The effect of education of sexual health promotion package on sexual function and sexual quality of life in multiple sclerosis women: designed from the results of a mixed-method study
The effect of education of sexual health promotion package on sexual function and sexual quality of life in multiple sclerosis women
Design
This study is a randomized controlled clinical trial, and 72 women with multiple sclerosis will be randomly assigned into two intervention and control groups.
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Sexual function 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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190721044292N1
Registration date:2019-09-01, 1398/06/10
Registration timing:prospective
Last update:2019-09-01, 1398/06/10
Update count:1
Registration date
2019-09-01, 1398/06/10
Registrant information
Name
Vida Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
vidaghasemi89@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education of sexual health promotion package on sexual function and sexual quality of life in multiple sclerosis women: designed from the results of a mixed-method study
Public title
The effect of sexual health education on sexual function and sexual quality of life in women with multiple sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by using random numbers in Excel software (Rand () function).
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velenjak.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.SBMU.PHNM.1396.1003
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 function
Timepoint
Before the intervention, immediately after the intervention and two months after the intervention
Method of measurement
Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19)
2
Description
Sexual Quality of life
Timepoint
Before the intervention, immediately after the intervention and two months after the intervention
Method of measurement
sexual quality of life-female (SQOL-F) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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 function of these women in a cross-sectional study, 2- Conducting a qualitative study to explaining sexual function and its related factors in women with MS by conducting interviews with patients and key informants includes psychologists, neurologists, reproductive health, sexologists and a spouse, 3- Integrating quantitative and qualitative results using 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 a experts panel 6-Using these strategies in designing a sexual health promotion package. These packages is based on the patients' needs and includes content for patients to learn about and deal with the psychological, physical, sexual symptoms of disease that affect 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.
Category
Behavior
2
Description
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.