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Influence of self-care education on Multiple Sclerosis patients` adaptation

Protocol summary

Summary
The purpose of this research was to study the influence of self- care education on adaptation of multiple sclerosis patients. The inclusion criteria were age between 20 to 65 years, educational level of elementary school and higher, not dependent to wheelchair, not being in acute phase of the disease, residence in Arak, willing to participate in the study, member of Multiple Sclerosis Association of Markazi province; and the exclusion criteria were patient's failure in cooperation and death. In this research, 50 eligible patients referring to Multiple Sclerosis Association were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups. The intervention was performed in five, 45 minutes sessions for 5 weeks; in the form of face to face education, practical presentation and answering questions, as well as providing educational materials. The data was gathered in three levels; before intervention, one week and four weeks after intervention in the two groups. The initial outcome was adaptation and the secondary outcome was the improvement of social relations.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015100224290N1
Registration date: 2016-04-12, 1395/01/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-12, 1395/01/24
Registrant information
Name
Zohreh Farahani
Name of organization / entity
Arak Medical University
Country
Iran (Islamic Republic of)
Phone
+98 86 3497 2718
Email address
z.farahani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Arak University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of self-care education on Multiple Sclerosis patients` adaptation
Public title
Effectiveness of self-care education on Multiple Sclerosis patients` adaptation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:20-65 years old; educational degree of elementary school and higher; independency on wheelchair; the period of disease not being in serious step of diseases; residence in Arak; having capability and enthusiasm to participation in analysis; aware consent to participation in research; membership in Markazi Multiple Sclerosis Association. Exclusion criteria: failure in pursuing the educational program; death; patient's dis-cooperation.
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization method, a random number table.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak .University of Medical Sciences
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street , Arak
City
Arak
Postal code
Approval date
2015-06-29, 1394/04/08
Ethics committee reference number
ir.arakmu.rec.1394.81

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
adaptation
Timepoint
Before the intervention, after the intervention, 4 weeks after intervention
Method of measurement
Social Adaptation Questionnaire

Secondary outcomes

1

Description
Probable relation
Timepoint
Before the intervention, after the intervention, 4 weeks after intervention
Method of measurement
Social Adaptation Questionnaire

Intervention groups

1

Description
Intervention group:Education in the field of self-care in Multiple Sclerosis patients was performed in five 45-minute sessions in the form of face to face education, question- answer and presentation of educational booklet. It included the familiarity with Multiple Sclerosis disease, self-care education in terms of urinary disorders, self-care education on fatigue and improvement of balance, and also self-care education in the field of spasm and muscular weakness.
Category
Lifestyle

2

Description
Control group: didn't undergo any treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
MS Society of Markazi province
Full name of responsible person
Mr.Amiri
Street address
MS Society of Markazi province, Farabi street, Razavi town, Arak, Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Mr.Babaie
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Sardasht, Arak
City
Arak
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 of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Zohreh Farahani
Position
Bsc in Operating room Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak , Iran
City
Arak
Postal code
Phone
+98 86 3497 2718
Fax
Email
z.farahani@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sharareh khosravi
Position
Assistant Professor
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
shararehkh2011@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zohreh Farahani
Position
Bsc in Operating Room Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street Arak, Iran
City
Arak
Postal code
Phone
+98 86 3497 2718
Fax
Email
z.farahani@arakmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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