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The Evaluation of Effect of Telerehabilitation Education on Anxiety in People with Multiple Sclerosis

Protocol summary

Study aim
The purpose of the study is to investigate the effect of telerehabilitation education on the anxiety level of people who have recently been diagnosed with multiple sclerosis.
Design
The clinical trial has a control group, simple randomized, on 70 patients. Random Number Generator will be used for randomization.
Settings and conduct
The study will include telerehabilitation education in the form of education sessions (4 sessions) via Skype, on people visiting the Comprehensive Multiple Sclerosis Center located in Qaem Hospital in Mashhad. People can participate in the sessions at home or other places they prefer. Anxiety will be measured in both intervention and comparison groups before the intervention and 4 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Between 18-65 years, They have recently been diagnosed with MS, Expanded Disability Status Scale (EDSS) should be 4.0 or less, Able to read and write., have Sufficient knowledge in association with electronic devices and computers, Having a personal computer, laptop or smartphone, Have active internet access., Not participating in MS disease programs at the same time., Not suffering from other acute or chronic physical disorders. Exclusion criteria: Unwillingness to participate in the study.
Intervention groups
The intervention group will receive 4 sessions of telerehabilitation education. In the control group, they will receive their usual treatment before the study and will not receive any education.
Main outcome variables
Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230907059371N1
Registration date: 2023-09-18, 1402/06/27
Registration timing: prospective

Last update: 2023-09-18, 1402/06/27
Update count: 0
Registration date
2023-09-18, 1402/06/27
Registrant information
Name
Atieh Sadat Mariani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 2740
Email address
atieh.mariani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-21, 1402/06/30
Expected recruitment end date
2024-01-15, 1402/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of Effect of Telerehabilitation Education on Anxiety in People with Multiple Sclerosis
Public title
Telerehabilitation Education on Anxiety in People with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 Have recently been diagnosed with MS (maximum one year) and have been confirmed by a specialist. Expanded Disability Status Scale (EDSS) should be 4.0 or less and be approved by a specialist. Should be able to read and write. In case of not being able to read and write, the companion or caregivers of the person with MS should be able to read and write. Having sufficient knowledge In association with electronic devices and computers, or having a skilled person (caregiver of the patient or her/him first-degree relatives) to provide electronic devices Having a personal computer, laptop or smart phone Have active internet access Not participating in other MS education programs at the same time Not suffering from other acute or chronic physical disorders (debilitating heart, respiratory, liver, skeletal-muscular, renal, metabolic or other neurodegenerative diseases) recorded in the file. Not having severe hearing and cognitive disorders recorded in the file
Exclusion criteria:
Attending other education sessions. Severe auditory and cognitive disorders recorded in the file Suffering from other acute or chronic physical disorders (debilitating heart, respiratory, liver, skeletal-muscular, renal, metabolic or other neurodegenerative diseases) recorded in the file.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be assigned into two groups of comparison and intervention by randomization method using Random Number Generator software. In this way, people are coded in the order of entering the study(1,2,3...), then the numbers will be entered into the software in the same order(1-70). Then the sample volume will be entered to the data software. After that, random numbers will be generated by the software. The first 30 numbers will be in the intervention group and the second 30 numbers will be in the comparison 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 Iran University of Medical Science
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.IUMS.REC.1400.127

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
Anxiety
Timepoint
Measuring the level of anxiety at the beginning of the study (before the intervention) and 4 weeks after the end of the intervention
Method of measurement
Beck Anxiety questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Education will be provided by the researcher in 4 sessions, one session per week for 30 to 45 minutes in groups of 4 to 6 people through Skype software.The first session will be an introduction of people, discussion about multiple sclerosis and anxiety and sharing experiences about disease problems. The second session is titled: management of bladder and bowel problems. the third: Fatigue and pain management, and the fourth session will be: communication, physical activity in free time.
Category
Rehabilitation

2

Description
Control group: Does not receive any education
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive MS Center affiliated with Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mehran Beyraghi Tusi
Street address
AhmadAbad Blv, Parastar Ave, Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Reza Falak
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Atieh Sadat Mariani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
khayam shomali blv. - khayam 46- ali shokri blv.- shokri 8- amir 26- NO4
City
Mashhad
Province
Razavi Khorasan
Postal code
9196851564
Phone
+98 51 3768 2740
Email
Atieh.mariani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Atieh Sadat Mariani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
khayam shomali blv. - khayam 46- ali shokri blv.- shokri 8- amir 26- NO4
City
Mashhad
Province
Razavi Khorasan
Postal code
9196851564
Phone
+98 51 3768 2740
Email
Atieh.mariani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Atieh Sadat Mariani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
khayam shomali blv. - khayam 46- ali shokri blv.- shokri 8- amir 26- NO4
City
Mashhad
Province
Razavi Khorasan
Postal code
9196851564
Phone
+98 51 3768 2740
Email
Atieh.mariani@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
After de-identifying individuals, demographic and main outcome information will be shared.
When the data will become available and for how long
Access starts two months after the results are published
To whom data/document is available
The data will be accessible to researchers, students, clinicians, professors and patients.
Under which criteria data/document could be used
It will be available to use the data for further studies and increase the level of audience information
From where data/document is obtainable
In order to receive the data, audience can access the data by visiting the Central Library of Iran University of Medical Sciences at the address: Tehran, Hemat Highway, next to Milad Tower, Iran University of Medical Sciences, Central Library. Also, contact the researcher via email: atieh.mariani@gmail.com, contact number: 09383150595 and receive information.
What processes are involved for a request to access data/document
The applicant must visit the Central Library of Iran University of Medical Sciences in person and then request access to theses and search for the title of this thesis to access the contents. He/She can also access the information by sending a message through a contact number or email and introducing yourself and the purpose of requesting access to the data in less than 6 hours.
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