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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Protocol summary
The effect of education of sexual health promotion package on sexual function and sexual quality of life in multiple sclerosis women
The effect of education of sexual health promotion package on sexual dysfunction and sexual quality of life in multiple sclerosis women
The effect of education of sexual health promotion package on sexual functiondysfunction and sexual quality of life in multiple sclerosis women
بررسی تاثیر آموزش بسته ارتقا سلامت جنسی بر عملکرد جنسی و کیفیت زندگی جنسی زنان مبتلا به مولتیپل اسکلروزیس
بررسی تاثیر آموزش بسته ارتقا سلامت جنسی بر اختلال عملکرد جنسی و کیفیت زندگی جنسی زنان مبتلا به مولتیپل اسکلروزیس
بررسی تاثیر آموزش بسته ارتقا سلامت جنسی بر اختلال عملکرد جنسی و کیفیت زندگی جنسی زنان مبتلا به مولتیپل اسکلروزیس
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.
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.
Sexual functiondysfunction with Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19) and sexual quality of life with sexual quality of life-female (SQOL-F) questionnaire.
عملکرد جنسی با استفاده از پرسشنامه 19 سوالی صمیمیت و فعالیت جنسی در بیماری مولتیپل اسکلروزیس (MSISQ-19) و کیفیت زندگی جنسی با استفاده از پرسشنامه کیفیت زندگی جنسی زنان
اختلال عملکرد جنسی با استفاده از پرسشنامه 19 سوالی صمیمیت و فعالیت جنسی در بیماری مولتیپل اسکلروزیس (MSISQ-19) و کیفیت زندگی جنسی با استفاده از پرسشنامه کیفیت زندگی جنسی زنان
اختلال عملکرد جنسی با استفاده از پرسشنامه 19 سوالی صمیمیت و فعالیت جنسی در بیماری مولتیپل اسکلروزیس (MSISQ-19) و کیفیت زندگی جنسی با استفاده از پرسشنامه کیفیت زندگی جنسی زنان
General information
empty
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.
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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کلمه "عملکرد جنسی" به "اختلال عملکرد جنسی" تغییر یافت. این تغییر به این علت صورت گرفت که پرسشنامه MSISQ-19 "اختلال عملکرد جنسی" را می سنجد و قبلا اشتباها عملکرد جنسی ذکر شده بود. لازم به ذکر است در روند اجرا هیچ تغییری در ساختار مطالعه اعمال نشد و تنها
کلمه "عملکرد جنسی" به "اختلال عملکرد جنسی" تغییر یافت.
همچنین به منظور بررسی دقیقتر تاثیر مداخله، یک نوبت دیگر پیگیری در 1 ماه بعد از مداخله نیز اضافه شدو تایم های پیگیری به بلافاصله، 1 ماه و 2 ماه بعد از مداخله تغییر یافت.
کلمه "عملکرد جنسی" به "اختلال عملکرد جنسی" تغییر یافت. این تغییر به این علت صورت گرفت که پرسشنامه MSISQ-19 "اختلال عملکرد جنسی" را می سنجد و قبلا اشتباها عملکرد جنسی ذکر شده بود. لازم به ذکر است در روند اجرا هیچ تغییری در ساختار مطالعه اعمال نشد و تنها کلمه "عملکرد جنسی" به "اختلال عملکرد جنسی" تغییر یافت. همچنین به منظور بررسی دقیقتر تاثیر مداخله، یک نوبت دیگر پیگیری در 1 ماه بعد از مداخله نیز اضافه شدو تایم های پیگیری به بلافاصله، 1 ماه و 2 ماه بعد از مداخله تغییر یافت.
