This study was conducted to evaluate the effect of massage on physiological parameters in premature infants in the age group of 28-32 weeks. 135 premature infants who had study criteria’s (gestational age between 28-32 weeks; birth weight between 1000-1500 gram; Apgar score above 7 at 5 minutes) were divided into 3 groups by using simple random method. The first group involved infants who were massaged with olive oil during 10 days and 3 times, 15 minutes per day by their mother. The second group of infants was also above method without the use of massage oil. And the third group of infants did not receive any intervention. During these 10 days, researchers recorded all information such as infant's physiologic parameters and infant's weight daily. Infant weight gain is considered as the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107036918N2
Registration date:2011-10-19, 1390/07/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-19, 1390/07/27
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research, Tabriz University of Medical Sciences
Expected recruitment start date
2010-12-17, 1389/09/26
Expected recruitment end date
2011-03-16, 1389/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Skin Massage on Physiologic Parameters and Outcomes in Preterm Infants
Public title
Effect of Massage
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age infant between 28-32 weeks; Birth weight between 1500 - 1000 gr ; No anomaly, No congenital and systemic disease; No history of mechanical ventilation; No Maternal alcohol, tobacco or drugs ; Apgar score above 7 at 5 minutes; Physiological status of the infant is stabilized (not apnea and is not bradycardia). ; There are no medical contraindications of massage
Exclusion criteria: Now the bad baby; Fever in infants; Lack of mother cooperation to continue; No fill the time of study
Age
To 4 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
Central Is Not Registered in Any
Secondary trial Id
No Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Sciences University of Tabriz
Street address
Deputy of Medical Sciences University of Tabriz
City
Tabriz
Postal code
977-5138947
Approval date
2009-09-28, 1388/07/06
Ethics committee reference number
5147/4/5
Health conditions studied
1
Description of health condition studied
Massage
ICD-10 code
Z00-Z99
ICD-10 code description
Health supervision and care of other healthy infant and child
Primary outcomes
1
Description
Weight
Timepoint
Every Day for 10 Days
Method of measurement
Balance
Secondary outcomes
1
Description
Nosocomial Infection
Timepoint
End of 10 Days
Method of measurement
Blood Cultures
Intervention groups
1
Description
The first group of babies who were three times daily for 10 days and 15 minutes by a mother who had been trained in massage techniques, massage using olive oil.
Category
Prevention
2
Description
Babies in the second group were also three times daily for 10 days and 15 minutes without the use of massage oils.
Category
Prevention
3
Description
Infants in control group received the usual care and did not receive any intervention .
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Educational Center Affiliated Medical Sciences of Tabriz;Iran
Full name of responsible person
Rukiye salimi
Street address
Bagshomal Square;Tabriz;Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
دانشگاه علوم پزشکی
Full name of responsible person
Deputy of Tabriz University of Medical Sciences
Street address
Dr. Reshidi
City
Tabriz University of Medical Sciences
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
دانشگاه علوم پزشکی
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery
Full name of responsible person
Mahnaz Jabreili
Position
MS
Other areas of specialty/work
Street address
Shariety South St; Faculty of Nursing & Midwifery ; Tabriz ; Iran
City
Tabriz
Postal code
34751745
Phone
+98 41 1477 2699
Fax
Email
jabreilim@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)