Infant DevelopmentNCT04285437
The Effects of Massage Therapy on Term Neonates Development and on Maternal Bonding
A study testing infant massage in people with Infant Development and Breastfeeding, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 15 days
- Conditions the study is for
- Infant Development, Breastfeeding, Postnatal Depression
- What is being tested?
- infant massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteVietnam
- Study dates
- 31 Jan 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 15 days
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy
Ho Chi Minh City, 70000
Linh Dao Nguyen Phuong, MD, +84902893839, bs.dnplinh@gmail.com
Duong Pham Diep Thuy, Ph.D, MD, +84908143227, thuyduongpd@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- infant massage
- Keywords
- infant massage
- Medical subject headings
- Breast Feeding, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infant massageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| massage | Experimental | neonates are massaged by their mother during the first 2 months after birth. Receives: Behavioral: infant massage |
| control | No intervention | neonates are not massaged. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the day baby turns 1 month of age
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
Measured: at the day baby turns 2 month of age
Change of the number of crying times over 15 minutes at 2 month - old - infant
When home visiting, the investigator collect from "Parenting Dairy"
Measured: 2 months after birth
The rate of pairs that have breastfeeding
When home visiting, the investigator collect from "Parenting Dairy"
Measured: at the day baby turns 1 month of age
The rate of pairs that have breastfeeding
When home visiting, the investigator collect from "Parenting Dairy"
Measured: at the day baby turns 2 month of age
Secondary outcomes (7)
The mean of Edinburgh Postnatal Depression Scale
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
Measured: at the day baby turns 1 month of age
The mean of Edinburgh Postnatal Depression Scale
When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale
Measured: at the day baby turns 2 month of age
Change of the number of defecation times at 2 month - old - infant
When home visiting, the investigator collect from "Parenting Dairy"
Measured: 2 months after birth
Change of the number of spitting up at 2 month - old - infant
When home visiting, the investigator collect from "Parenting Dairy"
Measured: 2 months after birth
Change of weight at 2 month - old - infant
When home visiting, the investigator assess the weight of infant
Measured: 2 months after birth
Change of height at 2 month - old - infant
When home visiting, the investigator assess the height of infant
Measured: 2 months after birth
Change of head circle at 2 month - old - infant
When home visiting, the investigator assess the head circle of infant
Measured: 2 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start31 Jan 2020
- Primary completion1 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linh Dao Nguyen Phuong, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Tuan Le Minh, Ph.D, MD, Study chair, Research Department, UMP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285437
- Sponsor's protocol ID
- 414A/ĐHYD-HĐĐĐ
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Massage Therapy on Mental and Physical Development of Term Neonates and on Maternal Bonding.
- ClinicalTrials.gov ID
- NCT04285437
- Acronym / sponsor ID
- 414A/ĐHYD-HĐĐĐ
- Conditions
- Infant Development, Breastfeeding, Postnatal Depression
- Keywords
- infant massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| massage | Experimental | Behavioral: infant massageneonates are massaged by their mother during the first 2 months after birth. |
| control | No intervention | –neonates are not massaged. |
Who may qualify
- Ages
- 1 day to 15 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infant massageMother 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. | Behavioural | massage |
Primary outcome
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
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
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"
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"
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"
7 secondary outcomes
The mean of Edinburgh Postnatal Depression Scale
Time frame: 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
Change of the number of defecation times at 2 month - old - infant
Time frame: 2 months after birth
Change of the number of spitting up at 2 month - old - infant
Time frame: 2 months after birth
Change of weight at 2 month - old - infant
Time frame: 2 months after birth
Change of height at 2 month - old - infant
Time frame: 2 months after birth
Change of head circle at 2 month - old - infant
Time frame: 2 months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuan Le Minh, Ph.D, MD study chair
Research Department, UMP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infant massage in people with Infant Development and Breastfeeding, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linh Dao Nguyen Phuong, MD (+84902893839, bs.dnplinh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of pairs that have Edinburgh Postnatal Depression Scale scored > 12 (time frame: at the day baby turns 1 month of age). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.