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

NCT ID: NCT04285437

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2020-12-30

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.

Conditions

Infant Development; Breastfeeding; Postnatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

massage

neonates are massaged by their mother during the first 2 months after birth.

Group Type: EXPERIMENTAL

infant massage

Intervention Type: BEHAVIORAL

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.

control

neonates are not massaged.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

infant massage

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 15 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role: lead

Responsible Party

Linh Dao Nguyen Phuong

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuan Le Minh, Ph.D, MD

Role: STUDY_CHAIR

Research Department, UMP

Locations

University of Medicine and Pharmacy

Ho Chi Minh City, , Vietnam

Site Status: RECRUITING

Countries

Vietnam

Central Contacts

Linh Dao Nguyen Phuong, MD

Role: CONTACT

bs.dnplinh@gmail.com

+84902893839

Duong Pham Diep Thuy, Ph.D, MD

Role: CONTACT

thuyduongpd@ump.edu.vn

+84908143227

Facility Contacts

Linh Dao Nguyen Phuong, MD

Role: primary

bs.dnplinh@gmail.com

+84902893839

Duong Pham Diep Thuy, Ph.D, MD

Role: backup

thuyduongpd@gmail.com

+84908143227

Other Identifiers

414A/ĐHYD-HĐĐĐ

Identifier Type: -

Identifier Source: org_study_id