Stress management is needed in patients with Ms, because stress increases the likelihood of relapse. The purpose of this study is to investigate the effect of educational program based on BASNEF model on behavioral methods of stress management in patients with multiple sclerosis. Present research is a parallel group controlled trial. In this research 100 patients with Multiple sclerosis from Sina and Shariati hospitals are chosen and randomly allocated into the two groups of intervention and control. The instruments for data collecting are a questionnaire based on the BASNEF Model, a check list related to patient practice on the basis of self reporting. Then an educational program are designed and executed on Basnef model in the experimental group for a period of one month. The control group did not receive the education. Model ingredients such as attitude, subjective norms, enabling factors, intention, and behavior are conducted after one month in both groups. Inclusion criteria: proven MS disease, those who fully complete the questionnaires and participate in the educational sessions, those who do not have anxiety and depression. Exclusion criteria: having acute diseases. Patients in the intervention group will participate in 3 educational sessions during a one month period. Behavioural methods of stress management will be taught according to group and individual sessions in the intevention group. Educational items of stress management have been obtained from national Ms Society and have been translated. Educational booklet and a CD named “RAZ” will be given to the participants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011154570N2
Registration date:2010-12-09, 1389/09/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-09, 1389/09/18
Registrant information
Name
Farbod Ebadi
Name of organization / entity
Faculty of public health, Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 8691
Email address
dr_febadi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor for research; Tehran (iran) university of medical science
Expected recruitment start date
2010-04-10, 1389/01/21
Expected recruitment end date
2010-06-24, 1389/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Program Based on BASNEF Model on behavioral methods of stress management in patients with multiple sclerosis
Public title
The Effect of Educational Program Based on BASNEF Model on behavioral methods of stress management in patients with multiple sclerosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: proven MS disease, those who fully complete the questionnaires and participate in the educational sessions, those who do not have anxiety and depression. Exclusion criteria: having acute diseases
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Tehran(iran) University of Medical Sciences and health services
Street address
Iran University of Medical Science; hemmat exp.way
City
tehran
Postal code
Approval date
2010-03-21, 1389/01/01
Ethics committee reference number
پ/26/د5/446
Health conditions studied
1
Description of health condition studied
patients with multiple sclerosis
ICD-10 code
G35
ICD-10 code description
G35; Multiple sclerosis
Primary outcomes
1
Description
attitude
Timepoint
Before the intervention and one month after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Subjective Norms
Timepoint
before the intervention and one month after intervention
Method of measurement
questionnaire
2
Description
Enabling Factors
Timepoint
before the intervention and one month after intervention
Method of measurement
questionnaire
3
Description
intention
Timepoint
before the intervention and one month after intervention
Method of measurement
questionnaire
4
Description
behavior
Timepoint
before the intervention and one month after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Patients in the intervention group will participate in 3 educational sessions during a one month period. Behavioural methods of stress management will be taught according to group and individual sessions in the intevention group. Educational items of stress management have been obtained from national Ms Society and have been translated. Educational booklet and a CD named “RAZ” will be given to the participants.
Category
Prevention
2
Description
The control group did not receive the education program
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
sina and Shariati hospital
Full name of responsible person
Faride Gldoost Marandy , Master of health education; Tehran university of medical science.
Street address
3044-blok 5-phaz 2-Shahrak Ekbatan
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research; Tehran(iran) University of Medical Sciences
Full name of responsible person
Roghaye malmir
Street address
Iran University of Medical Sciences; Hemmat exp.way
City
Tehran
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; Tehran(iran) 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
Tehran(iran) University of Medical Sciences and health services
Full name of responsible person
Farbod Ebadi fard azar
Position
PHD_professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences; Hemmat exp.way
City
Tehran
Postal code
Phone
+98 21 8805 8691
Fax
Email
dr_febadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of health,Tehran(iran) University of Medical Sciences
Full name of responsible person
Faride Gldoost Marandy
Position
Ms student
Other areas of specialty/work
Street address
Argentine square-Alvand street-Faculty of health,Tehran(iran) University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
Goldoost_f@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of health,Tehran(iran) University of Medical Sciences
Full name of responsible person
Faride Gldoost Marandy
Position
Ms student
Other areas of specialty/work
Street address
Argentine square-Alvand street-Faculty of health,Tehran(iran) University of Medical Sciences
City
Tehran
Postal code
Phone
+98 88779118
Fax
Email
Goldoost_f@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)