Effect of sexual counseling based on the good enough sex (GES) model on the sexual health and reproductive behavior of couples in two groups with and without the presence of the husband (male partner).
Effect of sexual counseling based on the good enough sex (GES) model on the sexual health and reproductive behavior of couples in two groups with and without the presence of the husband (male partner).
Design
Randomized Controlled Trial with parallel groups
Settings and conduct
Sampling is done through the names in the Sib system(NIH). 100 couples are included in the study from the couples who meet the entry criteria. They are randomly divided into two intervention groups A and B. Both groups receive the same educational content virtually.
Participants/Inclusion and exclusion criteria
Entry criteria: being married, the length of marriage maximum 1-5 years (not counting the years of marriage), the presence of the spouse at least two weeks a month, the ability to use smart devices, being in the reproductive age of 18-49 years, the willingness of the spouse to participate in the meetings. Exclusion criteria: women being pregnant and breastfeeding, having sexual interventions or counseling in the last 6 months, taking drugs affecting sexual activity, suffering from sexual disorders and chronic diseases affecting sexual issues in the person or his wife, serious emotional problems with his wife, drug addiction Participants and the presence of emotional crisis in life.
Intervention groups
Sexual counseling based on the GES model to investigate its effectiveness on the sexual health of couples as primary outcomes, the desire to have children and the reduction of problematic sexual behaviors (following the improvement of sexual health) as secondary outcomes.
Main outcome variables
sexual satisfaction, sexual function, sexual communication, sexual Distress, number of sexual intercourse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120609009975N11
Registration date:2023-12-26, 1402/10/05
Registration timing:prospective
Last update:2023-12-26, 1402/10/05
Update count:0
Registration date
2023-12-26, 1402/10/05
Registrant information
Name
Farnaz Farnam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4217
Email address
fz.farnam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sexual counseling based on the good enough sex (GES) model on the sexual health and reproductive behavior of couples in two groups with and without the presence of the husband (male partner).
Public title
Effect of sexual counseling based on the good enough sex (GES) model on the sexual health and reproductive behavior of couples in two groups with and without the presence of the husband (male partner).
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being married
Duration of marriage 1-5 years
Presence of the spouse at least two weeks a month
The ability to work with smart devices
Age 18-49 years
The husband's willingness to engage in intervention sessions.
Exclusion criteria:
Women being pregnant and breastfeeding at the time of entering the study and receiving consultations
Having sexual interventions or counseling in the last 6 months
Taking drugs that affect sexual activity
Suffering from sexual disorders and chronic disease affecting sexual issues (according to self-report)
Having serious emotional problems with your spouse
Addiction in the participants (according to self-report)
Existence of emotional crisis in life
Age
From 18 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, a list of couples who are in the initial 1-5 years of their marriage is prepared through the names in the Sib system. The samples of this study consist of all healthy couples who are in the initial 1-5 years of their marriage. The required number of samples in this study is 100 couples, with 50 couples in intervention group A and 50 couples in intervention group B. From this list, 100 couples are selected in a systematic manner and contacted via telephone. Those who meet the entry criteria and express a willingness to participate in the study will be enrolled. After completing the questionnaires on demographic information, sexual satisfaction, sexual function, sexual communication, problematic pornography, and the value of having a child, these couples are divided into two intervention and control groups using a computerized random block method (blocks of 4).
Blinding (investigator's opinion)
Single blinded
Blinding description
The data will be analyzed by an individual outside the research team therefore in this study the data analyst will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee In Research, School of Nursing And Midwifery, Tehran University of Medical Sciences
Street address
School of Nursing Midwifery, Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2023-12-19, 1402/09/28
Ethics committee reference number
IR.TUMS.FNM.REC.1402.182
Health conditions studied
1
Description of health condition studied
sexual Health
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Reproductive behavior
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of Sexual Satisfaction in the Sexual Satisfaction Questionnaire (GMSEX)
Timepoint
At the beginning of the study (before intervention) and 3 months after the intervention..
Method of measurement
The Global Measure of Sexual Satisfaction (GMSEX)
2
Description
Sexual Performance Score in the Arizona Sexual Experience Scale (ASEX-6)
Timepoint
At the beginning of the study (before intervention) and 3 months after the intervention.
Method of measurement
Arizona Sexual Experience Scale (ASEX-6)
3
Description
Sexual Communication Score in the Dyadic sexual communication scale
Timepoint
At the beginning of the study (before intervention) and 3 months after the intervention.
Method of measurement
Dyadic sexual communication scale
4
Description
Sexual Distress Score in the Female Sexual Distress Scale (FSDS) scale
Timepoint
At the beginning of the study (before intervention) and 3 months after the intervention.
Method of measurement
Female Sexual Distress Scale (FSDS) scale
5
Description
Number of sexual intercourse
Timepoint
At the beginning of the study (before intervention) and 3 months after the intervention.
Method of measurement
In the last 3 months, how many intercourse (vaginal, oral or anal) have you had?”
Secondary outcomes
1
Description
Sources of sexual information
Timepoint
At the beginning of the study (before intervention) and 3 months after the intervention.
Method of measurement
Question "What sources do you use to get sexual information and improve marital relations"?
2
Description
Use of explicit sexual content
Timepoint
At the beginning of the study (before intervention) and 3 months after the intervention.
Method of measurement
Question: "Do you use sexually explicit content or not"?
