Determination of the effect of washing the baby and massage on the physiological jaundice in newborns
Design
In this research 90 newborns are born Association were chosen purposefully Then, newborns , were randomly divided into three control and intervention groups.
Settings and conduct
A study was conducted on the effect of infant washing and massage on physiological jaundice in Ardakan Ziaee Hospital. Birth children were randomly divided into three groups. The study was a blind clinical trial and the assistant was blind to the data.
Participants/Inclusion and exclusion criteria
Admission criteria: Apgar score greater than 7 and gestational age 38 to 42 weeks, weight greater than 2500 g, Clear anomalies
Exit criteria: Apgar 7 and under 7, admission to the newborn
Intervention groups
Massage group: Massage was performed twice a day for 5 days
Washing group :Babies were washed immediately after birth
Control group: Infants received routine care
Main outcome variables
Both massage and washing stimulate the secretion of gastrin, prevent breast feeding and reduce the physiologic jaundice.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170911036118N1
Registration date:2018-01-17, 1396/10/27
Registration timing:retrospective
Last update:2018-01-17, 1396/10/27
Update count:0
Registration date
2018-01-17, 1396/10/27
Registrant information
Name
Effat Noroozi
Name of organization / entity
Shahid Sadoughi University of Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35322246041
Email address
e.noroozi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
2017-02-19, 1395/12/01
Actual recruitment end date
2017-05-20, 1396/02/30
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Baby's Washing and Massage in Physiological Jaundice in Infants
Public title
' Effect of Massage and Washing in Physiological Jaundice''
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All babies born with fetal age range 37 to 42 weeks
weight more than 2500 grams
Apgar above 7 after birth
lack of obvious congenital anomaly
Exclusion criteria:
Pathological jaundice,Baby hospitalization, Canceling the plan
Age
From 1 day old to 7 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Actual sample size reached:
71
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method:Simple randomization
Randomization tool: Wax sealed.
Three envelopes were placed inside the envelopes 1, 2 and 3. The investigator randomly selected one of the envelopes and determined by the number inside the group in which the baby was placed.
Blinding (investigator's opinion)
Not blinded
Blinding description
It was a blind one study.The investigator's assistant checked the bilirubin on the prescribed days, and was unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Yazd University of Medical Science; Alam Square, Safayeh, sYazd
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2016-12-25, 1395/10/05
Ethics committee reference number
1395،224IR.SSU.REC
Health conditions studied
1
Description of health condition studied
Physiological jaundice
ICD-10 code
P70-P74
ICD-10 code description
XVI Certain conditions originating in the perinatal period
Primary outcomes
1
Description
Neonatal jaundice
Timepoint
Day 1, 3, 5 and 7
Method of measurement
Check out the Billy checker
Secondary outcomes
1
Description
Baby washing
Timepoint
Day 1, 3, 5 and 7
Method of measurement
Biliometer
2
Description
Baby massage
Timepoint
Day 1, 3, 5 and 7
Method of measurement
Biliometer
Intervention groups
1
Description
Bath group were bathed immediately after birth
Category
Prevention
2
Description
massage group for five days,tow times each day , every time for 15 minutes
Category
Prevention
3
Description
the control group received routine care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaie Hospital
Full name of responsible person
Effat Noroozi
Street address
Ziaie Hospital, Teachers' Square, Azadi Square
City
Ardakan
Province
Yazd
Postal code
8915173160
Phone
+98 35 3152 2202
Email
e.noroozi@ssu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mehrdad Mansoori
Street address
Yazd University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Effat Noroozi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
, Faculty of Nursing and Midwifery, Bouali Alley, Tayyasar Fallahi St., Safayeh Yazd,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3152 2202
Fax
Email
e.noroozi@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Effat Noroozi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
, Faculty of Nursing and Midwifery, Bouali Alley, Tayyasar Fallahi St., Safayeh Yazd,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
e.noroozi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Effat Noroozi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
, Faculty of Nursing and Midwifery, Bouali Alley, Tayyasar Fallahi St., Safayeh Yazd,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3152 2202
Fax
+98 35 3152 2113
Email
e.noroozi@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will be available to researchers working in academic and academic institutions and students
Under which criteria data/document could be used
Data is available for students to help investigate similar projects while retaining the contents
From where data/document is obtainable
To receive data at e.noruozi@yahoo.com
And call the phone 09132517951
What processes are involved for a request to access data/document
After receiving the application for data, the applicant will be provided with the documentation within two days