Maternal Bonding
Primary Purpose
Infant Development, Breastfeeding, Postnatal Depression
Status
Unknown status
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
infant massage
Sponsored by
About this trial
This is an interventional supportive care trial for Infant Development focused on measuring infant massage
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.
Sites / Locations
- University of Medicine and PharmacyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
massage
control
Arm Description
neonates are massaged by their mother during the first 2 months after birth.
neonates are not massaged.
Outcomes
Primary Outcome Measures
The rate of pairs that have Edinburgh Postnatal Depression Scale scored > 12
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
The rate of pairs that have Edinburgh Postnatal Depression Scale scored > 12
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
Change of the number of crying times over 15 minutes at 2 month - old - infant
When home visiting, the investigator collect from "Parenting Dairy"
The rate of pairs that have breastfeeding
When home visiting, the investigator collect from "Parenting Dairy"
The rate of pairs that have breastfeeding
When home visiting, the investigator collect from "Parenting Dairy"
Secondary Outcome Measures
The mean of Edinburgh Postnatal Depression Scale
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
The mean of Edinburgh Postnatal Depression Scale
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
Change of the number of defecation times at 2 month - old - infant
When home visiting, the investigator collect from "Parenting Dairy"
Change of the number of spitting up at 2 month - old - infant
When home visiting, the investigator collect from "Parenting Dairy"
Change of weight at 2 month - old - infant
When home visiting, the investigator assess the weight of infant
Change of height at 2 month - old - infant
When home visiting, the investigator assess the height of infant
Change of head circle at 2 month - old - infant
When home visiting, the investigator assess the head circle of infant
Full Information
NCT ID
NCT04285437
First Posted
February 19, 2020
Last Updated
February 24, 2020
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
1. Study Identification
Unique Protocol Identification Number
NCT04285437
Brief Title
The Effects of Massage Therapy on Term Neonates Development and on Maternal Bonding
Official Title
The Effects of Massage Therapy on Mental and Physical Development of Term Neonates and on Maternal Bonding.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Development, Breastfeeding, Postnatal Depression
Keywords
infant massage
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
massage
Arm Type
Experimental
Arm Description
neonates are massaged by their mother during the first 2 months after birth.
Arm Title
control
Arm Type
No Intervention
Arm Description
neonates are not massaged.
Intervention Type
Behavioral
Intervention Name(s)
infant massage
Intervention Description
Mother will be trained how to massage their babies by International Association of Infant Massage (IAIM) Certified Infant Massage Instructor, and then their babies will be massaged by themselves during the first 2 months after birth.
Primary Outcome Measure Information:
Title
The rate of pairs that have Edinburgh Postnatal Depression Scale scored > 12
Description
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
Time Frame
at the day baby turns 1 month of age
Title
The rate of pairs that have Edinburgh Postnatal Depression Scale scored > 12
Description
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
Time Frame
at the day baby turns 2 month of age
Title
Change of the number of crying times over 15 minutes at 2 month - old - infant
Description
When home visiting, the investigator collect from "Parenting Dairy"
Time Frame
2 months after birth
Title
The rate of pairs that have breastfeeding
Description
When home visiting, the investigator collect from "Parenting Dairy"
Time Frame
at the day baby turns 1 month of age
Title
The rate of pairs that have breastfeeding
Description
When home visiting, the investigator collect from "Parenting Dairy"
Time Frame
at the day baby turns 2 month of age
Secondary Outcome Measure Information:
Title
The mean of Edinburgh Postnatal Depression Scale
Description
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
Time Frame
at the day baby turns 1 month of age
Title
The mean of Edinburgh Postnatal Depression Scale
Description
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
Time Frame
at the day baby turns 2 month of age
Title
Change of the number of defecation times at 2 month - old - infant
Description
When home visiting, the investigator collect from "Parenting Dairy"
Time Frame
2 months after birth
Title
Change of the number of spitting up at 2 month - old - infant
Description
When home visiting, the investigator collect from "Parenting Dairy"
Time Frame
2 months after birth
Title
Change of weight at 2 month - old - infant
Description
When home visiting, the investigator assess the weight of infant
Time Frame
2 months after birth
Title
Change of height at 2 month - old - infant
Description
When home visiting, the investigator assess the height of infant
Time Frame
2 months after birth
Title
Change of head circle at 2 month - old - infant
Description
When home visiting, the investigator assess the head circle of infant
Time Frame
2 months after birth
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
15 Days
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linh Dao Nguyen Phuong, MD
Phone
+84902893839
Email
bs.dnplinh@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Duong Pham Diep Thuy, Ph.D, MD
Phone
+84908143227
Email
thuyduongpd@ump.edu.vn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuan Le Minh, Ph.D, MD
Organizational Affiliation
Research Department, UMP
Official's Role
Study Chair
Facility Information:
Facility Name
University of Medicine and Pharmacy
City
Ho Chi Minh City
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linh Dao Nguyen Phuong, MD
Phone
+84902893839
Email
bs.dnplinh@gmail.com
First Name & Middle Initial & Last Name & Degree
Duong Pham Diep Thuy, Ph.D, MD
Phone
+84908143227
Email
thuyduongpd@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Massage Therapy on Term Neonates Development and on Maternal Bonding
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