The effect of sexual health education on sexual function and sexual quality of life in women with multiple sclerosis
The effect of sexual health education on sexual dysfunction and sexual quality of life in women with multiple sclerosis
The effect of sexual health education on sexual functiondysfunction and sexual quality of life in women with multiple sclerosis
تاثیر آموزش سلامت جنسی بر عملکرد و کیفیت زندگی جنسی در زنان مبتلا به مولتیپل اسکلروزیس
تاثیر آموزش سلامت جنسی بر اختلال عملکرد و کیفیت زندگی جنسی در زنان مبتلا به مولتیپل اسکلروزیس
تاثیر آموزش سلامت جنسی بر اختلال عملکرد و کیفیت زندگی جنسی در زنان مبتلا به مولتیپل اسکلروزیس
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 dysfunction 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 functiondysfunction and sexual quality of life in multiple sclerosis women: designed from the results of a mixed-method study
بررسی تاثیر آموزش بسته ارتقا سلامت جنسی بر عملکرد جنسی و کیفیت زندگی جنسی زنان مبتلا به مولتیپل اسکلروزیس: طراحی شده از نتایج یک مطالعه ی ترکیبی
بررسی تاثیر آموزش بسته ارتقا سلامت جنسی بر اختلال عملکرد جنسی و کیفیت زندگی جنسی زنان مبتلا به مولتیپل اسکلروزیس: طراحی شده از نتایج یک مطالعه ی ترکیبی
بررسی تاثیر آموزش بسته ارتقا سلامت جنسی بر اختلال عملکرد جنسی و کیفیت زندگی جنسی زنان مبتلا به مولتیپل اسکلروزیس: طراحی شده از نتایج یک مطالعه ی ترکیبی
Primary outcomes
#1
Sexual function
Sexual dysfunction
Sexual functiondysfunction
عملکرد جنسی
اختلال عملکرد جنسی
اختلال عملکرد جنسی
Before the intervention, immediately after the intervention and two months after the intervention
Before the intervention, immediately after the intervention, one and two months after the intervention
Before the intervention, immediately after the intervention, one and two months after the intervention
قبل از مداخله، بلافاصله بعد از اتمام مداخله و دو ماه بعد از اتمام مداخله
قبل از مداخله، بلافاصله بعد از اتمام مداخله، 1ماه و دو ماه بعد از اتمام مداخله
قبل از مداخله، بلافاصله بعد از اتمام مداخله، 1ماه و دو ماه بعد از اتمام مداخله
#2
Before the intervention, immediately after the intervention and two months after the intervention
Before the intervention, immediately after the intervention , one and two months after the intervention
Before the intervention, immediately after the intervention , one and two months after the intervention
قبل از مداخله، بلافاصله بعد از اتمام مداخله و دو ماه بعد از اتمام مداخله
قبل از مداخله، بلافاصله بعد از اتمام مداخله، 1 ماه و دو ماه بعد از اتمام مداخله
قبل از مداخله، بلافاصله بعد از اتمام مداخله، 1 ماه و دو ماه بعد از اتمام مداخله
Intervention groups
#1
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.
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.
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 functiondysfunction of these women in a cross-sectional study, 2- Conducting a qualitative study to explaining sexual functiondysfunction and its related factors in women with MS by conducting interviews with patients and key informants includes psychologists, neurologists, reproductive health, sexologistsecologists, 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 aan experts panel 6-Using these strategies in designing a sexual health promotion package. These packages isare based on the patients' needs and includesinclude 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.
زنان مبتلا به مولتیپل اسکلروزیس در گروه مداخله، بصورت چهره به چهره 6 جلسه 90 دقیقه ای آموزش سلامت جنسی را به مدت 6 هفته با روش های سخنرانی، پرسش و پاسخ و ایفای نقش دریافت خواهند کرد. طراحی بسته ی آموزشی طی 6 مرحله انجام شد. 1- مشخص نمودن عوامل مرتبط با عملکرد جنسی این زنان در یک مطالعه مقطعی ، 2- انجام یک مطالعه کیفی برای تبیین عملکرد جنسی و عوامل مرتبط با آن در زنان مبتلا به مولتیپل اسکلروزیس از دید بیماران و مطلعین کلیدی شامل روانشناسان، متخصصین نورولوژی، بهداشت باروری، سکسولوژیست و یک همسر ، 3- تلفیق نتایج مرحله کمی و کیفی به روش یک به یک، 4-طراحی راهکارهای ارتقا دهنده سلامت جنسی در این بیماران بر اساس نتایج تلفیق و مروری بر متون، 5- اولویت بندی این راهکارها در یک جلسه پانل متخصصین 6-استفاده از این راهکارها در طراحی بسته ی آموزشی ارتقا دهنده سلامت جنسی. محتوای مداخله مبتنی بر نیاز خود بیماران بوده و دربرگیرنده ی مطالبی برای آشنایی بیماران و نحوه ی مقابله آنان با علائم روانی، جسمی، جنسی ناشی از بیماری تاثیر گذار بر عملکرد جنسی و همچنین آموزش مهارت های ارتباطی و مذاکره ای با همسر، حل مساله، آموزش و مشاوره جهت تقویت صمیمت جنسی زوجین، آرامسازی پیشرونده عضلانی، تقویت اعتماد بنفس و .... می باشد.
