Determining the effect of educational intervention of self-care behaviors on the quality of life and resilience of multiple sclerosis (MS) patients.
Design
A total of 135 patients who meet the criteria for entering the study without blinding will be randomly assigned to intervention and control groups. Random allocation will be done using the random sequence generation method using the table of random numbers in the Excel software
Settings and conduct
With the aim of determining the effect of the educational intervention of self-care behaviors on the quality of life and resilience of multiple sclerosis patients in Shiraz, 135 patients were selected as available sampling. Then, these patients were randomly selected into two intervention groups (experiment) and control group through Randoxel. After that, they will be checked by completing the pre-intervention questionnaires, and in the future, the test group will be trained under the intervention training designed based on the Orem model. After two months, the questionnaires will be completed again and the effect of the intervention will be calculated.
Participants/Inclusion and exclusion criteria
1-Having symptoms of the disease- Do not use a wheelchair unless you are in the acute stage of the disease3- Have a disease for at least 2 to 5 years4- Patients did not participate in self-care training5- Ability to read and write6- The age of the patients should be between 15 and 50 years
Intervention groups
1- The group receiving self-care training (intervention group)2- control group
Main outcome variables
Quality of life and resilience of multiple sclerosis (MS) patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221106056414N1
Registration date:2023-01-26, 1401/11/06
Registration timing:prospective
Last update:2023-01-26, 1401/11/06
Update count:0
Registration date
2023-01-26, 1401/11/06
Registrant information
Name
shohreh afroozeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3353 6316
Email address
mgaziri3000@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention of self-care behaviors on the quality of life and resilience of multiple sclerosis (MS) patients.
Public title
The effect of educational intervention of self-care behaviors on the quality of life and resilience of multiple sclerosis (MS) patients.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1-Having symptoms of the disease2- Do not use a wheelchair unless you are in the acute stage of the disease3- Have a disease for at least 2 to 5 years4- Patients did not participate in self-care training5- Ability to read and write6- The age of the patients should be between 15 and 50 years
Exclusion criteria:
The patient is suffering from multiple sclerosis (MS) and has no underlying 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:
135
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 135 patients who meet the criteria for entering the study without blinding will be randomly assigned to intervention and control groups. Random allocation will be done using the random sequence generation method using the table of random numbers in the Excel software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشگاه علوم پزشکی شیراز
Street address
Zand Ave-Shiraz university of medical sciences-Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1400.098
Health conditions studied
1
Description of health condition studied
Multiple sclerosis (MS) patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determining the effect of educational intervention on the care of multiple sclerosis (MS) patients
Timepoint
Two months after training
Method of measurement
Standard questionnaire of patients' self-care status
Secondary outcomes
1
Description
Determining the effect of self-care training intervention on the resilience of multiple sclerosis (MS) patients
Timepoint
Two months after training
Method of measurement
Resilience questionnaire
2
Description
Determining the effect of self-care training intervention on improving the quality of life of multiple sclerosis (MS) patients
Timepoint
Two months after training
Method of measurement
Quality of life guidelines for MS patients (MSIS-29)
Intervention groups
1
Description
The group receiving training on self-care behaviors who have received the training intervention course. The training course is designed for 6 sessions of 60 minutes each session will be taught theoretically and practically. Self-care programs are for controlling symptoms such as physical movement disorders, muscle weakness, muscle cramps, fatigue, imbalance while walking, urinary and defecation disorders, and memory and vision problems.
Category
Lifestyle
2
Description
Control group: a group of patients who have received routine training. These patients are thanked in the initial briefing session and are trained by themselves only through pamphlets and booklets.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz MS Association
Full name of responsible person
Hamed Hossaini
Street address
Qasroldasht Ave-Shiraz MS Association-Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7186783435
Phone
+98 71 3627 5779
Email
MS -SHIRAZ@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahid Hossaini
Street address
Zand Ave-Shiraz university of medical sciences-Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 2559
Email
President_d@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shohre Afroozeh
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Zand Ave-Shiraz university of medical sciences-Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 2559
Email
SHAFROOZEH99@GMAIL.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shohre Afroozeh
Position
UNIVERCITY STUDENT
Latest degree
Bachelor
Other areas of specialty/work
Environmental Health
Street address
Zand Ave-Shiraz university of medical sciences-Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
071323559
Email
SHAFROOZEH99@GMAIL.COM
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shohre Afroozeh
Position
UNIVERCITY STUDENT
Latest degree
Bachelor
Other areas of specialty/work
Environmental Health
Street address
Zand Ave-Shiraz university of medical sciences-Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
071323559
Email
SHAFROOZEH99@GMAIL.COM
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available