Effect of peer education and nurse education versus control group on the quality of life, resilience and anxiety of multiple sclerosis patients: a randomized clinical trial
To assess the effect of peer education and nurse education versus control group on the quality of life, resilience and anxiety of multiple sclerosis patients
Design
This is a randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the drawing of lots to the intervention and control groups
Settings and conduct
This study will be performed in the MS Association in Hamadan city on 120 eligible patients with multiple sclerosis. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 20 to 45 years
Suffering from multiple sclerosis
Having anxiety
Being literate
Exclusion criteria:
Speech or hearing impairment
Recurrence of the disease
Intervention groups
Intervention group 1:
Routine recommendations in addition to educational sessions for 45 to 60 minutes every two days for 5 sessions by a person with multiple sclerosis with at least 5 years of disease history
Intervention group 2:
Routine recommendations in addition to educational sessions for 45 to 60 minutes every two days for 5 sessions by a nurse
Control group:
Routine recommendations
Main outcome variables
Primary outcome:
Quality of life, resilience, anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N464
Registration date:2023-03-08, 1401/12/17
Registration timing:prospective
Last update:2023-03-08, 1401/12/17
Update count:0
Registration date
2023-03-08, 1401/12/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of peer education and nurse education versus control group on the quality of life, resilience and anxiety of multiple sclerosis patients: a randomized clinical trial
Public title
Effect of peer education and nurse education versus control group on the quality of life, resilience and anxiety of multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 45 years
Suffering from multiple sclerosis
Having anxiety
Being literate
Exclusion criteria:
Speech or hearing impairment
Recurrence of the disease
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare three sheets and write "intervention 1" and "intervention 2" and "control" on them. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-02-05, 1401/11/16
Ethics committee reference number
IR.UMSHA.REC.1401.979
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
Quality of life
Timepoint
Before the intervention and 2 months after
Method of measurement
Using the Multiple Sclerosis Quality of Life (MSQOL)
2
Description
Resilience
Timepoint
Before the intervention and 2 months later
Method of measurement
Using Connor & Davidson Resilience Scale
3
Description
Anxiety
Timepoint
Before the intervention and 2 months after
Method of measurement
Using the Spielberger Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Routine recommendations in addition to educational sessions for 45 to 60 minutes every two days for 5 sessions by a person with multiple sclerosis with at least 5 years of disease history (including causes of multiple sclerosis, common treatments, importance of adherence to treatment, importance of nutrition, stress control, hygiene, adequate sleep, exercise and activity, imbalance and its management, self-management of constipation, control of urinary incontinence, self-management of memory disorders)
Category
Treatment - Other
2
Description
Intervention group 2: Routine recommendations in addition to educational sessions for 45 to 60 minutes every two days for 5 sessions by a nurse (including causes of multiple sclerosis, common treatments, importance of adherence to treatment, importance of nutrition, stress control, hygiene, adequate sleep, exercise and activity, imbalance and its management, self-management of constipation, control of urinary incontinence, self-management of memory disorders)
Category
Treatment - Other
3
Description
Control group: Routine recommendations
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Association in Hamadan city
Full name of responsible person
Mohammad Mehdi Siahvashi
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mohammadmehdi2177mui@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Siahvashi
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
6517838695 00988138380572
Email
mohammadmehdi2177mui@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Azim Azizi
Position
PhD in Nursery
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
a.azizi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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