Protocol summary

Summary
The aim of this study was to investigate the effect of tactile kinetic stimulation on physical development, reflex state and motor development in preterm neonates. So, among all of the preterm neonates of Amiralmomenin hospital neonatal unit of Semnan city, 40 neonates and their mothers selected purposefully and randomly divided to experimental and control groups. Then, mothers of experimental group conducted tactile kinetic stimulation on neonates to completion of fetal period (40 weeks gestation) for 20 minutes and three times a day whereas, control group received only usual care. The results showed tactile kinetic stimulation led to significant improvement in physical development of experimental group compared to the control group. Moreover, reflex state of the neonates in both groups there was no significant difference. While, motor development of neonates in the experimental group at end of intervention and after 4 months, significantly better than the control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012318945N4
Registration date: 2017-03-11, 1395/12/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-11, 1395/12/21
Registrant information
Name
Mansoureh Mokaberian
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 5399
Email address
mokaberian@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tactile-kinesthetic stimulations through mother on physical development, reflex state and motor development in preterm neonates of neonatal unit
Public title
The effect of massage on physical development, reflex state and motor development in preterm neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a Persian race; not admitted to neonatal intensive care unit during the investigation; there was no history of genetic disease; psychiatric and addiction in the mother; gestational age 32- 37 weeks and Apgar score in first and fifth minutes later than 7 in neonates. Exclusion criteria: the need for medical interventions on neonates; the incidence of symptoms of skin disease and infectious disease in neonates; unstable and irregular heart rat; do not touch techniques work for at least two consecutive times and unwillingness to continue cooperation.
Age
No age limit
Gender
Female
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basij Blvd, Semnan
City
Semnan
Postal code
Approval date
2014-12-02, 1393/09/11
Ethics committee reference number
2889

Health conditions studied

1

Description of health condition studied
preterm neonate
ICD-10 code
060
ICD-10 code description
Preterm delivery without spontaneous labour

Primary outcomes

1

Description
Physical development
Timepoint
Before intervention and after completion of fetal period (40 weeks gestation)
Method of measurement
Antropometric measures

2

Description
Rerlex
Timepoint
Before intervention and after completion of fetal period (40 weeks gestation)
Method of measurement
Brazelton test

3

Description
Motor development
Timepoint
After completion of fetal period (40 weeks gestation) and 4 months after intervention
Method of measurement
Peobody test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: phase 1 and 3: tactile stimulation; phase 2: kinetic stimulation
Category
Treatment - Other

2

Description
Control group: Receiving usual care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital of Semnan
Full name of responsible person
Mansoureh Mokaberian
Street address
MostafaKhomeini Blvd, Semnan
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Semnan University of Medical Sciences
Full name of responsible person
Dr. Rashidipoor
Street address
Basij Blvd, Semnan
City
Semnan
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 of Semnan 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
Shahrood University of Technology
Full name of responsible person
Mansoureh Mokaberian
Position
Assistant Professor
Other areas of specialty/work
Street address
Daneshgah Blvd, Shahrood
City
Shahrood
Postal code
Phone
+98 23 3346 5013
Fax
Email
mokaberian@shahroodut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr.Shamsolah Nooripoor
Position
Pediatric group
Other areas of specialty/work
Street address
Basij Blve, Semnan
City
Semnan
Postal code
Phone
+98 23 3344 8996
Fax
Email
sh.noripour@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Mansoureh Mokaberian
Position
Assistant Professor
Other areas of specialty/work
Street address
Daneshgah Blve, Shahrood
City
Shahrood
Postal code
3619995161
Phone
+98 23 3346 5013
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...