3
Description
Extramarital Sexual Relationship Question
Timepoint
At the beginning of the study (before intervention) and 3 months after the intervention.
Method of measurement
ُSingle question “During the last 12 months, have you had sex with a person (or persons) other than your wife/husband (or the partner that you are in relation)? (Yes/no/ I do not want to answer)”.
4
Description
Compulsion and sexual obsession
Timepoint
At the beginning of the study (before intervention) and 3 months after the intervention.
Method of measurement
Question "Do you feel compulsion or obsession for sexual relations or using sexually explicit content or not"?
5
Description
Score of childbearing intention in the childbearing intention Questionnaire.
Timepoint
At the beginning of the study (before intervention) and 3 months after the intervention.
Method of measurement
childbearing intention Questionnaire.
Intervention groups
1
Description
Intervention group A: Women will individually participate in 4 weekly online sessions, each lasting 90 minutes, to receive sexual education and counseling based on the GES model. The educational content includes؛ a review of the anatomy and physiology of the male and female reproductive systems, addressing misconceptions about sexuality, defining sexual satisfaction and its influencing factors, exploring dimensions of healthy sexual communication, understanding sexual self-awareness, sexual self-disclosure, recognizing sexual differences between genders, understanding the sexual response cycle, identifying optimal conditions for healthy sexual interactions, discussing sexual deviations, designing sexual relationships based on each couple's circumstances and desires, methods for introducing variety into sexual relationships, defining sexual fantasies, understanding sexual desire, defining hypoactive sexual desire disorder and sexual arousal disorders, discussing factors influencing sexual desire, and elucidating the physical, psychological, socio-educational, and interpersonal factors that impact sexual desire.
Category
Behavior
2
Description
Intervention group B: Women will be educated according to the GES model in 2 individual sessions and in 2 sessions with their husbands. Each session will have a duration of 90 minutes. The sessions will be conducted online, with one session per week. The content of the first and second sessions encompasses a review of the anatomy and physiology of the male and female reproductive systems, addressing misconceptions about sexuality, defining sexual satisfaction and its influencing factors, exploring dimensions of healthy sexual communication and sexual self-awareness, sexual self-disclosure, understanding sexual differences between genders, the sexual response cycle, identifying optimal conditions for healthy sexual interactions, and discussing sexual deviations. The third and fourth sessions will focus on designing sexual relationships tailored to each couple's circumstances and desires, methods for introducing variety into sexual relationships, defining sexual fantasies, understanding sexual desire, defining hypoactive sexual desire disorder and sexual arousal disorders, discussing factors influencing sexual desire, elaborating on physical and psychological factors affecting sexual desire, and describing socio-educational and interpersonal factors influencing sexual desire.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Farman Farmayan Health Center
Full name of responsible person
Mrs. Qaragozi
Street address
Farman Farmayan Clinic, in front of National Bank, between Golshan and Bastan Streets, Azarbaijan Street, District 11, Tehran
City
Tehran
Province
Tehran
Postal code
1318618311
Phone
+98 21 6683 6325
Email
Behdasht-Jonoob-Tehran@sina.tums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Ahmadi Health Center
Full name of responsible person
Ali Akbar Bakhtiari
Street address
No. 8, Saleh Nia Crossroads, Zamzam District 17, Tehran
City
Tehran
Province
Tehran
Postal code
کد پستی :1367819651
Phone
+98 21 5582 4030
Email
Behdasht-Jonoob-Tehran@sina.tums.ac.ir
3
Recruitment center
Name of recruitment center
Ebne Sina Health center
Full name of responsible person
Ajoudani
Street address
No. 59, Khorramshahr Crossroads, Mehboob Majaz (Sina) St., Nawab Highway, Special Neighborhood, District 11, Tehran
City
Tehran
Province
Tehran
Postal code
1331895311
Phone
+98 21 5541 7562
Email
Behdasht-Jonoob-Tehran@sina.tums.ac.ir
4
Recruitment center
Name of recruitment center
Shahid Ahmadi city health center number two
Full name of responsible person
Kheimehgar
Street address
No. 53, Azizbabai Alley, Jihad St., Zamzam, District 17, Tehran
City
Tehran
Province
Tehran
Postal code
1331895311
Phone
+98 21 5585 5239
Email
Behdasht-Jonoob-Tehran@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari sari
Street address
Keshavarz Boulevard. Central building of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733181
Phone
+98 21 4291 1405
Email
tumspr@tums.ac.ir
Web page address
http://fnm.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Rezvan Zarei
Position
Master of Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing Midwifery, Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
zareirezvan794@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnaz Farnam
Position
Assistant Professor in Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing Midwifery, Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
f_farnam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rezvan Zarei
Position
Master Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Dr. Mirkhani St, Tohid Square, School of Nursing and Midwifery,Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
zareirezvan794@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
Due to the sensitivity of the subject of the study, the publication of the data file of the participants even without names is not considered at this time. If the journal requests to store data in the data bank, this will be done.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study protocol article will be sent to the journal after receiving the IRCT code.
When the data will become available and for how long
Access will start after the article is printed.
To whom data/document is available
Scientific researchers and health care center staff
Under which criteria data/document could be used
Observance of article citation rules
From where data/document is obtainable
Farnaz Farnam (Assistant Professor, Tehran University of Medical Sciences) fz.farnam@gmail.com
Zareirezvan794@gmail.com
What processes are involved for a request to access data/document