Determine the impact of "good enough sex model" on the sexual satisfaction and sexual intimacy of women with multiple sclerosis.
Design
A clinical trial with a control group, with parallel groups, randomized
Settings and conduct
This study will be conducted on married women with multiple sclerosis in the MS Society of Iran in Tehran. These women are randomly divided into two groups of experimental and control and in the experimental group, educational intervention is performed. The education will take place in three 90-minute sessions, with a one-week interval.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women with MS with sexual activity and lack of other diseases such as cardiovascular, renal, endocrine, autoimmune and psychological disease.
Non-Inclusion criteria:
Individuals who have received research-related educations.
Intervention groups
The intervention group included women with MS who received good enough sex model education. The control group consisted of women with MS who did not receive any education.
Main outcome variables
Sexual Satisfaction; Sexual Intimacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150128020854N6
Registration date:2019-08-12, 1398/05/21
Registration timing:registered_while_recruiting
Last update:2019-08-12, 1398/05/21
Update count:0
Registration date
2019-08-12, 1398/05/21
Registrant information
Name
Hedyeh Riazi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 386 5612
Email address
h.riazi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-24, 1397/10/03
Expected recruitment end date
2019-08-19, 1398/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of “good enough sex model” on sexual satisfaction and sexual intimacy in women with multiple sclerosis
Public title
Effect of “good enough sex model” on sexual satisfaction and sexual intimacy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least reading and writing skills.
Interested in participating in classes and changing sex life.
More than 6 months have passed from their illness.
Having sex with her husband.
They do not have a known mental illness. (According to the woman report)
Do not be in pregnancy or breastfeeding period.
Do not have acute or chronic disease other than multiple sclerosis. (According to the woman report).
In the past six months, they have not experienced marital conflicts. (According to the woman report)
Age between 20-45 years.
The severity of the disease does not interfere with sexual function and participation in the classes.
Do not have depression or anxiety. (Based on the medical records in the MS forum)
Exclusion criteria:
Unwillingness to participate in research.
Individuals who have received research-related educations.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
First, the participants were given two-digit codes from 01 to 90. Then, using the website www.Randomization.com, the statistical consultant provided two sets of codes, the first set assigned as the intervention group and the second, control group.
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
Nursing and Midwifery school, in front of Shahid Rajai Hospital, cross of Niyayesh, Vali Asr Avenue.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.180
Health conditions studied
1
Description of health condition studied
Sex Counseling
ICD-10 code
Z70.1
ICD-10 code description
Counseling related to patient's sexual behavior and orientation
Primary outcomes
1
Description
Sexual intimacy
Timepoint
Before intervention and 1 month after the end of intervention
Method of measurement
Larson's sexual intimacy questionnaire
2
Description
Sexual satisfaction
Timepoint
Before intervention and 1 month after the end of intervention
Method of measurement
Botlani's questionnaire of sexual satisfaction
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: After completing the written consent form, the Larsson Sexual Satisfaction Questionnaire and Botlani et al, Sexual Intimacy Questionnaire were completed by participants as a pre-test. Intervention is the education of the "good enough sex model" for married women with multiple sclerosis during three sessions. The duration of each session is 90 minutes. Classes will be held with one-week intervals. Educational content provided to intervention group: Session 1: The sexual response cycle includes stages of desire, motivation, orgasm, submission; Principles 1 to 3 of GESM include understanding the complexity of sexual disorders, accepting disease and having real expectations, and emphasizing on the quality of sex, and providing relevant assignments including how to change consciousness and belief on the sex lifestyle after the first session and the scenario design of sex with consideration and acceptance of changes caused by MS. Session 2: Assessment of the preceding session; Principles 4 to 6 of GESM which include understanding the importance of relationship between couples in quality of sex and targeting new sex lifestyle, deeper education on more complex problems, and observing therapeutic and psychological aspects of the disease according to their physician; GESM components 1–6 include understanding the positive importance of sex, being in a cohesive team, the importance of physical health in couples, and realistic sexual expectations based on strong emotional connection, belief in change, the importance of sexual quality rather than emphasis on quantity and importance. Satisfaction with each stage of sex without emphasizing on orgasm in sexual intercourse Relevant qualifications include exchanging thoughts and thinking with your spouse about the time, place, and behavior to achieve excitement, relaxation, and changes in the sexual response process.Session 3: Assessment of the assignments; GESM 7-12 components training includes flexible attitude towards pleasant sexual experiences of being together, setting new presexual activity targets based on new attitudes formed with emphasis on maximum pleasure catching according to the present situation, the use of emotional styles in sex such as interacting with a spouse, sexual fantasy and role-playing, accepting each other's wishes, enriching the sex, and forming the concept of sex in each other as a value in marital life and presenting relevant tasks, including telling their feelings about the stages of the sexual response cycle for each other. Two weeks after intervention, Larson's Sexual Satisfaction and Botlani et al Sexual Intimacy Questionnaires were again completed by the subjects and compared with the pre-test.
Category
Other
2
Description
Control Group: After completing the written consent form, the Larsson Sexual Satisfaction Questionnaire and Botlani et al, Sexual Intimacy Questionnaire were completed by participants as a pre-test.After receiving no information and educational intervention in the field of sex after 35 days, Larson Sexual Satisfaction and Botlani et al Sexual Intimacy Questionnaires were again completed by control group and compared with pretest.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran's MS Society
Full name of responsible person
Abdolhosein Hooshmand
Street address
Vesal-Shirazi
City
Tehran
Province
Tehran
Postal code
1416864731
Phone
+98 21 6695 1187
Email
iranmsociety@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Valiasr
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Email
sbnmf@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Jamalian Far
Position
Ms student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Valiasr
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 912 814 8156
Email
fjf.jamalian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hedyeh Riazi
Position
Ph.D in Reproductive Health/Academic member of Midwifery and Reproductive Health Department
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Valiasr
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Email
h.riazi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Jamalian Far
Position
Mrs
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
ValiAsr Ave., Cross of Niayesh Highway and ValiAsr. School of Nursing and Midwifery. .
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 912 814 8156
Email
fjf.jamalian@gmail.com
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
Because the results will be mentioned in the article.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study protocol
When the data will become available and for how long
After publishing the article from the study
To whom data/document is available
All interested colleagues
Under which criteria data/document could be used
To use in other studies
From where data/document is obtainable
Mrs. Fatemeh Jamalianfar
What processes are involved for a request to access data/document