Investigating the effects of self-care education through podcast on self-esteem and worry of patients with multiple sclerosis: A parallel randomized clinical trial
Determining the effect of self-care education in the form of a podcast on the self-esteem and anxiety of patients with multiple sclerosis will be done.
Design
A parallel randomized clinical trial including 72 patients, double blinded
Settings and conduct
The self-care training program will be held once a week for 6 weeks. The method of the self-care training program will be available to the participants of the test group under pre-produced podcasts. Immediately and two months after the end of the intervention for the test group, both groups will complete the self-esteem questionnaire and the anxiety questionnaire again.
Participants/Inclusion and exclusion criteria
Entry criteria: - Membership in Multiple Sclerosis Association of Iran
- Age between 18 and 50 years- Having a smartphone with the ability to install WhatsApp software- At least one year has passed since the diagnosis of MS
- Being literate in reading and writing.
Exit criteria :- Suffering from severe physical limitations caused by the disease (advanced stages of the disease)- Suffering from severe mental disorders- Experience of participating in educational programs related to self-care
Intervention groups
In the test group, the participants will be subjected to the intervention of the self-care program. 6 audio files will be prepared and will be held once a week for 6 weeks. The participants of the control group will receive the same treatments and routine care that they received before participating in the study, and at the end of the study, the intervention of the self-care program will also be shared for the control group .Immediately and two months after the completion of the intervention for the test group, both groups will complete the self-esteem questionnaire and the anxiety questionnaire again.
Main outcome variables
Self-esteem and worry of patients with multiple sclerosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250907067152N1
Registration date:2025-10-01, 1404/07/09
Registration timing:prospective
Last update:2025-10-01, 1404/07/09
Update count:0
Registration date
2025-10-01, 1404/07/09
Registrant information
Name
fateme babazade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 1850
Email address
fatemeh.babazade1379@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2027-10-23, 1406/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of self-care education through podcast on self-esteem and worry of patients with multiple sclerosis: A parallel randomized clinical trial
Public title
Investigating the effects of self-care education through podcast on self-esteem and worry of patients with multiple sclerosis: A parallel randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Membership in Iran's Multiple Sclerosis Association
Age between 18 and 50 years
Having a smartphone with the ability to install WhatsApp software
At least one year has passed since the diagnosis of MS-
Being literate in reading and writing.
Exclusion criteria:
Having severe physical limitations caused by the disease (advanced stages of the disease)
Suffering from severe mental disorders
Experience of participating in educational programs related to self-care
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:
72
Randomization (investigator's opinion)
Randomized
Randomization description
In the current study, patients will be selected based on the criteria desired by the researcher and by the available sampling method, and based on the software, the patients will be grouped into blocks of four and will be placed in two groups, test and control. The order of randomization will be done secretly.It means that there are 72 envelopes in the package, each of which contains a code. After it is determined that the target person participates in the study, the researcher takes the target envelope in the specified order and acts according to the group registered in the envelope.
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 Shahrood University of Medical Sciences
Street address
Haft Tir Square
City
shahrood
Province
Semnan
Postal code
3614773943
Approval date
2025-09-13, 1404/06/22
Ethics committee reference number
IR.SHMU.REC.1404.067
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
Self-esteem before selfcare training
Timepoint
Before the start of the intervention and immediately and two months after the end of the intervention
Method of measurement
Rosenberg self-esteem questionnaire
2
Description
Anxiety before self-care training
Timepoint
Before the start of the intervention and immediately and two months after the end of the intervention
Method of measurement
Pennsylvania Anxiety Inventory
Secondary outcomes
1
Description
Self-esteem after self-care training
Timepoint
Before the start of the intervention and immediately and two months after the end of the intervention
Method of measurement
Rosenberg self-esteem questionnaire
2
Description
Anxiety after self-care training
Timepoint
Before the start of the intervention and immediately and two months after the end of the intervention
Method of measurement
Pennsylvania Anxiety Inventory
Intervention groups
1
Description
Intervention group: 6 audio files, each of which is an episode, and the duration of each episode is 10 to 20 minutes, are prepared, and the self-care training program is held once a week for 6 weeks. The method of the self-care training program will be provided to the participants of the test group under pre-produced podcasts
Category
Treatment - Other
2
Description
Control group: Control participants will receive all the treatments and routine care they received before participating in the study, and at the end of the study, a self-care training program will be shared for the control group. Immediately and two months after the end of the intervention for the test group, both groups will complete the self-esteem questionnaire and the anxiety questionnaire again.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
D.Hossein Bagheri
Street address
Taghi Abad square
City
mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3845 3239
Email
bagheri@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Ebrahimi
Street address
Haft Tir Square, Shahrood University of Medical Sciences
City
shahrood
Province
Semnan
Postal code
361473947
Phone
+98 23 3239 5054
Email
vcr@shmu.a.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
D.Hossein Bagheri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrood University of Medical Sciences, Haft Tir Square
City
Shahrood
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
D.Hossein Bagheri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrood University of Medical Sciences, Haft Tir Square
City
Shahrood
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
D.Hossein Bagheri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrood University of Medical Sciences, Haft Tir Square
City
Shahrood
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
bagheri@shmu.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