Comparison of acute stress persistence in patients with chronic ischemic stroke with healthy individuals
Design
this study will be conducted in the pilot phase because without same study, with 10 healthy individuals in the control group and 10 patients with chronic ischemic stroke. Patients were randomly selected from the list of stroke patients and healthy subjects were selected from relatives of the same patients which were homogenized in terms of age and BMI.
Settings and conduct
eligible patients are called to the hospital and After arriving and obtaining written informed consent ,they should fill the questionnaires on individual characteristics and Spillberger's Anxiety Inventory. Then a saliva sample is taken and the ECG is recorded. Then the person enters the TSST protocol in order to become mildly stressed. After the protocol, the saliva will be obtained immediately and After twenty minutes and forty minutes, salivary sample and ECG tests will be repeated. Finally, the blood sample is taken.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. men with 18 to 70 years old 2.occurrence of ischemic stroke in 6 months to 3 years before the participation which approved by CT scan or MRI 3. Modified Ranking Scale <= 3 in stroke patients 4. Absence of systemic disorders like Diabetes, autoimmune, cardiovascular, neurological or psychiatric disorders 5.No smoking at least one day before the test 6. No severe exercise at least one month before the test
exclusion: no continue participation, unstable condition for general health
Intervention groups
intervention group : patients with chronic ischemic stroke
control group: healthy individuals
Main outcome variables
1. Spillberger Anxiety Test Score
2. Salivary Cortisol levels before testing
3. Salivary Cortisol levels after the test
4. CD Heart Rate Variability
5. The amount of glutathione peroxide
6. The amount of vitamin E
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171128037666N1
Registration date:2018-06-02, 1397/03/12
Registration timing:retrospective
Last update:2018-06-02, 1397/03/12
Update count:0
Registration date
2018-06-02, 1397/03/12
Registrant information
Name
Boshra Hatef
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3225 3495
Email address
boshrahatef@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-03-18, 1396/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of Acute stress persistence in ischemic stroke patients with healthy patients
Public title
Acute stress persistence in ischemic stroke patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
The first inclusion criteria is the incidence of ischemic stroke should be 6 months to 3 years before the study, which approved by CT scan or MRI
The Modified Ranking Scale for chronic stroke patients should be <= 3
The participants should not be disordered with systemic disorders like Diabetes, autoimmune disorders, cardiovascular disorders and neurological or psychiatric disorders.
The participants should not have cigarette smoking at least one day before the study
The participants should not have severe exercise at least one month before the study
Exclusion criteria:
Failure to cooperate in completing test procedures
Age
From 18 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study we use Random number table for randomizing
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baghiatallah University of Medical Sciences
Street address
mollasadra Ave, Vanak sq, Tehran
City
Tehran
Province
Tehran
Postal code
881435916471
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.BMSU.REC.1396.4
Health conditions studied
1
Description of health condition studied
chronic ischemic stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Salivary cortisol levels before and after intervention
Timepoint
Salivary cortisol levels before intervention, immediately after intervention, twenty minutes after intervention and forty minutes after intervention
Method of measurement
The concentration of cortisol in the saliva samples measure in the laboratory by the salivary cortisol assay kit.
Secondary outcomes
1
Description
linear and non-linear features of heart rate variation
Timepoint
linear and non-linear indicators of heart rate fluctuations as a secondary outcome, can be measured immediately before the TSST intervention, during the TSST protocol, twenty minutes after the end of the protocol, and forty minutes after the end of the protocol.
Method of measurement
ECG instrument
Intervention groups
1
Description
Intervention group: People with chronic stroke. Type of intervention: Stress which is generated by the TSST protocol. During this protocol, the person is initially interviewed for 2 minutes by a doctor, and then for 13 minutes, math questions are asked in the form of a subtraction of certain numbers, so that he becomes significantly stressed.
Category
Early detection
2
Description
Control group: age- matched health participants with patients. Type of intervention: Stress which is generated by the TSST protocol. During this protocol, the person is initially interviewed for 2 minutes by a doctor, and then for 13 minutes, math questions are asked in the form of a subtraction of certain numbers, so that he becomes significantly stressed.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuroscience Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Full name of responsible person
Omid Mirzaee
Street address
mollasadra Ave, Vanak Sq, Teehran, Iran
City
Tehran
Province
Tehran
Postal code
881435916471
Phone
+98 21 8804 0060
Email
boshrahatef@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
boshra hatef
Street address
mollasadra ave, vanak sq, tehran
City
Tehran
Province
Tehran
Postal code
881435916471
Phone
+98 21 8804 0060
Email
boshrahatef@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Boshra Hatef
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
mollasadra Ave, Vanak sq, Tehran
City
Tehran
Province
Tehran
Postal code
881435916471
Phone
+98 21 8804 0060
Email
boshrahatef@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Boshra Hatef
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Baghiatallah University, mollasadra Ave, Vanak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
881435916471
Phone
+98 21 8804 0060
Email
boshrahatef@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Omid Mirzaee
Position
general physician
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
baghiatallah university, mollasadra ave, vanak sq, tehran
City
Tehran
Province
Tehran
Postal code
881435916471
Phone
+98 937 614 9146
Email
omirzaee@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all data are shareable after recognizing the individuals
When the data will become available and for how long
Start the access period from 1400
To whom data/document is available
Only researchers working in universities
Under which criteria data/document could be used
No more information
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document