Comparing of the effect of foot reflexive massage and tactile stimulation on consciousness levels and physiological indices of traumatic brain injury patients admitted to Intensive care unit
Comparing of the effect of foot reflexive massage and tactile stimulationon on consciousness levels and physiological indices of tromatic brain injery patients
Design
This study is a clinical trial.The study population included all traumatic brain injery patients in the ICU. 60 eligible patients selected conveniently and randomly assigned to four groups (three intervention and one control group)
Settings and conduct
This study, carried out at selected Hospital in Qazvin city for two weeks ,twice a day,11:00 am & 15:00 pm. before and after intervention, the level of consciousness, vital signs, and arterial oxygen saturation in all for groups recorded in a checklist.
Participants/Inclusion and exclusion criteria
Patients is hospitalized with head trauma (Types of brain hematomas and diffuse axon damage).
The patient has pupil reflexes at the entrance to the ICU section.
The patient already has no history of GCS fluctuations within a few days prior to the trauma.
The patient already has no history of Diabet.
Intervention groups
First intervention group 20 minutes feet massage daily, second intervention group 20 minutes hand touch daily, third intervention group 20 minutes feet massage and 20 minutes hand touch daily were done, forth group (control group) not received any intervention.
Main outcome variables
feet massage, hand touch, blood pressure, level of consciousness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180726040604N1
Registration date:2018-09-22, 1397/06/31
Registration timing:retrospective
Last update:2018-09-22, 1397/06/31
Update count:0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Bagheiatallah Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 3236
Email address
icusalehi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-03-21, 1397/01/01
Trial completion date
2018-03-21, 1397/01/01
Scientific title
Comparing of the effect of foot reflexive massage and tactile stimulation on consciousness levels and physiological indices of traumatic brain injury patients admitted to Intensive care unit
Public title
The effect of foot reflexive massage and tactile stimulation on consciousness levels and physiological indices of traumatic brain injury patients admitted to Intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients is hospitalized with head trauma (Types of brain hematomas and diffuse axon damage).
The patient has pupil reflexes at the entrance to the ICU section.
The patient already has no history of mental illness, GCS fluctuations within a few days prior to the trauma.
The patient already has no history of Diabet.
Exclusion criteria:
History of Diabet
History of Coma
Narcotic addiction
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is block randomization and patients are classified into four groups by block random allocation method.
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 Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2017-12-27, 1396/10/06
Ethics committee reference number
IR.QUMS.REC.1396.346
Health conditions studied
1
Description of health condition studied
Brain injery
ICD-10 code
T06
ICD-10 code description
Injuries of brain and cranial nerves with injuries of nerves and spinal cord at neck level
Primary outcomes
1
Description
The level of consciousness, vital signs, and arterial oxygen saturation
Timepoint
Everyday before and after intervention
Method of measurement
Glasco Coma Scale
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 10 minutes wrists and palms hand touch twice a day ,11:00 am and 15:00 pm , for two weeks
Category
Rehabilitation
2
Description
The second intervention group will receive 10 minutes feet massage from the wrist to the fingers,twice a day,11:00 am and 15:00 pm, for two weeks.
Category
Rehabilitation
3
Description
The Third intervention group will receive 10 minutes wrists and palms hand touch and 10 minutes feet massage from the wrist to the fingers, twice a day,11:00 am and 15:00 pm, for two weeks.
Category
Rehabilitation
4
Description
The control group will not receive any sensory stimulation.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaee Hospital
Full name of responsible person
علی طارمیها
Street address
No. 1, Padegan Ave
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 5800
Email
hosrajaee@qums.ac.ir
Web page address
http://hosrajaee.qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Manochehr Mahram
Street address
Bahonar Blvd.,
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3337 5518
Fax
+98 28 3337 7089
Email
chancellor@qums.ac.ir
Web page address
http://qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Baghiatallah Salehi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bahonar Ave.Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3336 5001
Email
b.salehi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Baghiatallah Salehi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences، Bahonar Blvd.,
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3336 5001
Email
b.salehi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
بقیه اله صالحی
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd.,Qazvin University of Medical Sciences, Qazvin,
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 8034
Email
b.salehi@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD