The purpose of this study the effect of massage with sesame and sunflower oils long cry, sleep and infant growth. Study of a triple blind clinical trial that the group in order to compare the effects of massage with sunflower oil, sesame and massage alone on the duration of crying, sleep and growth of 120 infants will take 15 -10 days. Studied for 5 weeks, a week basis (to obtain basic information from the average duration of infant crying and sleep) and four weeks of the intervention will take. Mother Massage by 2 times (morning and afternoon) per day, each time for 15 minutes and 28 days (four weeks) is achieved. For crying, sleep duration, height and weight measurements and infants between the two groups will be compared. "
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102265912N1
Registration date:2012-01-08, 1390/10/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-08, 1390/10/18
Registrant information
Name
Mandana Mir Mohammad Ali Ei
Name of organization / entity
Tehran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
mirmohammad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-04-09, 1389/01/20
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of massage with sunflower oil and sesame oil on crying, sleeping and infant growth
Public title
massage with sunflower oil and sesame oil
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 1) term infants (42-37 ) 2) 3 birth weight 4000-2500 g) singleton 4) fed exclusively with breast milk 5) absence of obvious disease or birth abnormalities 6) the first child of 7 ) minimal maternal Education in secondary school 8) lack of maternal diseases such as hypertension, diabetes, pregnancy, postpartum depression or any psychiatric illness related to maternal 9) no history of hospitalization due to disease, infant 10) lack of separation of infant from mother benchmarks withdrawal from the study: 1) sensitivity to any of the oils used for massage 2) disease public or skin infant during the study, 3) no intervention in four sessions consecutive or intermittent (48 h) 4) failure to complete the application form parents crying baby for 24 hours at least 5) infant feeding with artificial milk, 6) NO mother's illness
Age
From 10 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Review Commiitee of Tehran University of Medical Sciences
Street address
Ghods street, Keshavarz BLD,Central building of Tehran Un
City
Tehran
Postal code
88987381
Approval date
2009-12-21, 1388/09/30
Ethics committee reference number
1388/130/1443
Health conditions studied
1
Description of health condition studied
crying ,sleep and Growth infant
ICD-10 code
z76.2
ICD-10 code description
Health supervision and care of other healthy infant and child
Primary outcomes
1
Description
crying
Timepoint
befor intervention-end the first week-end the the second week-End of the third week and the fourth week
Method of measurement
Daily form of crying parents
2
Description
sleep
Timepoint
befor intervention-end the first week-end the the second week-End of the third week and the fourth week
Method of measurement
Daily form of crying parents
3
Description
Weight
Timepoint
befor intervention-end the first week-end the the second week-End of the third week and the fourth week
Method of measurement
Standard Scales
4
Description
Height
Timepoint
befor intervention-end the first week-end the the second week-End of the third week and the fourth week
Method of measurement
Meter Standard
Secondary outcomes
empty
Intervention groups
1
Description
Massage with sunflower oil and sesame seeds in this study in order to massage with sunflower oil or sesame oil manufacturing company Baryj Essence Kashan was with 10 cc of oil twice a day every 15 minutes for 4 weeks doing be by the mother on the infant
Category
Other
2
Description
Control: In order to study without the use of massage oils twice daily (morning and afternoon) every 15 minutes for 4 weeks will perform by mothers on infant
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center Number 1
Full name of responsible person
Ziba Raisi Dehkordi
Street address
Shahrekord
City
Malat Gharbi
2
Recruitment center
Name of recruitment center
Health Center Number 2
Full name of responsible person
Ziba Raisi Dehkordi
Street address
Shahrekord
City
Shahrekord
3
Recruitment center
Name of recruitment center
Health Center Number 9
Full name of responsible person
Ziba Raisi Dehkordi
Street address
Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Abass Hoshmand Bahabadi
Street address
Nosrat ST.Tohid SQ, Faculty of Nursing and Midwifery
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
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
Tehran University of Medical Siences
Full name of responsible person
Mandana Mrmohammadali
Position
Instructor
Other areas of specialty/work
Street address
Nosrat ST,Tohid Sq, Faculty of Nursing and Midwifery Tehran
City
Tehran
Postal code
Phone
+98 21 6690 4252
Fax
Email
mirmohammad@tums.ac.i
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
Mandana Mirmohammadali
Position
Instructor
Other areas of specialty/work
Street address
Nosrat ST,Tohid Sq, Faculty of Nursing and Midwifery Tehran
City
Tehran
Postal code
Phone
+98 21 6690 4252
Fax
Email
mirmohammad@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
ziba Raisi Dehkordi
Position
Graduate Student
Other areas of specialty/work
Street address
Nosrat St, Tohid Sq, Faculty of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 381
Fax
Email
Raisid@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)