زنان مبتلا به مولتیپل اسکلروزیس در گروه مداخله، بصورت چهره به چهره 6 جلسه 90 دقیقه ای آموزش سلامت جنسی را به مدت 6 هفته با روش های سخنرانی، پرسش و پاسخ و ایفای نقش دریافت خواهند کرد. طراحی بسته ی آموزشی طی 6 مرحله انجام شد. 1- مشخص نمودن عوامل مرتبط با اختلال عملکرد جنسی این زنان در یک مطالعه مقطعی ، 2- انجام یک مطالعه کیفی برای تبیین اختلال عملکرد جنسی و عوامل مرتبط با آن در زنان مبتلا به مولتیپل اسکلروزیس از دید بیماران و مطلعین کلیدی شامل روانشناسان، متخصصین نورولوژی، بهداشت باروری، سکسولوژیست و یک همسر ، 3- تلفیق نتایج مرحله کمی و کیفی به روش یک به یک، 4-طراحی راهکارهای ارتقا دهنده سلامت جنسی در این بیماران بر اساس نتایج تلفیق و مروری بر متون، 5- اولویت بندی این راهکارها در یک جلسه پانل متخصصین 6-استفاده از این راهکارها در طراحی بسته ی آموزشی ارتقا دهنده سلامت جنسی. محتوای مداخله مبتنی بر نیاز خود بیماران بوده و دربرگیرنده ی مطالبی برای آشنایی بیماران و نحوه ی مقابله آنان با علائم روانی، جسمی، جنسی ناشی از بیماری تاثیر گذار بر بهبود عملکرد جنسی و همچنین آموزش مهارت های ارتباطی و مذاکره ای با همسر، حل مساله، آموزش و مشاوره جهت تقویت صمیمت جنسی زوجین، آرامسازی پیشرونده عضلانی، تقویت اعتماد بنفس و .... می باشد.
زنان مبتلا به مولتیپل اسکلروزیس در گروه مداخله، بصورت چهره به چهره 6 جلسه 90 دقیقه ای آموزش سلامت جنسی را به مدت 6 هفته با روش های سخنرانی، پرسش و پاسخ و ایفای نقش دریافت خواهند کرد. طراحی بسته ی آموزشی طی 6 مرحله انجام شد. 1- مشخص نمودن عوامل مرتبط با اختلال عملکرد جنسی این زنان در یک مطالعه مقطعی ، 2- انجام یک مطالعه کیفی برای تبیین اختلال عملکرد جنسی و عوامل مرتبط با آن در زنان مبتلا به مولتیپل اسکلروزیس از دید بیماران و مطلعین کلیدی شامل روانشناسان، متخصصین نورولوژی، بهداشت باروری، سکسولوژیست و یک همسر ، 3- تلفیق نتایج مرحله کمی و کیفی به روش یک به یک، 4-طراحی راهکارهای ارتقا دهنده سلامت جنسی در این بیماران بر اساس نتایج تلفیق و مروری بر متون، 5- اولویت بندی این راهکارها در یک جلسه پانل متخصصین 6-استفاده از این راهکارها در طراحی بسته ی آموزشی ارتقا دهنده سلامت جنسی. محتوای مداخله مبتنی بر نیاز خود بیماران بوده و دربرگیرنده ی مطالبی برای آشنایی بیماران و نحوه ی مقابله آنان با علائم روانی، جسمی، جنسی ناشی از بیماری تاثیر گذار بر بهبود عملکرد جنسی و همچنین آموزش مهارت های ارتباطی و مذاکره ای با همسر، حل مساله، آموزش و مشاوره جهت تقویت صمیمت جنسی زوجین، آرامسازی پیشرونده عضلانی، تقویت اعتماد بنفس و .... می باشد.
Protocol summary
Study aim
The effect of education of sexual health promotion package on sexual dysfunction 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 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
Reason for update
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.
Acronym
IRCT registration information
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
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 dysfunction 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 dysfunction 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 dysfunction
Timepoint
Before the intervention, immediately after the intervention, one 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 , one and two months after the intervention
Method of measurement
sexual quality of life-female (SQOL-F) questionnaire
Secondary outcomes
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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 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.
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.