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IRCT20180826040862N1 IRCT 2019-01-07 Qazvin University of Medical Sciences The Effect of Sex Counseling on Sexual Satisfaction in Women with Cyclic breast pain Sexual Satisfaction after Psychosexual Counselling in Women with Cyclic Mastalgia: An Intervention Study based on the PLISSIT Model 2018-09-23 anticipated 90 Complete https://irct.ir/trial/33492 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: This study consists of two groups witch one group receiving the intervention, Randomization description: The assignment of women with cyclic mastalgia into groups of intervention and control follows the method of simple randomization. According to this method, in each treatment center, a pool with letters of either A or B kept within sealed envelopes will be considered. The number of envelopes matches the number of subjects in the study. Envelopes will be drawn from the pool without replacement by each subject who enters the study. N/A Cyclic Mastalgia, Sexual Satisfaction. Intervention 1: Intervention group: First, questionnaires will be completed by patients. This then will be followed by four one to one in-person counselling sessions. Sessions take place on a weekly basis and each lasts for 90 minutes. According to the PLISSIT model, sessions are summarised as follows: Session 1: Patient administration. During this session, the history of breast pain and sexual discomforts of the patient will be recorded.Session 2: Patient will receive a brief anatomical and physiological summary of limbs and breast.Session 3: Explicit recommendations. At this session, consultation on specific concerns such as fundamental sexual related concepts and training on specific sexual attitudes and practices and various forms of sexual stimulation will be provided. Mental health screening will also be conducted at this session.Session 4: Referral for comprehensive treatment: After a careful evaluation of the patient's performance during the previous meetings, the patient will be referred if it was concluded that she requires more specialist psychosexual counselling in areas such as male sexual dysfunctions and psychological disorders.Patients will be asked to fill the questionnaires after the intervention completion and also three months after the final counselling session. Intervention 2: Control group: First, patients are asked to complete the questionnaire. Patients in this group will receive the current standard treatment for Mastalgia. The investigator will not provide the routine treatment. After completing counselling sessions for the intervention group, the control group will be asked to complete the questionnaire simultaneously.If the PLISSIT method outperforms the current standard treatment, after finishing the study, for ethical considerations, patients in the control group will also be introduced to the psychosexual counselling sessions by the investigator. Yes - There is a plan to make this available What will be shared: All data from questionnaires is able to be shared (without the names of the samples). When: Six months after the publication of the results in the official journals To whom: All researchers working in educational and industrial institutions can apply for it. Conditions: If our documentation prevents repetition of a similar study. If our documentation makes progress in a research process. Where to obtain: The main implementer of the project: Fatemeh Ghodsi Address: unit 27, Ofogh 8 Building, 10th alley, Ferdowsi Avenue, Sadoghi Avenue Tell:00989338678004 email: F.ghodsi@qums.ac.ir , fatimaghodsi@gmail.com How to obtain: It is necessary for the applicant to provide a complete introduction of his or her identity and to explain clearly why his request is necessary. After consultation with other administrators, in particular the supervisor, the requested files will be sent. Comments:
public Fatemeh Ghodsi
unit 27, Ofogh 8 Building, 10th alley, Ferdowsi Avenue, Sadoghi Avenue
Qom Iran (Islamic Republic of) 3716888976 +98 25 3293 5402 F.ghodsi@qums.ac.ir Qazvin University of Medical Sciences scientific Fatemeh Ghodsi
unit 27, Ofogh 8 Building, 10th alley, Ferdowsi Avenue, Sadoghi Avenue
Qom Iran (Islamic Republic of) 3716888976 +98 25 3293 5402 F.ghodsi@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Breast pain of four or above based on the visual analogue scale pain which lasts more than five days according to the Cardiff Breast Clinic. At least 20 years old Having regular menstrual periods Being Married and having regular sex No menopause 20 years 55 years Female pregnancy Lactation Having physical or mental illness (self-declaration) Family or personal history of breast cancer Drug Administration for treating breast pain in the last three months Using hormonal methods for contraception N64.4 Mastodynia Rehabilitation Rehabilitation Intervention group: First, questionnaires will be completed by patients. This then will be followed by four one to one in-person counselling sessions. Sessions take place on a weekly basis and each lasts for 90 minutes. According to the PLISSIT model, sessions are summarised as follows: Session 1: Patient administration. During this session, the history of breast pain and sexual discomforts of the patient will be recorded.Session 2: Patient will receive a brief anatomical and physiological summary of limbs and breast.Session 3: Explicit recommendations. At this session, consultation on specific concerns such as fundamental sexual related concepts and training on specific sexual attitudes and practices and various forms of sexual stimulation will be provided. Mental health screening will also be conducted at this session.Session 4: Referral for comprehensive treatment: After a careful evaluation of the patient's performance during the previous meetings, the patient will be referred if it was concluded that she requires more specialist psychosexual counselling in areas such as male sexual dysfunctions and psychological disorders.Patients will be asked to fill the questionnaires after the intervention completion and also three months after the final counselling session. Control group: First, patients are asked to complete the questionnaire. Patients in this group will receive the current standard treatment for Mastalgia. The investigator will not provide the routine treatment. After completing counselling sessions for the intervention group, the control group will be asked to complete the questionnaire simultaneously.If the PLISSIT method outperforms the current standard treatment, after finishing the study, for ethical considerations, patients in the control group will also be introduced to the psychosexual counselling sessions by the investigator. Sexual satisfaction. Timepoint: Before the intervention - one month after the intervention - three months after the intervention. Method of measurement: Larson Sexual Satisfaction Questionnaire. Sex Distress. Timepoint: Before the intervention- one month after the intervention - three months after the intervention. Method of measurement: Sexual Distress Dissolved Questionnaire. Qazvin University of Medical Sciences Approved 2018-09-25 Ethics committee of qazvin University of Medical Sciences Shahid Bahonar Blvd Qazvin Qazvin Iran (Islamic Republic of)