Protocol summary
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Study aim
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The effect of education of sexual health promotion package on sexual dysfunction and sexual quality of life in multiple sclerosis women
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Design
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This study is a randomized controlled clinical trial, and 72 women with multiple sclerosis will be randomly assigned into two intervention and control groups.
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Settings and conduct
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In this study, 72 married women with multiple sclerosis who referred to Iranian MS Society after obtaining informed consent will be randomly assigned into intervention and control groups. In the intervention group, sexual health education and counseling will be provided in 6 sessions, and no education or counseling will be provided to the control group
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Married women with multiple sclerosis, age of 18 to 50 years old; having sexual dysfunction (selecting “often” or “always” options in at least one question from the MSISQ-19)؛ having sexual activity during the last six months; EDSS <7؛ have no severe depression or severe fatigue.
Exclusion criteria: Other acute and chronic diseases; being at the stage of recurrence or disease attack and receiving other treatments for sexual dysfunction.
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Intervention groups
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Multiple sclerosis women in the intervention group will receive Face-to-Face sexual health education and counseling in six sessions -90 minutes during six weeks through lecture, Question-Answer method and role-play. The sexual health promotion package was designed after several stages of quantitative and qualitative research, experts panel, and then searching in the literature.
Women in the control group will not receive any intervention by the research team during the study.
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Main outcome variables
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Sexual dysfunction with Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19) and sexual quality of life with sexual quality of life-female (SQOL-F) questionnaire.
General information
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Reason for update
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The word of "sexual function" was changed to "sexual dysfunction". This change was made because of the MSISQ-19 measures "sexual dysfunction "and it was mentioned by mistake.. It should be noted that during the implementation process, no change was made in the study structure and only the word of "sexual function" was changed to "sexual dysfunction".
Also, in order to examine the effect of the intervention more closely, another follow-up was added 1 month after the intervention, and the follow-up times changed to immediately, 1 month, and 2 months after the intervention.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190721044292N1
Registration date:
2019-09-01, 1398/06/10
Registration timing:
prospective
Last update:
2020-04-27, 1399/02/08
Update count:
1
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Registration date
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2019-09-01, 1398/06/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-06, 1398/06/15
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Expected recruitment end date
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2020-01-05, 1398/10/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of education of sexual health promotion package on sexual dysfunction and sexual quality of life in multiple sclerosis women: designed from the results of a mixed-method study
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Public title
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The effect of sexual health education on sexual dysfunction and sexual quality of life in women with multiple sclerosis
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Iranian
Age of 18 to 50 years old
Being married
Confirmed diagnosis of MS by a neurologist based on McDonald's criteria
Have sexual activity during the last six months
In a stage of the disease, that is possible for her to perform routine activities including having a sexual relationship with her spouse (EDSS <7)
Not pregnant or breastfeeding
Selecting “often” or “always” options in at least one question from the MSISQ-19
Have no severe depression or severe fatigue (score less than 29 in the BDI-II and score less than 5/1 in the FSS)
Exclusion criteria:
Being at the stage of recurrence or disease attack
Have other acute and chronic disease
Receiving any kind of treatment for sexual dysfunction
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Age
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From 18 years old to 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done by using random numbers in Excel software (Rand () function).
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-02-26, 1396/12/07
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Ethics committee reference number
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IR.SBMU.PHNM.1396.1003
Health conditions studied
1
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Description of health condition studied
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Multiple Sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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Sexual dysfunction
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Timepoint
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Before the intervention, immediately after the intervention, one and two months after the intervention
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Method of measurement
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Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19)
2
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Description
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Sexual Quality of life
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Timepoint
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Before the intervention, immediately after the intervention , one and two months after the intervention
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Method of measurement
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sexual quality of life-female (SQOL-F) questionnaire
Intervention groups
1
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Description
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Women with multiple sclerosis in the intervention group will receive Face-to-Face sexual health education in six sessions -90 minutes for 6 weeks with lecture, question-and-answer, and role-playing methods. The sexual health promotion package was designed in 6 steps. 1- Identifying the related factors of sexual dysfunction of these women in a cross-sectional study, 2- Conducting a qualitative study to explaining sexual dysfunction and its related factors in women with MS by conducting interviews with patients and key informants includes psychologists, neurologists, reproductive health, ecologists, and a spouse, 3- Integrating quantitative and qualitative results using the side-by-side method, 4-Designing sexual health promotion strategies in these patients based on Integration results and literature review, 5- Prioritizing these strategies in an experts panel 6-Using these strategies in designing a sexual health promotion package. These packages are based on the patients' needs and include content for patients to learn about and deal with the psychological, physical, sexual symptoms of the disease that affect on improving sexual function, as well as education the communication and negotiation skills with the spouse, problem-solving, education and counseling to enhance sexual intimacy, progressive muscle relaxation, self-esteem, etc.
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Category
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Behavior
2
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Description
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Control group: Women in the control group will not receive any intervention by the research team during the study. This group will attend a one-day sex education workshop and receive a sexual health education package.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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We can share information about the main outcome. The data will spread unknown.
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When the data will become available and for how long
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The data will be an accessible 6-12 month after publishing the results.
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To whom data/document is available
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Researchers in academic institutes were allowed to access data
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Under which criteria data/document could be used
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With stating the reference.
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From where data/document is obtainable
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Sending email to corresponding author through:Msimbar@gmail.com
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What processes are involved for a request to access data/document
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An application letter must include the name of the applicant, used item, the scientific title of the research project or article.
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Comments
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