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Investigating the effect of sexual counseling on sexual disorders of women with depression using SSRIs

Protocol summary

Study aim
Determining the effect of sexual counseling on sexual disorders of depressed women taking SSRI drugs
Design
Clinical trial with control group, intervention, block randomization, 43 people in the intervention group, 43 people in the control group
Settings and conduct
In Shahid Beheshti Hospital, Kerman, depressed women taking the drugs we are looking for, who have experienced sexual dysfunction due to drug use, are identified by filling in the FSFI questionnaire, and if they meet the conditions for entering the study, they are randomly divided into two intervention and control groups. People in the intervention group will undergo weekly sexual counseling sessions. After the sessions, both groups will fill out the questionnaire again.
Participants/Inclusion and exclusion criteria
Entry conditions: age between 18-50 years, having sexual activity in the past 1 year, living with a spouse for more than a year, the spouse being the only sexual partner, not having a sexual disorder before starting to take SSRIs, single-drug treatment for at least one month by the SSRI class of drugs. Having regular menstruation, not suffering from medical diseases, not using drugs and alcohol, sexual abuse, not suffering from all kinds of sexually transmitted diseases Conditions of non-entry: non-regular use of medication, suffering from major depression and bipolar disease, use of drug therapy or other counseling, pregnancy or divorce, breastfeeding, non-participation in meetings
Intervention groups
The effect of sexual counseling on sexual disorders of depressed women using SSRIs in the intervention group and no counseling in the control group and just filling in the questionnaire
Main outcome variables
Sexual function score(Reducing sexual dysfunction)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240414061484N1
Registration date: 2024-04-16, 1403/01/28
Registration timing: prospective

Last update: 2024-04-16, 1403/01/28
Update count: 0
Registration date
2024-04-16, 1403/01/28
Registrant information
Name
Zahra Shad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4224 4343
Email address
za_shad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sexual counseling on sexual disorders of women with depression using SSRIs
Public title
Effect of sexual counseling on sexual disorders caused by using SSRI drugs
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 50 years Being married Having Iranian nationality Having sexual activity in the last 12 months Be living with her husband and be the only partner of her husband and spend one year or more of her married life. Not having sexual dysfunction before starting to take SSRI Suffering from sexual dysfunction after consumption Single drug treatment for at least one month by SSRI drugs Having regular menstruation Absence of medical diseases that cause sexual dysfunction, such as any cardiovascular, nervous, metabolic and endocrine, severe respiratory, rheumatological, psychological diseases. No history of drug and alcohol abuse Absence of sexual abuse during life Absence of sexually transmitted diseases
Exclusion criteria:
Not using medicine regularly and not taking it for at least three days In case of suffering from major depression and bipolar disease according to the doctor's diagnosis Being in perimenopause In case of getting pregnant or divorce from a sexual partner Breastfeeding
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: 86
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is in block form. (It is not a simple randomization). First, the intervention group is indicated by the letter "A" and the control group is indicated by the letter "B". In this method, with block allocation, people are placed in groups in a balanced and random manner, and it is determined in which group each person who enters the study is placed by using R statistical software. "BABA" "BAAB" "AABB" "BAAB" "ABBA" "AABB" "AABB" "ABBA" "ABAB" "ABBA" "ABAB" "AABB" "BBAA" "ABAB" "BBAA" "AABB" "ABBA" "BBAA" "BABA" "BAAB" "BABA" "BA" 21 blocks of 4 pieces and one block of 2 pieces The program codes are as follows y<-c ("AABB", "BBAA", "ABAB", "BABA", "ABBA", "BAAB") x<-sample (y,22, replace=TRUE) x
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 Kerman University of Medical Sciences Et
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.KMU.REC.1402.455

Health conditions studied

1

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

Primary outcomes

1

Description
Sexual function score in FSFI questionnaire
Timepoint
When entering the study and after completing the counseling sessions
Method of measurement
Female Sexual Function Index questionnaire(FSFI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The FSFI questionnaire will be given to depressed women who refer to Shahid Beheshti Hospital clinic who are treated with SSRI drugs. Sufficient time (20 to 30 minutes) will be considered to complete the questionnaire. After that, the people who will get the necessary points to enter the study from the questionnaire, that is, they will have sexual dysfunction and meet the criteria for entering the study, will be entered into the study. These people will be randomly divided into intervention and control groups. The intervention group will receive four two-hour sessions (weekly) of in-person sex counseling at the hospital meeting hall. After the counseling sessions, the FSFI questionnaire will be given to all participants and they will be asked to complete it. The difference between the sexual performance score will indicate the effectiveness of counseling.
Category
Behavior

2

Description
Control group: The FSFI questionnaire will be available to depressed women referred to the Shahid Beheshti Hospital clinic who are being treated with SSRI drugs. Sufficient time (20 to 30 minutes) will be considered to complete the questionnaire. After that, the people who will get the necessary points to enter the study from the questionnaire, that is, they will have sexual dysfunction and meet the criteria for entering the study, will be entered into the study. These people will be randomly placed in two intervention and control groups. People in the control group will not receive any counseling and only after the counseling sessions of the intervention group, the control group will fill the questionnaire again.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital Clinic
Full name of responsible person
Zahra Shad
Street address
27 Ave.,Jomhouri Eslami Blv
City
Kerman
Province
Kerman
Postal code
76188 34115
Phone
+98 34 3211 0408
Email
za_shad@yahoo.com
Web page address
https://shbh.kmu.ac.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Deputy of research and technology., Somayeh Crossroads
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
za_shad@yahoo.com
Web page address
https://shbh.kmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Firoozeh Mirzaee
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
f_mirzaee@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firoozeh Mirzaee
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
f_mirzaee@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firoozeh Mirzaee
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
f_mirzaee@kmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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