Determining the effectiveness of educational intervention through pictograms on fatigue and sleep quality in patients with multiple sclerosis
Design
This is a quasi-experimental study, with a sample size of 40 people in each group, based on the formula and findings of a similar study, with a 10% dropout rate. Convenience sampling will be used and the subjects will be assigned to two experimental and control groups using the card method.
Settings and conduct
MS Association of Shahrekord, intervention continues for 2 months
Blinding of participants and statistical analyst
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Confirmation of the disease by a neurologist
2-Age range between 20 and 50 years
3-No history of underlying diseases such as orthopedic, cardiovascular diseases, epilepsy, anemia
4- No history of mental disorder such as uncontrolled depression according to the diagnosis and confirmation of the doctor
5-No history of drug addiction and smoking
6-EDSS score between zero and 5
7-Awareness of the type of disease and willingness to participate in the study
8-Ability to read and write in Persian
Exclusion criteria:
1-Unwillingness to continue participating in the study
2-The extent of the individual's disability, confirmed by the attending physician and determined by the EDSS score, indicates that the patient is unable to continue participating in the study.
3- Occurrence of an acute attack of the disease during the study
Intervention groups
For the experimental group, educational intervention-educational pictograms will be used, for the control group, only routine care will be provided and the researcher will not have a role in implementing this care.
Main outcome variables
The outcome variables are fatigue severity and sleep quality.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240630062284N1
Registration date:2025-06-06, 1404/03/16
Registration timing:prospective
Last update:2025-06-06, 1404/03/16
Update count:0
Registration date
2025-06-06, 1404/03/16
Registrant information
Name
Komeil Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 4013
Email address
komeilzamani20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-23, 1404/05/01
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of educational intervention through pictograms on fatigue and sleep quality of patients with Multiple Sclerosis
Public title
Investigating the effectiveness of educational intervention through pictograms on fatigue and sleep quality of patients with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of the disease by a neurologist
Age range between 20 and 50 years
No history of underlying diseases such as orthopedic, cardiovascular diseases, epilepsy, anemia
No history of mental disorder such as uncontrolled depression as diagnosed and confirmed by a doctor
No history of drug addiction and smoking
EDSS score between zero and 5
Awareness of the type of disease and willingness to participate in the study
Ability to read and write in Persian
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria will be enrolled into the study using convenience sampling and will be divided into two equal intervention and control groups using block randomization with equal block sizes. Sealed envelopes will be used to ensure allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are aware of the purpose of the study but not the type of educational intervention. The data analyst will not have a role in data collection and statistical analysis will be performed in a blinded manner.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord, Kashani Blvd., University Headquarters
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.SKUMS.REC.1402.036
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Score obtained from completing the Pittsburgh Sleep Questionnaire
Timepoint
Two months after the start of the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
2
Description
Score obtained from the FSS fatigue scale
Timepoint
Two months after the start of the intervention
Method of measurement
fatigue severity scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Two months of use of pictogram content (including key points about the nature of the disease and medications, activity and diet before bedtime, stress management, principles of a balanced rest and activity schedule, and energy conservation)
Category
Treatment - Other
2
Description
Control group: For the control group, only routine care will be provided, and the researcher will have no role in implementing this care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Chaharmahal and Bakhtiari Province MS Patients Support Association (Shahrekord County)
Full name of responsible person
dr. asghar bayati
Street address
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3225 4700
Email
shdavodvand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
shirmohammad davoodvand
Street address
10th vally, Sadi street, Shahrekord,,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88158886464
Phone
+98 38 3333 6276
Email
shdavodvand@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Shirmohammad Davoodvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 9509
Email
shdavodvand@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shirmohammad Davoodvand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 9509
Email
shdavodvand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shirmohammad Davoodvand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 9509
Email
shdavodvand@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Biographical data such as age and gender are essential for better presentation of research results, and since this data is anonymous, there is no reason not to publish it.
When the data will become available and for how long
Due to the anonymity and coding of the data, they will be available after the study is completed.
To whom data/document is available
This data will be accessible to various health professionals and researchers.
Under which criteria data/document could be used
No analysis of this data is permitted and it will only be used for comparison with and citation of results from other studies.
From where data/document is obtainable
The download of the resulting article will be done according to the policy of the journal that publishes it. Therefore, the use of biographical data tables and other sections of the journal is possible after downloading. The email address of the responsible author included in the article will be available for communication with other authors and for guidance.
What processes are involved for a request to access data/document
For this purpose, the applicant can contact the office of the journal that published the article, the corresponding author, and the Vice President for Research of Shahrekord University of Medical Sciences. The duration of access depends on the policy of the journal and the Vice President for Research of the university, but the corresponding author will respond to the request of colleagues within a week.