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

February 24, 2020 updated by: Linh Dao Nguyen Phuong, University of Medicine and Pharmacy at Ho Chi Minh City

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 70000
        • Recruiting
        • University of Medicine and Pharmacy
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: massage
neonates are massaged by their mother during the first 2 months after birth.
Behavioral: 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.
No Intervention: control
neonates are not massaged.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The rate of pairs that have Edinburgh Postnatal Depression Scale scored > 12
Time Frame: at the day baby turns 1 month of age
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
at the day baby turns 1 month of age
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
at the day baby turns 2 month of age
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"
2 months after birth
The rate of pairs that have breastfeeding
Time Frame: at the day baby turns 1 month of age
When home visiting, the investigator collect from "Parenting Dairy"
at the day baby turns 1 month of age
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"
at the day baby turns 2 month of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The mean of Edinburgh Postnatal Depression Scale
Time Frame: at the day baby turns 1 month of age
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
at the day baby turns 1 month of age
The mean of Edinburgh Postnatal Depression Scale
Time Frame: at the day baby turns 2 month of age
When home visiting, the investigator let the mother do 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
Time Frame: 2 months after birth
When home visiting, the investigator collect from "Parenting Dairy"
2 months after birth
Change of the number of spitting up at 2 month - old - infant
Time Frame: 2 months after birth
When home visiting, the investigator collect from "Parenting Dairy"
2 months after birth
Change of weight at 2 month - old - infant
Time Frame: 2 months after birth
When home visiting, the investigator assess the weight of infant
2 months after birth
Change of height at 2 month - old - infant
Time Frame: 2 months after birth
When home visiting, the investigator assess the height of infant
2 months after birth
Change of head circle at 2 month - old - infant
Time Frame: 2 months after birth
When home visiting, the investigator assess the head circle of infant
2 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tuan Le Minh, Ph.D, MD, Research Department, UMP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 414A/ĐHYD-HĐĐĐ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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