Tactile kinesthetic stimulation (TKS) in newborns has been shown to be effective in many studies, but applying this method by their mothers has adequately not been studied. Due to the rule of mother in care of her neonate, effect of TKS on anthropometric measurements of preterm infants, with home visit, will be evaluated in this study. In a randomize controlled trial, in Shahid Akbarabadi treatment & education center, 60 Iranian preterm infants who will be discharged from neonatal intensive care unit (NICU) to home, will be allocated to control or intervention group. Each mother will be directly trained by researcher at the time of discharge, and guideline book will be given to them. TKS will be performed by trained mother from the time of discharge until term corrected age. Home visiting program will be done twice weekly by researcher. Weight, height, head and chest circumference measurements of newborns in time of discharge will be compared to these measurements at term corrected age. All measurements will be taken before and after intervention in two groups, on the same equipment and by the same blind observer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903092324N5
Registration date:2011-01-30, 1389/11/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-30, 1389/11/10
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
School of Nursing and Midwifery, Tehran Uiversity of Medical Sciences
Expected recruitment start date
2010-07-14, 1389/04/23
Expected recruitment end date
2010-09-14, 1389/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Tactile Kinesthetic Stimulation by mother on anthropometric measurements of discharged preterm newborns, with home visit program
Public title
Effect of Tactile Kinesthetic Stimulation by mother, on anthropometric measurements of preterm newborns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1) Birth weight >1500 g and/or gestational age ≥32 weeks; 2) Appropriate for gestational age (AGA); 3) Exclusive breastfeeding. 4) Apgar score ≥ 7 at 1 and 5 minutes with no resuscitation required at birth; 5)no congenital anomalies; 6) single pregnancy; 7) No history of addiction in mother; Exclusion criteria: 1) Existing medical or surgical problem during intervention and hospitalization; 2) No given stimulation for two times in a couple of days; 3) no exclusive breast feeding.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
School of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Postal code
Approval date
2010-05-31, 1389/03/10
Ethics committee reference number
1725812
Health conditions studied
1
Description of health condition studied
anthropometric measurements of preterm infants
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
weight
Timepoint
Term corrected age
Method of measurement
Weight will be taken without clothes on an electronic weighing scale with an accuracy of ± 10 grams.
2
Description
Head circumference
Timepoint
Term corrected age
Method of measurement
Head circumference will be measured with a non-stretchable cloth-tape
3
Description
chest circumference
Timepoint
Term corrected age
Method of measurement
chest circumference will be measured with a non-stretchable cloth-tape
4
Description
Height
Timepoint
Term corrected age
Method of measurement
Height will be measured with an infant meter
Secondary outcomes
empty
Intervention groups
1
Description
The intervention is provided for three 20 min periods per day. Intervention comprises three phases. During the tactile stimulation in phase 1 and 3 (8 min in each phase), the infant is placed in a left and right lateral position and stroked with moderate pressure. Six strokes at approximately 10 s per stroking motion over each region in the following body region:(a) Head (b) shoulder (c) hand (d) back (E) leg. During the Kinaesthetic stimulation phase, the infant is placed in a supine position, then legs and arms are flexed and extended. (a) right arm, (b) left arm, (c) right leg, (d) left leg, Six motions at approximately 10s for each flexion and extension.
Category
Prevention
2
Description
TKS will not be taken for control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi treatment & education center
Full name of responsible person
Maryam Keshavarz
Street address
Molavi Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Vice chancellor for research
Street address
Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing and Midwifery, 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
Nursing and Midwifery, Tehran 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
+98 21 8879 3805
Email
Keshavarz_m@tums.ac.ir , m_keshir@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery, Tehran 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, Tehran University of Medical Sciences, Rashid Yasami St. Valiasr Ave, Box: 19395-4798
City
Tehran
Postal code
Phone
+98 21 8247 1406
Fax
+98 21 8879 3805
Email
keshavarz_m@tums.ac.ir , m_keshir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran 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, Tehran 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
+98 21 8879 3805
Email
Keshavarz_m@tums.ac.ir , m_keshir@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)