This study was designed to fine out the effects of tactile stimulation on physical growth and neonatal behavior in low birth weight neonates.This is a Randomized Controlled Trial (RCT) study type that is single blind and without placebo. The study is carried out on LBW neonates in Akbar-abadi hospital of Tehran. The study sample is made out of 40 inborn LBW neonates, who selected simple randomly and divided into control and treatment groups base on stratified.Inclusion criteria included:hospitalized in NICU of Akbar abadi hospital; Birth weight (BW) >1500 g and <2499g ; Medically stable with no requirement of drugs (other than mineral and vitamin supplements), or any specific interventions (with doctor diagnosis) ; Absence of congenital anomalies and neuromuscular disorders (with doctor diagnosis); parents should fill inform consent
exclusion criteria: neonates who their parents tend to excluded their neonates of the study for any reason and any time; if acute physical problems occur during the study, newborn is removed from the sample.
A questionnaire containing information on the general profile of the neonate and neonatal and infancy records to be completed with question of parents and study of medical records by researcher and after Completing the questionnaire,
neuro-behavioral examination to check the status of behavioral and developmental of neonates and assessment of physical growth are done for both groups and the results will be recorded.in the next step,according to a specific protocol, intervention (including the tactile stimulation and passive movements of limbs)is done for the treatment group for 10 days and the results of re-evaluation are compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105016352N1
Registration date:2012-02-25, 1390/12/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-25, 1390/12/06
Registrant information
Name
Faranak Aliabadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
f-aliabadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Tactile-kinesthetic stimulations on neonatal behaviors and physical growth in LBW neonates hospitalized in NICU
Public title
Study of the effect of Tactile-kinesthetic stimulations on neonatal behaviors and physical growth in LBW neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: : hospitalized in NICU of Akbar abadi hospital; Birth weight (BW) >1500 g and <2499g ; Medically stable with no requirement of drugs (other than mineral and vitamin supplements), or any specific interventions (with doctor diagnosis) ; Absence of congenital anomalies and neuromuscular disorders (with doctor diagnosis) ; parents should fill inform consent
Exclusion criteria: neonates who their parents tend to excluded their neonates of the study for any reason and any time; if acute physical problems occur during the study newborn is removed from the sample
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Tehran University of Medical Science-Enghelab square-Tehran-Iran
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
90/ د /260/520
Health conditions studied
1
Description of health condition studied
low birth weight neonates
ICD-10 code
P07.1
ICD-10 code description
Other low birth weight
Primary outcomes
1
Description
weight
Timepoint
at the first and tenth days
Method of measurement
digital scale(gram)
2
Description
infant's behaviors
Timepoint
at the first and tenth days
Method of measurement
Brazelton scale
Secondary outcomes
empty
Intervention groups
1
Description
The massage therapy protocol is done for treatment group for 10 days. massage therapy is begun on the first day of birth and continue for 10 consecutive days. The massage sessions comprised three segments which is two five-minute phases of tactile stimulation and one five-minute phase of kinesthetic stimulation that is given during the middle phase. During tactile stimulation, the neonate is placed in prone position and stroked with the fingers of both hands of therapist for 5, one- minute periods over each region in the following sequence: 1) from the top of the head to the neck , 2) from the neck across the shoulders and back to the neck, 3) from the upper back to the buttocks and revert to the upper back, 4) from the thigh to the foot to the thigh on both legs simultaneously, and 5) from the shoulder to the hand to the shoulder on both arms simultaneously. For the kinesthetic phase, neonate is placed in supine position. This phase consist of six passive flexion/extension movements lasting approximately 10 seconds each. These movements occur in the following sequence: 1) right arm, 2) left arm, 3) right leg, 4) left leg, and 5) both leg simultaneously. Finally tactile stimulation is repeated in third phase.