Investigating and comparing the stress response system in terms of hormonal responses and heart rate fluctuations to acute stress in MS patients before and after TSST intervention
Design
There is a group of MS patients in this study. These patients are examined five minutes before TSST (acute social stress intervention) and five minutes after salivary cortisol and heart rate intervention.
Settings and conduct
this study will be conducted in Kashani hospital affiliated to Isfahan University of medical sciences. The protocol and procedure of study will be explained and patients will be enrolled and written informed consent will be obtained. A single neurologist, a technician with a specialist with the procedure of study, and the statistical analyzer will be conducted in the study. all of them will be trained before the study by PI. In the control group (healthy people), all the above principles are observed in the same way.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people between the ages of 20-50 years. Do not have systemic diseases such as DM, HTN, cardiovascular disease, and other autoimmune diseases. Do not smoke until the day before the intervention. The time of diagnosis is between 6 months and 5 years and the definitive diagnosis of MS is made by a neurologist. Exclusion criteria: dissatisfaction with participation in the study.
Intervention groups
acute stress intervention by the TSST test.
Main outcome variables
Salivary cortisol level ؛ Heart rate variations
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171128037666N2
Registration date:2020-04-05, 1399/01/17
Registration timing:prospective
Last update:2020-04-05, 1399/01/17
Update count:0
Registration date
2020-04-05, 1399/01/17
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
2020-05-12, 1399/02/23
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the stress response system before and after the trait social stress test (TSST) in multiple sclerosis patients
Public title
Comparison of stress system in patients with multiple sclerosis before and after TSST intervention
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of MS
The duration of illness ranged from 6 months to 5 years
The age range is 20-50 years
No smoking during the last day
Exclusion criteria:
Having systemic diseases such as DM, HTN, cardiovascular disease, autoimmune diseases
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Nasiri street, Mollasadra, Vanak
City
Tehran
Province
Tehran
Postal code
881435916471
Approval date
2019-09-21, 1398/06/30
Ethics committee reference number
IR.BMSU.REC.1398.277
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
salivary cortisol level
Timepoint
Before and immediately after intervention
Method of measurement
ELISA kit
2
Description
Heart rate variation features
Timepoint
Before and immediately after intervention
Method of measurement
signal processing of ECG
Secondary outcomes
empty
Intervention groups
1
Description
the social stress test (TSST) use to induce stress. The period of induced stress lasts approximately 10 minutes and is divided into 5-minute components. Participants will talk about their job during the first 5 minutes of the test. The judges have been trained to maintain neutral expressions throughout the test. The presentation is immediately followed by the mental arithmetic component, during which the participant is asked to count backward from 1,022 in steps of 13. If a mistake is made, then they must start again from the beginning. This component lasts for 5 minutes and is followed by a recovery period. We will measure salivary cortisol and heart rate by ECG.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hosipital
Full name of responsible person
Vahid Shaygannejad
Street address
Kashani straat
City
esfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3323 9900
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
ملاصدرا
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3131
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
Physiotherapy
Street address
Aghdasie
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 71 3225 3495
Fax
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
Physiotherapy
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
Boshra Hatef
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
mollasadra Ave, Vanak sq, Tehran
City
Tehran
Province
Tehran
Postal code
881435916471
Phone
+98 21 8804 0060
Email
boshrahatef@bmsu.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