To determine the effects of 5 days of massage therapy on physiologic parameters and weight gaining of hospitalized stable preterm infants hospitalized in Fatemiye neonatal intensive care unit in Shahrood-Iran. Fifty one babies will be randomly allocated into test and control groups (27 and 24 neonate respectively). Tactile-Kinesthetic stimulation will be provided for three 20 minutes periods per day for 5 consecutive days to the test group, with the massages consisting of moderate pressure stroking in left and right lateral position and kinesthetic exercises consisting of flexion and extension of the limbs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805192324N1
Registration date:2006-06-20, 1385/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2006-06-20, 1385/03/30
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrod University of medical Sciences
Expected recruitment start date
2006-06-20, 1385/03/30
Expected recruitment end date
2007-01-20, 1385/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Tactile-Kinesthetic Stimulation on weight gaining of preterm infants
Public title
Effect of Tactile-Kinesthetic Stimulation on weight gaining of preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age 28 to 37 weeks, birth weight over 1500 gr, appropriate-for-gestational-age (AGA), apgar scores ≥7 at 1 and 5 min. No undergoing mechanical ventilation, congenital anomalies, central nervous system dysfunction (e.g., intraventricular hemorrhage or history of seizure), necrotizing enter colitis (NEC), sepsis, history of maternal drug abuse including: alcohol or illegal substances (as determined by the mother`s reported history or medical records). Infants will be excluded if they had such as hiccup, facial grimace, finger splay, clenched fingers, crying, heart rate over 200, intervention.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrood University of Medical Sciences
Street address
Hafte Tir Square
City
Shahrood
Postal code
Approval date
2005-07-16, 1384/04/25
Ethics committee reference number
8404
Health conditions studied
1
Description of health condition studied
weight gaining of preterm infants
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
weight gaining
Timepoint
daily
Method of measurement
with digital scale
Secondary outcomes
1
Description
Change in physiologic parameters including: Heart rate, Respiratory rate and Temperature
Timepoint
Immediately before intervention and during 20 min intervention
Method of measurement
Palse oximeter
Intervention groups
1
Description
No intervention in control group
Category
N/A
2
Description
Tactile-Kinesthetic Stimulation
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiye treatment & education center
Full name of responsible person
Maryam Keshavarz
Street address
22 Bahman Avenue
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrood University of Medical Sciences
Full name of responsible person
Deputy of research affairs
Street address
Hafte Tir Square
City
Shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrood 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
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery - academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Postal code
19964
Phone
+98 21 8247 1406
Fax
Email
keshavarz@iums.ac.ir , m_keshir@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery - academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Postal code
Phone
+98 21 8247 1406
Fax
Email
keshavarz@iums.ac.ir , m_keshir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery - academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Postal code
Phone
+98 21 8247 1406
Fax
Email
keshavarz@ium.ac.ir , m_keshir@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)