1-Objective: this study is a randomized clinical trial on 80 patients with multiple sclerosis effect of individual empowerment program on self-efficacy and quality of life in patients with multiple sclerosis deal. 2. Design: After obtaining informed consent, eligible patients were randomly assigned to two groups. 3. Empowerment intervention is done within 8 weeks. Inclusion criteria: 1-Being in the age range 50 to 15 years old. 2-Willingness to participate in research. 3-Persian literate enough to read and write. 4-Not having an approved mental illness and mental retardation, chronic diseases (the doctor).5- follow-up telephone access to the curriculum by the investigator. 6 - At least 6 months of diagnosis is past. 7-No recurrence within 30 days. The exclusion criteria: 1-Company experience in similar training programs in conjunction with research. 2- Unwillingness to continue the study. 3-Faced with extreme stress in the last month. 4-Conditions or diseases that are subject to changes in physical function.5-About the effects of drug use. 6-Participate in all training sessions. 7-Not in the acute phase.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081818846N1
Registration date:2015-01-04, 1393/10/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-04, 1393/10/14
Registrant information
Name
Marziye Nooraei
Name of organization / entity
Fatemehe School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 71 1732 1016
Email address
nooraei_m@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2014-01-14, 1392/10/24
Expected recruitment end date
2014-03-05, 1392/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of individual empowerment program on self efficacy and quality of life in patients with multiple sclerosis
Public title
Effect of individual empowerment program on self efficacy and quality of life in patients with multiple sclerosis referring to shiraz multiple sclerosis society-1392
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1-Being in the age range 50 to 15 years old. 2-Willingness to participate in research. 3-Persian literate enough to read and write. 4-Not having an approved mental illness and mental retardation, chronic Vsayrbymaryhay (the doctor). 5- follow-up telephone access to the curriculum by the investigator. 6 - At least 6 months of diagnosis is past. 7-No recurrence within 30 days . The exclusion criteria:1-Company experience in similar training programs in conjunction with research. 2- Unwillingness to continue the study. 3-Faced with extreme stress in the last month. 4-Conditions or diseases that are subject to changes in physical function. 5-About the effects of drug use. 6-Participate in all training sessions. 7-Not in the acute phase.
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:
80
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
Shiraz University of Medical Sciences
Street address
7th floor, Central Building of Shiraz University of Medical Sciences
City
shiraz
Postal code
1978-71345
Approval date
2014-01-13, 1392/10/23
Ethics committee reference number
92-6845
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
Quality of life
Timepoint
pre intervention, one month after intervention, two month after intervention
Method of measurement
Quality of Life Questionnaire
2
Description
Self efficacy
Timepoint
Pre intervention, one month after intervention, two month after intervention
Method of measurement
Questionner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: for intervention groups, family centered empowerment model with four steps and four dimensions, the perceived threat (severity and sensitivity), self-efficacy, and self-evaluation during 8 session of 45 minutes for 8 weeks implements .
Category
Lifestyle
2
Description
Control: The control group is without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz MS Institute
Full name of responsible person
Hashem Rahmati
Street address
MS institute Across the Dental School street Ghasroldasht shiraz fars
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars Province
City
shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mr. Hashem Rahmat
Position
Master of nursing
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.
City
Shiraz
Postal code
1978-71345
Phone
+98 71 3627 9135
Fax
Email
h_rahmati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hashem Rahmati
Position
MSc of Nursing
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Postal code
1978-71345
Phone
+98 71 3627 9135
Fax
Email
H-Ramati1076@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marziye Nooraei
Position
Master student of nursig
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3732 1016
Fax
Email
nooraei_m@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)