Investigating the effect of peer-based education based on Pender health promotion model on quality of life, stress management and Self-efficacy in patients with multiple sclerosis
Determining the effect of peer-based education based on Pender health promotion model on quality of life, stress management and self-efficacy in patients with multiple sclerosis
Design
This study is a randomized clinical trial without blinding. The study population was patients with multiple sclerosis (MS). The sample size based on previous studies with 95% confidence level and 90% test power of 80 people (40 people in each group) will be considered. Random allocation sampling method It is simple to put 80 cards in an envelope written on 40 letters A and 40 cards B, then patients who meet the inclusion criteria are asked to take a card if If they take card A, they will be in the intervention group, and if they take card B, they will be in the control group, and this process will continue until the sample size is completed.
Settings and conduct
he study site of MS clinic is in Fasa city in the south of Fars province. This study is a double-blind randomized clinical trial. Blinding will be done in researcher and patient mode.
Participants/Inclusion and exclusion criteria
This study is a randomized clinical trial without blinding .The study population was patients with multiple sclerosis (MS). The sample size based on previous studies with 95% confidence level and 90% test power of 80 people (40 people in each group) will be considered.
Intervention groups
The educational intervention consists of five 1-minute training sessions once a week for the intervention group by a peer. Question and answer sessions will also be conducted by a peer and researcher during the week. The control group will receive routine training by the MS Clinic. They will also be provided with a training booklet.
Main outcome variables
Quality of life, stress management, self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044802N3
Registration date:2022-02-06, 1400/11/17
Registration timing:registered_while_recruiting
Last update:2022-02-06, 1400/11/17
Update count:0
Registration date
2022-02-06, 1400/11/17
Registrant information
Name
Mostafa Bijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 5012
Email address
bizhani_mostafa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of peer-based education based on Pender health promotion model on quality of life, stress management and Self-efficacy in patients with multiple sclerosis
Public title
Investigating the effect of peer-based education based on Pender health promotion model on quality of life, stress management and Self-efficacy in patients with multiple sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have a minimum literacy
Age between 18 and 50 years
No speech or hearing impairment
Exclusion criteria:
Suffering from severe mental and emotional disorders
Acute disease
Age
From 18 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
The sampling method is simple random assignment in which we put 80 cards in an envelope written on 40 letters A and 40 cards B, then patients who meet the inclusion criteria are asked to If they take a card, if they take an A card, they will be in the intervention group, and if they take a B card, they will be in the control group, and this process will continue until the sample size is completed.
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 Fasa University of Medical Sciences
Street address
Ibn Sina Square - Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2021-03-16, 1399/12/26
Ethics committee reference number
IR.FUMS.REC.1399.197
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis (MS)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Quality of Life
Timepoint
Before, immediately and three months later
Method of measurement
Quality of life questionnaire in MS patients
2
Description
Self-efficacy
Timepoint
Before, immediately and three months later
Method of measurement
General Self-Efficacy Questionnaire (GSES) Scherer et al
3
Description
stress management
Timepoint
Before, immediately and three months later
Method of measurement
Stress Management Questionnaire (Cobain et al.)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: The educational intervention consists of five 1-minute training sessions once a week for the intervention group by a peer. Question and answer sessions will also be conducted by a peer and researcher during the week
Category
Lifestyle
2
Description
Control group: will receive routine training by MS Clinic. They will also be provided with a training booklet. .
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital Fasa
Full name of responsible person
Mostafa Bijani
Street address
Shariati Street . Shariati Hospital
City
Fasa
Province
Fars
Postal code
7461686688
Phone
Fax
Email
bizhani_mostafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Farjam
Street address
Sinai Square. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
Email
farjam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Assistant Professor. Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Square. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7464686688
Phone
0071 9173308451
Email
bizhani_mostafa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Assistant Professor. Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Square. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
071 9173308451
Email
bizhani_mostafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Assistant Professor. Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Square. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
071 9173308451
Email
bizhani_mostafa@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
To use the educational content and analyze the data, send an email to the executor of the project
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Request permission from the developer to receive information and use the data
From where data/document is obtainable
Send an email to the project executor at the following address
bizhani _mostafa@yahoo.com
What processes are involved for a request to access data/document
Send an email to the project executor at the following address
bizhani _mostafa@yahoo.com