general purpose: Determining the effect of self-care training with telenursing method on fatigue and stress of multiple sclerosis patients in Zahedan City in 2023
Specific goals:
1- Determining and comparing the average fatigue score of multiple sclerosis patients in two control and intervention groups before and after the intervention
2- Determining and comparing the average stress score of multiple sclerosis patients in two control and intervention groups before and after the intervention
Design
Clinical trial with control group, with parallel groups, randomized, on 80 patients.
Settings and conduct
The researcher will collect data by referring to the Zahedan MS Association. information about individual characteristics, severity of fatigue; And stress will be completed by the researcher through the interview method. Became. After 8 weeks (the end of the intervention), the questionnaires are completed again.
Participants/Inclusion and exclusion criteria
Entry requirements:
- Being literate in reading and writing
- File in MS forum
-Access to mobile phone and internet
- At least 1year history of the disease
- Obtaining a score of 4 or less than 4 on the EDSS scale of extensive disability status
- Do not be part of the treatment team
Non-entry conditions:
- The person's lack of consent to continue the research
Intervention groups
In the intervention group, the fatigue and stress self-care training program will be communicated to patients in the form of podcasts and videos through the site. Every week for 6 weeks, training will be uploaded on the site on Saturdays.
In the control group, the patients receive routine training provided by the MS Association.
Main outcome variables
In this study, the results of fatigue and stress in two intervention and control groups were evaluated before and after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231230060571N1
Registration date:2024-03-04, 1402/12/14
Registration timing:retrospective
Last update:2024-03-04, 1402/12/14
Update count:0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
shaghayegh Roshanghiyas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 9595
Email address
roshanshaghayegh78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of self-care training with telenursing method on fatigue and stress of multiple sclerosis patients
Public title
the effect of self-care training with telenursing method on fatigue and stress of multiple sclerosis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being literate in reading and writing
Having a file in the MS forum
Mobile phone and internet access
At least 1 year history of the disease
Obtaining an EDSS score of 4 or less than 4 on the extensive disability status scale (adequate ability for self-care)
Do not be part of the treatment team
Exclusion criteria:
The person's lack of consent to continue the research
The occurrence of a severe stressful event during the research
Age
No age limit
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
The research units will be selected in an accessible way and will be assigned to two control and intervention groups using a simple random allocation method. In this way, the first sample will be placed in the intervention or control group by lottery, and after that, the research units will be placed in groups in the middle.
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
Ethics committee of Zahedan university of Medical Sciences
Street address
Zibashahr neighborhood, Alborz St., Kosar East St., P.878
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817945669
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.ZAUMS.REC.1402.069
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35-G37
ICD-10 code description
Diseases of the nervous system
Primary outcomes
1
Description
Fatigue score in the Fatigue Severity Questionnaire (FSS)
Timepoint
At the beginning of the study and 56 days after the beginning of the study
Method of measurement
Fatigue Severity Questionnaire (FSS)
2
Description
Stress score in the perceived stress questionnaire of Cohen et al
Timepoint
At the beginning of the study and 56 days after the beginning of the study
Method of measurement
perceived stress questionnaire of Cohen et al
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The fatigue and stress self-care training program will be informed to the patients in the form of podcasts and videos through the site, and the patients will be taught about the website address and how to use it. Every week for 6 weeks, one training will be given on the site on Saturdays. It will be loaded. patients will be able to ask the researcher their questions by leaving a text or voice message at any time, and the researcher will answer them in the form of a podcast or text message.
Category
Other
2
Description
Control group: Patients receive routine education provided by the MS Society.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan MS Association
Full name of responsible person
Ghulam Abdi
Street address
Azadegan Blvd., after Shahid Mazari intersection, next to Sadaf Real Estate Company
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
ندارد
Phone
+98 54 3343 8108
Fax
Email
a3920365@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Abraham Kord
Street address
Zahedan - Doctor Hasabi Square - Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
-
Phone
+98 54 3337 2151
Email
info@zaums.ac.ir
Web page address
https://zaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
60
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
Zahedan University of Medical Sciences
Full name of responsible person
Shaghayegh Roshanghiyas
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Zibashahr neighborhood, Alborz St., Kosar East St., not reached Besharat, P.878
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817945669
Phone
333289595
Email
roshanshaghayegh78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shaghayegh Roshanghiyas
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Zibashahr neighborhood, Alborz St., Kosar East St., not reached Besharat, P.878
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817945669
Phone
33289595
Email
roshanshaghayegh78@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shaghayegh Roshanghiyas
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Zibashahr neighborhood, Alborz St., Kosar East St., not reached Besharat, P.878
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817945669
Phone
+98 54 3328 9595
Email
roshanshaghayeg76@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