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IRCT20211027052886N1 IRCT 2022-03-07 Iran University of Medical Sciences Drug holiday method on sexual function in women treated with selective serotonin reuptake inhibitors The effectiveness of drug holiday method on sexual function in women treated with selective serotonin reuptake inhibitors other than fluoxetine: a randomized clinical trial compared with control group 2022-03-06 anticipated 50 Complete https://irct.ir/trial/61666 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Entry to the study will be based on a block table of random numbers based on quadruple blocks, and each time a person enters the study, the evaluator and his / her importer will be unaware of what group the next person will be in. At any time, during contact with another researcher who has a table of numbers, he will be informed about his entry into the control group or intervention. 2-3 Sexual side effect with SSRIs. Intervention 1: Intervention group: 25 female and married patients undergoing maintenance phase of standard care with one of the selective serotonin reuptake inhibitors, except fluoxetine , enter the study and intervention is that the patient does not take medication for eight weeks on Tuesdays and Fridays. Also, the mental health assessment of patients will be performed on the basis of questionnaire 28 public health questions (GHQ - 28)in the first two turns and the end of the study. The authentication and monitoring of sexual performance is performed by the women's sexual performance index (FSFI). This assessment is a pre - intervention before intervention for all participants, and then they are told to answer all questions of the questionnaire after 4 and then 8 weeks after the study.to increase the degree of participation of participants and higher accuracy of information, every week by the researcher is called on by the researcher and is followed and followed by the pattern of the medication holiday, the incidence of duty, and the fulfillment of the questionnaire. Intervention 2: Control group: 25 female and married patients undergoing maintenance phase of standard care with one of the selective serotonin reuptake inhibitors, except fluoxetine, are studied in the group of control and continue the drug without altering the type and dose of medicine. Also, the mental health assessment of patients will be performed on the basis of questionnaire 28 public health questions (GHQ - 28)in the first two turns and the end of the study. The authentication and monitoring of sexual performance is performed by the women's sexual performance index (FSFI). This assessment is a pre - intervention before intervention for all participants, and then they are told to answer all questions of the questionnaire after 4 and then 8 weeks after the study.to increase the degree of participation of participants and higher accuracy of information, every week by the researcher is called on by the researcher and is followed and followed by the pattern of the medication holiday, the incidence of duty, and the fulfillment of the questionnaire. Yes - There is a plan to make this available What will be shared: Data about main outcome of study will be published When: 2024 To whom: Academic researchers Conditions: For scientific goals Where to obtain: dr.shivasoraya@gmail.com Dr Shiv Sorya How to obtain: Sending an E-mail and reason of request Comments:
public Dr Shiva Soraya
Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1665 dr.shivasoraya@gmail.com Iran University of Medical Sciences scientific Dr Shiva Soraya
Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1665 dr.shivasoraya@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) woman Married lived with husband In maintenance phase of treatment with a SSRI Suffering from sexual side effect 18 years 50 years Female Sexual dysfunction before starting the medication substance dependence and taking another medication with established sexual side effect currently F19.981 Other psychoactive substance use, unspecified with psychoactive substance-induced sexual dysfunction Treatment - Other N/A Intervention group: 25 female and married patients undergoing maintenance phase of standard care with one of the selective serotonin reuptake inhibitors, except fluoxetine , enter the study and intervention is that the patient does not take medication for eight weeks on Tuesdays and Fridays. Also, the mental health assessment of patients will be performed on the basis of questionnaire 28 public health questions (GHQ - 28)in the first two turns and the end of the study. The authentication and monitoring of sexual performance is performed by the women's sexual performance index (FSFI). This assessment is a pre - intervention before intervention for all participants, and then they are told to answer all questions of the questionnaire after 4 and then 8 weeks after the study.to increase the degree of participation of participants and higher accuracy of information, every week by the researcher is called on by the researcher and is followed and followed by the pattern of the medication holiday, the incidence of duty, and the fulfillment of the questionnaire Control group: 25 female and married patients undergoing maintenance phase of standard care with one of the selective serotonin reuptake inhibitors, except fluoxetine, are studied in the group of control and continue the drug without altering the type and dose of medicine. Also, the mental health assessment of patients will be performed on the basis of questionnaire 28 public health questions (GHQ - 28)in the first two turns and the end of the study. The authentication and monitoring of sexual performance is performed by the women's sexual performance index (FSFI). This assessment is a pre - intervention before intervention for all participants, and then they are told to answer all questions of the questionnaire after 4 and then 8 weeks after the study.to increase the degree of participation of participants and higher accuracy of information, every week by the researcher is called on by the researcher and is followed and followed by the pattern of the medication holiday, the incidence of duty, and the fulfillment of the questionnaire Sexual function. Timepoint: Weeks: 0, 4, 8. Method of measurement: Female Sexual Health Questionnaire. Iran University of Medical Sciences Approved 2021-10-22 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences,Next to Milad Tower, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)