Study Effect Of Massage Therapy With Or Without Exerciseson The Weight Gain premature Hospitalized In pediatric Ward .
Design
Intrevention Study ,control Group,Randomise
Settings and conduct
This Study performed on 45 low birth weight neonates hospitalized in pediatric ward of Shoohada Hospital divided 3 Groups.each Groups consist 15 infants.Massage Group received Massage with Olives oil twice a day for 15 minutes in 5 days.(after Feeding ).and Massage and exercises groups in Addition of massage were done in form of extention and flextion for 5 minutes.the Massage and Exercises was done By Reasercher. infants weight was measured and Recorded By a Assistant Reasercher with constant of Measuring scale befor intervention and Fifth Day (the end of intervention).
Participants/Inclusion and exclusion criteria
Birth weight lower than 2500grams,gest/age30 t0 36 weeks
Intervention groups
3Groups consist control group,Massage group and Massage and exersices group
Main outcome variables
Birth weight;gestational Age and weight befor study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170520034039N3
Registration date:2018-05-18, 1397/02/28
Registration timing:retrospective
Last update:2018-05-18, 1397/02/28
Update count:0
Registration date
2018-05-18, 1397/02/28
Registrant information
Name
Rokhsareh Barati
Name of organization / entity
Shiraz university of medical scince
Country
Iran (Islamic Republic of)
Phone
+98 917 169 9948
Email address
barati_r@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-10-13, 1395/07/22
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
2016-10-13, 1395/07/22
Actual recruitment end date
2017-02-19, 1395/12/01
Trial completion date
empty
Scientific title
Comparison of the Effect of Massage Therapy With or Without Physical Exercises on the weight gain of Premature Infants.
Public title
Study Effect of Massage Therapy With or Without Physical Exercises on the weight gain Premature Infants.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Too Agreement Of Parentes
Gestational Age 30-36 Weeks
Lake of Evidence for Congenital Disorder
Birth Weight Lower Than 2500 gram
Breast Feeding
Iranian Nationality
Age Above 1 week
Exclusion criteria:
Congenital Disorder
Age
From 7 days old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Qualify Infants divided in to three groups of massage, massage by exercises and control group with random number tables(Permutation block).researcher formed different Permutions.(a:Massage),(b:Massage with exercises)and (c:control).then for selection to put the her finger from a site from number tabels to column and row. she write down related permutation when observed number1-9.
Blinding (investigator's opinion)
Single blinded
Blinding description
Infants weight was measured and recorded by a recorder who didnt know anything about group divisions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic commitee of Shiraz University of Medical Sciences
Street address
Zand Ave, Medical Scince Centra Buldg
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2016-07-20, 1395/04/30
Ethics committee reference number
IR.sums.rec.1395.86
Health conditions studied
1
Description of health condition studied
low birth weight
ICD-10 code
p07
ICD-10 code description
Disorders of newborn related to short gestation and low birth weight, not elsewhere classified
Primary outcomes
1
Description
infant weight
Timepoint
Before intervention and end of study
Method of measurement
By spicific scale
Secondary outcomes
empty
Intervention groups
1
Description
Massage Group recived Massage by olives oil (sufra, yellowish) after breakfast and lunch for 15 minutes for consecutive days,by a researcher .
Category
N/A
2
Description
Massage and exercises group (2)in addition of massage ,exercises stimulation were done in form of extension and flexion for 5 minutes
Category
N/A
3
Description
Control group ricived any intervention .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital Of Bandare Lengeh
Full name of responsible person
Rokhsareh Barati
Street address
Shohada Hospital,Hosein Abad Ave.
City
Bandar Lengeh
Province
Hormozgan
Postal code
79781
Phone
+98 76 4422 2421
Email
rokhsareh@barati.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of shiraz
Full name of responsible person
Dr Seyed Baser Hashemi
Street address
Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 1235 7282
Fax
Email
verdp@sums.ac.ir
Grant name
95-7673
Grant code / Reference number
ir.sums.Rec.1395.86
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of shiraz
Proportion provided by this source
80
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
2
Sponsor
Name of organization / entity
The Unevercity of Shiraz
Full name of responsible person
Dr Seyed Baser Hashemi
Street address
Zand street ,Shiraz
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 1235 7282
Fax
Email
verdep@sums.ac.ir
Grant name
95-7673
Grant code / Reference number
ir.sums.rec.1395.86
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Unevercity of Shiraz
Proportion provided by this source
80
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
The University of Shiraz,
Full name of responsible person
Edraki Mitra
Position
Instructor of Department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Namazi Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
edrakim@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Uneversity of Shiraz
Full name of responsible person
Montasere Sedighe
Position
instractor of pediatric department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
College of Nursing and Midwifery Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
+98 21 3647 4252
Email
Montaseris@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The Uneversity of Shiraz
Full name of responsible person
Rokhsareh Barati
Position
Student of Master of Neonatology Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz ,Nursing College
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 76 4422 2421
Fax
Email
barati_r@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
part of data
When the data will become available and for how long
8 month after publish
To whom data/document is available
Reaserchers
Under which criteria data/document could be used
Request to shiraz university of medical scinces
From where data/document is obtainable
rokhsareh .barati (barati.rokhsareh@gmail.com)
What processes are involved for a request to access data/document