The effect of self-management program based on virtual group discussion on fatigue, sleep quality and quality of life in patients with multiple sclerosis
Determining the effect of self-management program based on group discussion by virtual method, on fatigue, sleep quality and quality of life in patients with multiple sclerosis referred to MS Urmia Association in 1400
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, on 60 patients. Randomizer software was used for randomization.
Settings and conduct
Among the patients referred to Urmia MS Association, based on the inclusion criteria, 60 samples were selected by easy sampling method and randomly assigned to a control group and an intervention group using Randomizer web-based software. One-way blinding and the intervention and control groups are not aware of the type of intervention. Sealed consecutive matte envelopes were used to conceal the allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
With multiple sclerosis
Age between 50-20 years
Having a smartphone
No physical or mental illness
Being literate
Communicate verbally
Do not participate in any self-care training courses.
Exclusion criteria:
Do not attend more than one session
Reluctance to participate in the study.
Intervention groups
Patients in the intervention group will receive the educational content of the self-care program through discussion with other members of the group in WhatsApp during 6 one-hour sessions every 5 days for one month. No educational intervention will be performed on patients in the control group.
Main outcome variables
quality of life, sleep and fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211218053443N1
Registration date:2022-02-01, 1400/11/12
Registration timing:registered_while_recruiting
Last update:2022-02-01, 1400/11/12
Update count:0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
zahra valinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3386 0087
Email address
zahra.valinasab20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management program based on virtual group discussion on fatigue, sleep quality and quality of life in patients with multiple sclerosis
Public title
The effect of self-management program based on virtual group discussion on fatigue, sleep quality and quality of life in patients with multiple sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. Having MS with the approval of a neurologist
2. Having an age between 20-50 years
3. Having a smartphone and being able to work with it
4. No other physical and mental illness
5. Having reading and writing literacy
6. Verbal communication with the researcher
7. Having at least three years of history of MS (almost according to studies after three years the symptoms of fatigue begin)
8. Not attending any self-care training course
Exclusion criteria:
Not attending more than one session and unwillingness to participate in the study
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple and individual way using Randomizer random allocation software. Individuals are listed according to the national code and then divided into groups 1 (intervention) and group 2 (control) using random allocation software.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the researcher knows which patient is in the control group and which patient is in the intervention group. Without the patient being aware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
No. 41, Alley 3,Razi Street,Andisheh Town,Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5716138776
Approval date
2021-05-28, 1400/03/07
Ethics committee reference number
IR.UMSU.REC.1400.402
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
fatigue
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Fatigue Impact Scale
2
Description
Sleep Quality
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Pittsburgh Sleep Quality Index
3
Description
Quality of life
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Multiple Sclerosis Quality of Life Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group receive the educational content of their self-care program by discussing with other members of the group in WhatsApp during 6 one-hour sessions, once every 5 days for a month.
Category
Treatment - Other
2
Description
Control group: In this group are MS patients who are not treated.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia MS Patients Association
Full name of responsible person
Dr. Mulla Farajzadeh
Street address
Almas Gharb Building, next to Melli Bank, Danesh Street,
City
Urmia
Province
West Azarbaijan
Postal code
5716138776
Phone
+98 44 3225 7209
Fax
+98 44 3225 7209
Email
infoteam@mssociety.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Madine Jasemi
Street address
Faculty of Nursing and Midwifery, Nazlo Campus,11 km to Sarv Road
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3275 4961
Fax
+98 44 3275 4921
Email
nursing-college@umsu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
50
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
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Madine Jasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Nazlo Campus,11 km to Sarv Road
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3275 2741
Fax
+98 44 3275 4921
Email
Jasemi.m@umsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zahra.Valinasab
Position
Graduate student of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 41,3rd Alley,Razi Street,Andisheh Town
City
Urmia
Province
West Azarbaijan
Postal code
5716138776
Phone
+98 44 3386 0087
Fax
Email
zahra.valinasab20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zahra.Valinasab
Position
Graduate student of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 41,3rd Alley,Razi Street,Andisheh Town
City
Urmia
Province
West Azarbaijan
Postal code
5716138776
Phone
+98 44 3386 0087
Email
zahra.valinasab20@gmail.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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Article
When the data will become available and for how long
2021-2022
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
1- Reference in articles and dissertations 2- Having a code of ethics in your studies 3- Valid academic emails
From where data/document is obtainable
Zahra Vali Nasab, Urmia School of Nursing and Midwifery
Zahra.valinasab20@gmail.com
What processes are involved for a request to access data/document