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Evaluation of the effect of baby massage on reducing neonatal jaundice in healthy neonates born in delivery ward of Vali-asr hospital in 1392-1393

Protocol summary

Summary
This Interventional study aims to evaluate the effect of baby massage on reducing Neonatal jaundice , in 50 neonates. Firstly general information including gestational age, APGAR score, birth weight, sex, number of previous deliveries, and type of delivery is recorded in neonates who meet the inclusion criteria. Then massage is taught to the mothers by educated personnel. Massage is started at day one and continued until day 5. Neonates in the therapy group are massaged twice a day by their mothers(each time 15 minutes). Massage is performed with bare, clean, washed hands,starting with two fingers on the cheeks and around the eyes then moving to the chest and the abdomen with semicircular moves, after that is the extremities and at last the back on both sides of the vertebral column. The massage method is taught to the mothers after the labor and a notebook is given to them in order to record times of massage, times of defecation, and it is advised to both groups to refer to the hospital on 4th day postpartum to check a transcutaneous bilirubin( by the Bilitest) on day 4. Times of defecation is also recorded on day 1-4. In case of admission or the need for phototherapy during the trial , that neonate will be excluded from the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201401089568N6
Registration date: 2014-02-16, 1392/11/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-02-16, 1392/11/27
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Sciences-Research Project
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of baby massage on reducing neonatal jaundice in healthy neonates born in delivery ward of Vali-asr hospital in 1392-1393
Public title
Effect of baby massage on reducing neonatal jaundice
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: gestational age of 37-41 weeks, birth weight of more than 2500 grams, APGAR score of 8-10( 1st and 5th minute), being healthy on all other aspects Exclusion criteria: neonatal jaundice at a level that requires admission and therapy(including phototherapy), presence of asphyxia in neonate(characterized by a umbilical artery Ph of below 7), ABO/Rh incompatibility, G6PD deficiency, induction of labor , suffering from uterine atony after delivery, caesarian section performed because of absence of labor progression, history of blood exchange due to jaundice in a previous child.
Age
From 1 year old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
TUMS-Research Deputy
Street address
TUMS-Ghods st., Keshavarz blvd
City
Tehran
Postal code
14197
Approval date
2014-01-07, 1392/10/17
Ethics committee reference number
24489

Health conditions studied

1

Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal janudice, unspecified

Primary outcomes

1

Description
Serum bilirubin level
Timepoint
Day 4
Method of measurement
Miligram per desilitre in blood test

Secondary outcomes

1

Description
Defecation time
Timepoint
After intervention
Method of measurement
Asking mother

Intervention groups

1

Description
Therapy(Intervention) group: Baby massage is taught to the mothers by a professional personal. it is emphasized that mothers should wash their hands thoroughly up to the elbows before starting the massage. Massage is started on the first day of birth and is continued until the 5th day. Neonates in the therapy group are massaged twice every day for a period of 15 minutes each time, massage is performed using baby oil and bare clean washed hands.Starting with 2 fingers from the face and around the eyes and cheeks then the chest , then the abdomen with semicircular moves and finally the extremities and the back( both sides of the vertebras).
Category
Prevention

2

Description
control group: standard methods, massage is not performed and routine care is given.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
vali-asr hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Maternal,Fetal & Neonatal Research Center
Full name of responsible person
Dr. mamak shariat
Street address
Imama Khomeini hospitals complex,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Maternal,Fetal & Neonatal Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Maternal,Fetal & Neonatal Research Center
Full name of responsible person
Edit Haghnazarian
Position
Medical student
Other areas of specialty/work
Street address
No.29, 2nd St., Homaei ave., Resalat Blvd.
City
Tehran
Postal code
1633835461
Phone
+98 21 8841 6249
Fax
Email
edith.hagh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Breastfeeding Research Center
Full name of responsible person
Hosein Dalili
Position
Assistant Professor
Other areas of specialty/work
Street address
Vali-Asr Hospital
City
Tehran
Postal code
14197
Phone
+98 21 6659 1316
Fax
Email
hoseindalili@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Maternal,Fetal and Neonatal Research Center
Full name of responsible person
Edith Haghnazarian
Position
Medical Student
Other areas of specialty/work
Street address
No.29, 2nd St. Homaii Ave. Resalat Blvd.
City
Tehran
Postal code
1633835461
Phone
+98 21 8841 6249
Fax
Email
edith.hagh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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