Protocol summary
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Study aim
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The effect of sexual counseling on couples, on sexual satisfaction and Sexual Function of women with Sexual Interest/Arousal Disorders
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Design
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Randomized Controlled Trial with parallel groups
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Settings and conduct
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Sampling was done online by submitting a call in cyberspace. From applicants who have the inclusion criteria , 40 couples and 40 women with Have SIAD are included in the study. Sampels are randomly divided into two groups of intervention A and B. Both groups receive an educational content virtually.
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Participants/Inclusion and exclusion criteria
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Inclution Criteria:
Having at least three DSM-5 diagnostic criteria For SIAD
having dysfunction for at least 6 months and in ( 75-100%) Of sexual intercourse
having sexual distress
the absence of a recent emotional crisis in life
exclution criteria:
the presence of chronic diseases affecting sexual issues
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Intervention groups
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Sexual counseling based on the GES model, which will include the following content:(An overview of the anatomy and physiology of the female and male reproductive system, the sexual response cycle, the factors influencing this cycle and the factors influencing the reduction of women's sexual desire and the need for sexual self-knowledge ,Explain the importance of sex as an important element of life, creating realistic expectations, emphasizing physical health and healthy behavioral habits on sexual health recovery, training and counseling behavioral exercises (concentration) -counseling to overcome sexual fears and anxieties .In group B , couples and in group A, women are trained. Trainings in both groups are done virtually.
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Main outcome variables
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Sexual Interest And Arousal Disorders
General information
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Reason for update
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Changing In the questionnaires due to the high number of questions, changing the working method and samples due to their unavailability and a slight change in the title
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Acronym
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GES
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IRCT registration information
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IRCT registration number:
IRCT20120609009975N9
Registration date:
2020-06-23, 1399/04/03
Registration timing:
prospective
Last update:
2021-08-05, 1400/05/14
Update count:
2
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Registration date
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2020-06-23, 1399/04/03
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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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2020-12-10, 1399/09/20
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Expected recruitment end date
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2021-03-08, 1399/12/18
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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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Determination of the effect of sexual counseling based on GES model On Sexual satisfaction And Sexual Function of women with Sexual Interest/Arousal Disorders
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Public title
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Determination of the effect of sexual counseling based on GES model On Sexual satisfaction And Sexual Function of women with Sexual Interest/Arousal Disorders
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having at least three DSM-5 diagnostic criteria For SIAD And having problems for at least 6 months And In (100-75%) Of sexual intercourse.
Having Sexual Distress
The presence of an orgasmic disorder that is less important than the SIAD disorder ( if the orgasmic disorder is more important and primary, it goes away).
SIAD disorder is secondary, meaning that the person has not had the problem from the beginning with the question, "Have you felt that your sexual desire has decreased compared to before?" Is measured.
SIAD disorder is generalized, meaning that decreased of Sexual Desire is not just because of the spouse.
Age range 18 years before menopause
Lack of addiction in the participant and his wife
Lack of recent emotional crisis in life
Exclusion criteria:
having depression : Diagnosis with questionnaire 2 PHQ-2 questionnaire
presence of chronic and severe diseases affecting sexual issues
taking any drug that affects sexual desire such as antidepressants
having serious marital problems with the spouse that may lead to divorce
Sexual pain
unwillingness to continue participating in the Intervention
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Age
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From 18 years old to 52 years old
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Gender
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Both
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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:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random assignment to intervention and control groups
Description of Randomization:
First, a list of people who submitted their application to participate in the study within a certain period of time is prepared by the easy access method. Examples of this study are women with SIAD. The required number of samples in this study was 40 couples in group B and 40 women in group A. Among these individuals, who meet the inclusion criteria and are willing to participate in the study are randomly selected. After completing the questionnaires of demographic information, sexual satisfaction(GMSEX), sexual function(FSFI-6), sexual desire (SIDI), sexual distress(FSDS-3) and sexual misconceptions(SBDQ), these Women are randomly divided into two groups of intervention and control based on the table of computer random numbers.
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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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2020-05-02, 1399/02/13
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Ethics committee reference number
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IR.TUMS.FNM.REC.1399.035
Health conditions studied
1
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Description of health condition studied
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Female Sexual Interest/Arousal Disorders
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ICD-10 code
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F52.0
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ICD-10 code description
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Hypoactive sexual desire disorder
2
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Description of health condition studied
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Sexual Dysfunction
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ICD-10 code
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F52
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ICD-10 code description
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Sexual dysfunction not due to a substance or known physiological condition
3
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Description of health condition studied
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Sexual Satisfaction
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ICD-10 code
-
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ICD-10 code description
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Primary outcomes
1
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Description
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Sexual Desire
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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The Sexual Interest And Desire Inventory
2
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Description
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sexual function
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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The Female Sexual Function Index(6)
3
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Description
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The Sexual Satisfaction
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Timepoint
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Before intervention and 3 months after intervention
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Method of measurement
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The Global Measure of Sexual Satisfaction
Secondary outcomes
1
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Description
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How couples Sexualy Interact
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Timepoint
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Before Intervention And 3 Months After The End Of The Intervention
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Method of measurement
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Dyadic Sexual Communication Scale
2
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Description
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Sexual Distress
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Timepoint
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Before Intervention And 3 Months After The End Of The Intervention
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Method of measurement
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Short Version Of Sexual Distress Scale-3
Intervention groups
1
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Description
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Intervention group B: Women receive sexual counseling and training in three sessions (The time of each session is 90 minutes) individually and in a one session(180-minute) with their husbands. Trainings in four weeks, online and Weber based on the concepts of the GES treatment model The content of the first and second sessions includes an overview of anatomy and physiology of the female and male reproductive system, Wrong sexual beliefs, definition of sexual satisfaction and the factors affecting it, dimensions of correct sexual communication ، definition of sexual self-knowledge، Sensate Focus، Sexual self-disclosure, sexual differences between men and women, Sexual Response Cycle، appropriate sexual conditions For Proper Sexual Communication And sexual perversions. the third and fourth sessions on Designing sex based on each couple's circumstances and their desires, ways to diversify sex ،Sexual fantasy، Definition of sexual desire, definition of SIAD disorder, factors affecting sexual desire, description of physical and psychological factors affecting sexual desire، Socio-educational and interpersonal causes affecting sexual desire, ways to cultivate sexual desire are emphasized based on the dimensions of the treatment model.
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Category
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Behavior
2
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Description
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Intervention group B: Women containing sexual education and counseling that includes an overview of the anatomy and physiology of the male and female reproductive system, misconceptions, definition of sexual satisfaction and factors affecting it, dimensions of correct sexual Communication, definition of sexual self-knowledge, sexual self-disclosure, female sexual differences And man, sexual response cycle, appropriate conditions for proper sexual Communication, sexual deviations, designing sexual intercourse based on each couple's circumstances and their desires, methods of creating diversity in sexual intercourse, definition of sexual fantasy, definition of sexual Interest/Arousal Disorders, definition of Sexual desire, factors affecting sexual desire، physical, psychological, socio-educational and interpersonal factors affecting sexual desire are received virtually as in group A in 4 weekly sessions.
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Category
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Behavior
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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Vice Chancellor for research of Tehran University of Medical Science
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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We're going to publish the results and not distribute the data
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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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No - There is not 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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available