Determining the effect of written expression on sexual self-concept of men with multiple sclerosis
Design
Randomized control clinical trial which will done on 70 men with MS. Participants assigned to two study groups by random number table which extracted from www.randomization.com site.
Settings and conduct
The intervention will be performed in a specialized clinic for neurological diseases and multiple sclerosis located in Tehran for 4 weeks and they will express their emotions and express their feelings in writing.
Participants/Inclusion and exclusion criteria
1. Having at least one sex in the last month
2. EDSS number lower than 5.5 approved by neurologist
3. Literate men
4. Access to virtual networks such as WhatsApp
5. Monogamy
6. At least one year from marital date
Intervention groups
The intervention is designed for 4 weeks virtually through WhatsApp along with weekly follow-up. Participants will express their emotions and feelings by writing at least once a week for 15 to 30 minutes. The control group will receive only routine care.
Main outcome variables
Sexual self-concept
General information
Reason for update
Acronym
MS
IRCT registration information
IRCT registration number:IRCT20211028052892N1
Registration date:2021-11-17, 1400/08/26
Registration timing:registered_while_recruiting
Last update:2021-11-17, 1400/08/26
Update count:0
Registration date
2021-11-17, 1400/08/26
Registrant information
Name
malihe Mohammadzadeh Sabbaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5520 3392
Email address
malihe.m.7776@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-02-18, 1400/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Expressive Writing On Sexual Self-Concept Of Men With Multiple Sclerosis
Public title
Expressive Writing and Sexual Self-Concept Of Men With M.S
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least one sex in the last month
EDSS number lower than 5.5 approved by neurologist
Be literate
Access to virtual networks such as WhatsApp
Monogamy
At least one year from marital date
Exclusion criteria:
Suffering from other chronic systemic or psychiatric diseases (such as heart, respiratory diseases, etc.)
Infertile Couples
Use of psychiatric drugs, alcohol and drug abusers or sexual function affected drugs
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to two intervention and control groups randomly. Randomization will be based on the table of random numbers extracted from www.randomization.com site.
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 Sciences
Street address
Valid Asr St., Rashid Yasemi St., Iran School of Nursing and Midwifery, Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2021-10-22, 1400/07/30
Ethics committee reference number
IR.IUMS.REC.1400.662
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
Sexual self-concept
Timepoint
Before, immediately and four weeks after the intervention
Method of measurement
The Multi-dimentional Sexual Self- Concept Questionnaire
2
Description
Sexual self-concept
Timepoint
Before, immediately and four weeks after the intervention
Method of measurement
The Multi-Dimentional Sexual Self- Concept Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention is designed for 4 weeks virtually through WhatsApp along with weekly follow-up. Participants will express their emotions and feelings by writing at least once a week for 15 to 30 minutes. Educational content will be taught to people via WhatsApp voice message. Also, explanations and how to implement the intervention will be provided to them in writing in the form of a message. During the intervention, communication with participants for weekly follow-up will be established only through telephone and virtual networks, including WhatsApp.
Category
N/A
2
Description
Control group: People in the control group will only receive routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
the specialized clinics for neurological diseases and multiple sclerosis
Full name of responsible person
Maliha Mohammadzadeh Sabbaghi
Street address
No. 218, Aria Doctors Complex, Fourth Floor, Unit 14,Mulla Sadra, Between Sheikh Baha'i and Chamran
City
Tehran
Province
Tehran
Postal code
8717764898
Phone
+98 21 4365 1000
Email
malihe.m.7776@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hossein Keyvani
Street address
Ghaem 8, Hosseinpour Alley, Basij Square
City
Kashan
Province
Isfehan
Postal code
8717764898
Phone
+98 31 5520 3392
Email
malihe.m.7776@gmail.com
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
Maliha Mohammadzadeh Sabbaghi
Position
دانشجو
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ghaem 8, Hosseinpour Alley, Basij Square
City
Kashan
Province
Isfehan
Postal code
8717764898
Phone
+98 31 5520 3392
Email
malihe.m.7776@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maliha Mohammadzadeh Sabbaghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ghaem 8, Hosseinpour Alley, Basij Square
City
Kashan
Province
Isfehan
Postal code
8717764898
Phone
+98 31 5520 3392
Email
malihe.m.7776@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maliha Mohammadzadeh Sabbaghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ghaem 8, Hosseinpour Alley, Basij Square
City
Kashan
Province
Isfehan
Postal code
8717764898
Phone
+98 31 5520 3392
Email
malihe.m.7776@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
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
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Access period starts 6 months after printing
To whom data/document is available
Study researchers and academics
Under which criteria data/document could be used
As long as the confidentiality of the data is not violated.
From where data/document is obtainable
Email address: malihe.m.7776@gmail.com
What processes are involved for a request to access data/document
After the request, the information will be provided to him through the mentioned email within a few days.