Determination of the effect of sexual counseling based on GES model on On Sexual satisfaction And Sexual Function of Couple with Sexual Dysfunction.
Design
Randomized Controlled Trial with parallel groups
Settings and conduct
The sampling center is located in the south of Tehran city. 80 clients who have SIAD enter the study with their husbands.The couple is randomly divided into groups A and B, each of which consists of 40 pairs.couples in Group A receive the same educational content through the Telegram channel in 4 face-to-face sessions And group B receives the same educational content through the Telegram channel.
Participants/Inclusion and exclusion criteria
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:
menopause
the presence of chronic diseases affecting sexual issues
Intervention groups
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, .These trainings are in the A group in the form of face-to-face meetings and in the B group in the virtual form and through the Telegram channel.
Main outcome variables
Sexual Interest And Arousal Disorders
General information
Reason for update
Acronym
GES
IRCT registration information
IRCT registration number:IRCT20120609009975N9
Registration date:2020-06-23, 1399/04/03
Registration timing:prospective
Last update:2020-06-23, 1399/04/03
Update count:2
Registration date
2020-06-23, 1399/04/03
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
2020-09-05, 1399/06/15
Expected recruitment end date
2021-02-03, 1399/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effect of sexual counseling based on GES model on On Sexual satisfaction And Sexual Function of Couple with Sexual Dysfunction
Public title
Determination of the effect of sexual counseling On Sexual satisfaction And Sexual Function of Couple with Sexual Dysfunction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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.
Ability to attend In all training sessions
Age range 18 years before menopause
Spouse presence in the past month provided you have sex
Lack of addiction in the participant and his wife
Lack of recent emotional crisis in life
Exclusion criteria:
Menopause
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
not attending In 2 or more counseling sessions
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Accidental allocation to intervention and control groups:
Describe how to randomize:
Eighty women with SIAD who are eligible to Intervention are selected with their spouses to enter the study. These Couples are then randomly divided into two groups of 40 pairs of intervention A and intervention B using random blocking with the size of four blocks. For random allocation by blocking method and allocating individuals to 2 intervention groups (A) and Intervention B (B), there are six modes for blocks, including: ABAB ،BBAA, AABB, BABA, ABBA and BAAB. We create random numbers using a computer. For the number 1 of the combination 1 (BAAB), for the number 2 the combination 2 (BBAA), for the number 3 of the combination 3 (ABBA), for the number 4 of the combination 4 (ABAB), for the number 5 of the combination 5 (BAAB) and for the number 6 of We use a combination of 6 (AABB).
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
National Committee on Ethics in Biomedical Research
Street address
میدان توحید، خیابان دکتر میرخانی.دانشکده پرستاری و مامایی
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.TUMS.FNM.REC.1399.035
Health conditions studied
1
Description of health condition studied
Female Sexual Interest/Arousal Disorders
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
2
Description of health condition studied
Sexual Dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
3
Description of health condition studied
Sex Counseling
ICD-10 code
Z70.9
ICD-10 code description
Sex counseling, unspecified
Primary outcomes
1
Description
Sexual Interest/Arousal Disorders
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
The Sexual Interest And Desire Inventory
2
Description
sexual function
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
The Female Sexual Function Index
Secondary outcomes
1
Description
How couples Sexualy Interact
Timepoint
Before Intervention And 3 Months After The End Of The Intervention
Method of measurement
Dyadic Sexual Communication Scale
2
Description
Wrong sexual beliefs
Timepoint
Before Intervention And 3 Months After The End Of The Intervention
Method of measurement
The Sexual Dysfunction Beliefs Questionnaire
3
Description
Sexual Distress
Timepoint
Before Intervention And 3 Months After The End Of The Intervention
Method of measurement
The Female Sexual Distress Scale-Revised
4
Description
The Sexual Satisfaction Events
Timepoint
One month Before and one month after the intervention
Method of measurement
Sexual Satisfaction Events
5
Description
Sexual Satisfaction
Timepoint
Before Intervention And 3 Months After The End Of The Intervention
Method of measurement
Index Of Sexual Satisfaction
Intervention groups
1
Description
Intervention Group A: These individuals undergo sexual counseling and training in 4 face-to-face sessions based on the concepts of 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, sexual response cycle, factors Affecting this cycle and the factors influencing the reduction of women's sexual desire and the need for sexual self-knowledge, explaining the importance of sex as an important element of life, the importance of quality and sexual satisfaction in couples' sexual development and the third and fourth sessions on realistic expectations, physical health And healthy behavioral habits to restore sexual health, training and counseling behavioral exercises (concentration), counseling to overcome sexual fears and anxieties, and training to have flexible sexual experiences, etc.) are emphasized based on the dimensions of the treatment model.
Category
Behavior
2
Description
Intervention Group B: These individuals Content of sex education that includes an overview of the anatomy and physiology of the male and female reproductive system, the sexual response cycle, the factors influencing this cycle and the factors affecting the reduction of women's sexual desire and the need for sexual self-knowledge. The title of the important element of life, the importance of quality and sexual satisfaction in sexual development of couples, creating realistic expectations, having physical health and healthy behavioral habits to restore sexual health, training and counseling behavioral exercises (concentration), counseling to overcome fears and Sexual worries and learning to have flexible sexual experiences, etc.) are received through the Telegram channel and virtually.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Southern Health Centers
Full name of responsible person
Farnaz Farnam
Street address
South Kargar Street
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Fax
Email
f_farnam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Science
Full name of responsible person
محمد علی صحرائیان
Street address
Tohid Square، Nosrat st,Tehran, Reproductive Health Department, Tehran University of Medical sciences
City
tehran
Province
Tehran
Postal code
1419733181
Phone
+98 21 6105 4000
Email
zfarahi1374@gmail.com
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
Vice Chancellor for research of Tehran University of Medical Science
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
Zahra Farahi
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
zfarahi1374@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
Dr. Mirkhani St, Tohid Square, School of Nursing and Midwifery,Tehran
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
Zahra Farahi
Position
Master Student of Midwifery
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
zfarahi1374@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
We're going to publish the results and not distribute the data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available