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The effect of expressive writing on sexual dysfunction, quality of life and body image of women with multiple sclerosis

Protocol summary

Study aim
To determine the effect of expressive writing on levels of sexual dysfunction, quality of life and body image in women with multiple sclerosis
Design
Phase2 Randomized Trial Based on Random Number Table with Control Group The design of this study was based on 4groups of Solomon, with 2main intervention and control groups(52each), each one divided into 2groups (26each).Primary Intervention and Control Groups: no Completion of pre-test questionnaire (to reduce the effect of pre-test questionnaires on their attitudes),secondary Intervention and control groups: Completion of the pre and post test questionnaires
Settings and conduct
Sampling is in The referral specialized clinic for neurological diseases in Tehran.According to the random numbers table, the individuals in the intervention group receive individual training and in the control group, after explaining the goals, they are told that they will receive training after completing the first group course
Participants/Inclusion and exclusion criteria
Minimum literacy, Obtain a EDSS disability score of less than 4.5, At least one year after diagnosis, No use of drugs affecting sexual desire and sexual function in couples, No chronic other disease, Having sex at least once a month during the past month, No pregnancy or lactation, No traumatic event occurring three months prior to intervention according to patient, Access and ability to use virtual networks such as WhatsApp, Lack of communication between participants and other clients in that center,
Intervention groups
Intervention:Individuals in the intervention group at home start writing 3pages of morning assignments for 6weeks and write whatever comes to their mind. Control:They continue their treatment routinely and are visited by a physician every 3 months.this method will explain to control subjects at the end of study
Main outcome variables
Sexual dysfunction;Quality of Life;Body image

General information

Reason for update
Acronym
MS
IRCT registration information
IRCT registration number: IRCT20110629006917N4
Registration date: 2019-12-27, 1398/10/06
Registration timing: registered_while_recruiting

Last update: 2019-12-27, 1398/10/06
Update count: 0
Registration date
2019-12-27, 1398/10/06
Registrant information
Name
Leila Amini
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 3316 6574
Email address
l-amini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of expressive writing on sexual dysfunction, quality of life and body image of women with multiple sclerosis
Public title
The effect of expressive writing on sexual dysfunction, quality of life and body image of women with MS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum literacy Obtain an EDSS disability score of less than 4.5 to the physician's diagnosis At least one year after diagnosis Having sex at least once a month during the past month Access to and ability to use virtual networks such as WhatsApp Women with Multiple Sclerosis
Exclusion criteria:
Taking drugs that affect sexual function use of psychotropic drugs, alcohol, opiates, hallucinogens or drugs affecting sexual desire and sexual function in couples, as reported by the patient or registered in the case Chronic disease other than MS in research units pregnancy or lactation traumatic event occurring three months prior to intervention according to patient Relationship between participants with other clients in that center or non-membership of a virtual shared group
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
the allocation of samples in 4 groups A1 and B1 groups without pre-test, and groups A2 and B2 groups with pre-test and post-test will determine by computer random number table. And sampling will continue until completion of sample size in each The subgroups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
This study was designed as a four-group Solomon study to minimize the impact of pre-test questionnaires on attitude and subjectivity of research units. In this way we will have two intervention and two control groups and one intervention and one control group will complete pre-test and post-test questionnaires and the other two groups will answer only post-test questionnaires (Delavar, 2016). the explanation of the four groups is as follows.Control group A1: Includes those in the control group without pre-test, who will only complete the post-test questionnaires.Control group A2: Including control group who will complete the questionnaires in two stages before and after the intervention.Intervention group B1: Includes those in the intervention group without pre-test who will only complete the post-test questionnaires.Intervention group B2: Includes those in the intervention group who will complete the questionnaires in two stages before and after the intervention.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
iran national committee for Ethics in Biomedical Research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.IUMS.REC.1398.763

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis (MS)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Sexual dysfunction
Timepoint
Before intervention and immediately after intervention, four weeks and eight weeks after intervention
Method of measurement
The Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19)

2

Description
Quality of Life
Timepoint
Before intervention and immediately after intervention, four weeks and eight weeks after intervention
Method of measurement
Multiple Sclerosis Quality of Life-54 (MSQOL-54)

3

Description
Body image
Timepoint
Before intervention and immediately after intervention, four weeks and eight weeks after intervention
Method of measurement
Fisher Body Image Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group consists of 52 married women aged 18-45 years with multiple sclerosis who will be divided into two subgroups of 26 based on Solomon's design. The first group is the intervention group without pre-test and only completes the questionnaires after the intervention. The second group will complete the questionnaires in both stages before and after the intervention. The overall six-week intervention period is designed, with participants completing assignments each week. A commitment and service contract will be provided to the participants of the intervention groups and signed prior to starting writing at home to consider performing the work as part of their duties. Finally, the research units execute the program at home on a daily basis for 6 consecutive weeks. At the core of this method of writing are two central tools of writing: morning pages and an in-person artist appointment. Morning pages are such that they will write their morning pages every morning during these 6 weeks of intervention. Generally speaking, the morning pages consist of 3 regular handwritten pages, They write freely and without thinking and do not give up on paper. There is no wrong way to write the morning pages. Even if nothing comes to mind, the three pages say "nothing comes to mind." The definition of an in-house artist meeting is that they cultivate awareness every week for a full time (eg two hours). This appointment can be the best of the kind of tour, recreation and play they can plan in advance, and will not be canceled against any interference with or obstructions. At this meeting, no one is going to bring anyone, and we will tell them that this is a chance to listen to what you are saying. They will be told that there are probably many reasons to avoid doing this and the most common is to say that I am not in good financial shape, but the artist within you is a child who spends more time with her parents than It is money only and they can only go to shops and this principle is essential for self-care. For the sake of convenience, participants will be given five thousand dollars a week to donate to an artist within themselves. There are also a number of creative assignments each week that will be performed on different days until the end of each week. At the end of each week, an assessment will be made of how the assignments will be completed by completing the checklist
Category
Rehabilitation

2

Description
Control group: This group consists of 52 married women aged 18-45 years with multiple sclerosis who will be divided into two subgroups of 26 based on Solomon's design. The first group is the intervention group without pre-test and only completes the questionnaires after the intervention. The second group will complete the questionnaires in both stages before and after the intervention. The control group is routinely monitored. After completion of the intervention group, a Justification meeting will be held for both control groups and a weekly service plan will be presented.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized Clinic for Neurological Diseases and Multiple Sclerosis
Full name of responsible person
Dr. Seyed Massoud Nabavi
Street address
Mulla Sadra, Between Sheikh Baha'i and Chamran, No. 218, Arya Medical Complex, Fourth Floor, Unit 13
City
tehran
Province
Tehran
Postal code
1435915466
Phone
+98 21 8862 2939
Email
massoodnabavi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Leila Amini
Street address
Iran University of Medical Sciences, Hemmat Highway, Next to Milad Tower
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Leila Amini
Position
Assistant Professor of Reproductive Health School of Nursing and Midwifery Iran University of Medica
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tehran, Valiasr Ave., above Vanak Square, Rashid Yasimi Street
City
tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
amini.l@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amini
Position
Assistant Professor of Reproductive Health School of Nursing and Midwifery Iran University of Medica
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tehran, Valiasr Ave., above Vanak Square, Rashid Yasimi Street
City
tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
amini.l@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amini
Position
Assistant Professor of Reproductive Health School of Nursing and Midwifery Iran University of Medica
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tehran, Valiasr Ave., above Vanak Square, Rashid Yasimi Street
City
tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
amini.l@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"No more information".
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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