Objective: Effect of relaxation on pain, fatigue and quality of life in women with multiple sclerosis. Design: Randomized clinical trial at two groups of intervention and control. The studied population: Patients of woman with multiple sclerosis who will refer to MS Association, Sample population: 70 people at two groups of intervention and control. Setting: patients with multiple sclerosis who will refer to MS Association with following criteria to be studied: (a) definite diagnosis of multiple sclerosis by neurologist; (b) age 20-45; (c) do not have acute illness; (d) EDSS (Expanded Disability Status Scale) is equal or less than 4/5; (e) to have pain and fatigue symptoms. The patients will be excluded from the study with the following criteria: (a) being disable to continue for participating in sessions for any reason; (b) being hospitalized. Interventions: relaxation will be done in way of Jacobson on 12 sessions of forty to sixty minutes, during four weeks at intervention group. Patients will be received routine cares at control group. Measurement of main outcome: pain, fatigue and life’s quality will be studied in accordance with questionnaires as follows: (a) pain will be evaluated by visual pain scale before and eight weeks after intervention; (b) fatigue will be evaluated in accordance with fatigue severity scale questionnaire before and eight weeks after intervention; (c) life’s quality will be evaluated in accordance with 54 items questionnaire of life’s quality of multiple sclerosis patients before and eight weeks after intervention.
General information
Acronym
ms
IRCT registration information
IRCT registration number:IRCT201302109759N3
Registration date:2013-04-01, 1392/01/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-01, 1392/01/12
Registrant information
Name
Ali Bikmoradi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0439
Email address
bikmoradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice_chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-03-10, 1391/12/20
Expected recruitment end date
2013-05-10, 1392/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of relaxation on pain, fatigue and quality of life in women with multiple sclerosis
Public title
Effect of relaxation on Patients with multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: (a) certain diagnosis of multiple sclerosis by neurologist; (b) age between 20-45; (c) not to be in acute phase of disease; (d) EDSS (Expanded Disability Status Scale) which is equal or less than 4/5 according to neurologist's view; (e) to have pain and fatigue symptoms. Exclusion criteria: (a) lack of ability to participate in the relaxation sessions for any reason; (b) to be hospitalized in hospital.
Age
From 20 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the balanced block randomization will be used and the patients allocated in two groups of intervention (body relaxation) and control (routine cares).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Human Subject Review Board of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838698
Approval date
2013-02-14, 1391/11/26
Ethics committee reference number
4025/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
pain
Timepoint
Before and after intervention
Method of measurement
Visual pain Scale
2
Description
Fatigue
Timepoint
Before and after intervention
Method of measurement
Fatigue Severity Scale for patient with multiple sclerosis
3
Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
MSQoL-54 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: in the control group the patients will be received only routine cares.
Category
Other
2
Description
Intervention group: relaxation will be done in way of Jacobson under 12 forty to sixty minute sessions during four weeks at intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Association for Support of Patients with Multiple Sclerosis
Full name of responsible person
Azadeh Zafari
Street address
Shahid Fahmideh Ave., School of Nursing and Midwifery, Hamadan University of Medical Sciences
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Tavilani
Street address
Shaheed Fahmideh Ave., Hamadan University of Medical Sciences,
City
Hamadan
Grant name
از محل یک درصد بودجه طرح های تحقیقاتی دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research and Technology, Hamadan 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
Hamadan University of Medical Sciences, Nursing and Midwifery School
Full name of responsible person
Dr. Ali Bikmoradi
Position
Medical Education Management
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838698
Phone
+98 81 1838 0439
Fax
+98 81 1838 0447
Email
bikmoradi@umsha.ac.ir;abeikmoradi@yahoo.com
Web page address
www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Ali Bikmoradi
Position
PhD of Medical Education Management
Other areas of specialty/work
Street address
Hamadan University of Medical Science, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838698
Phone
+98 81 1838 0439
Fax
+98 81 1838 0447
Email
bikmoradi@umsha.ac.ir; abeikmoradi@yahoo.com
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences, Nursing and Midwifery School
Full name of responsible person
Dr.Ali Bikmoradi
Position
PhD of Medical Education Management
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences,Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838698
Phone
+98 81 1838 0439
Fax
+98 81 1838 0447
Email
bikmoradi@umsha.ac.ir; abeikmoradi@yahoo.com
Web page address
www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)