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IRCT20240520061847N1 IRCT 2024-08-21 Qazvin University of Medical Sciences Investigating the effect of mindfulness based cognitive therapy on sexual satisfaction and distress of married women with cyclic mastalgia MBCT Investigating the effect of mindfulness based cognitive therapy on sexual satisfaction and distress of married women with cyclic mastalgia 2024-09-22 anticipated 72 Complete https://irct.ir/trial/78409 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: For random allocation, four block method will be used. In order to determine the sequence of allocation by the four block method, random allocation sequence generation software will be used. The quadruple block method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization ensures that there is no significant imbalance between groups at any time during randomization and that at any given point the number of participants in each group is equal. By using the balanced block randomization method (block randomization balanced) with blocks of four, they will be placed in two test and control groups. By choosing 18 quadruple blocks, people will be randomly assigned to test and control groups. Hiding the allocation sequence: In order to hide the allocation sequence, the papers specifying the group of people will be placed in white envelopes and coded in the same order. Then, a questionnaire with the same code will be completed for the person who will be in the intervention group. N/A Condition 1: Cyclic mastalgia. Condition 2: sexual satisfaction. Condition 3: sexual distress. Intervention 1: Intervention group: Cognitive therapy based on mindfulness will be planned in the form of eight approximately two-hour sessions and will be held virtually twice a week.How to present the intervention: The first session of this consultation will be in person at the comprehensive health centers of Qazvin city to introduce and explain the objectives of the study as well as explanations about periodic breast pain. Other meetings will be held individually through virtual networks (ITA, Telegram, WhatsApp) that are available to the participants. For this purpose, the time of each of the online meetings will be determined in advance based on the convenience of the participant. On the designated date, the participant and the researcher will be online at the same time. The researcher will first present the desired content to the participant in each session, and the possibility of interaction between the participant and the researcher will be provided for question and answer and to ensure the correct understanding of the presented content. These meetings will be online, which leads to two-way communication between the consultant and the participant, and people can easily talk about their problems and get the answers they need from the consultant. Educational content will be provided to the participants in the form of audio and text files along with online counseling. Intervention 2: Control group: The control group will also receive routine care and no intervention will be done for them. At the end of the study, the prepared files will be provided to them, and if necessary, a counseling session will be held for them. Yes - There is a plan to make this available What will be shared: Only part of the data is shared When: 5 months To whom: researchers Conditions: Research design Where to obtain: Elnaz Abedi, elnazabedi13780@gmail.com, postal code: 3419759811 How to obtain: Email submission process: elnazabedi13780@gmail.com Comments:
public Elnaz Abedi
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
Qazvin Iran (Islamic Republic of) 34197-59811 +98 28 3366 1768 elnazabedi13780@gmail.com Qazvin University of Medical Sciences scientific Elnaz Abedi
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
Qazvin Iran (Islamic Republic of) 34197-59811 +98 28 3366 1768 elnazabedi13780@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Having breast pain for more than 5 days per month according to the Cardiff breast pain table and pain intensity greater than 4 in every 5 days according to the objective pain ruler . Married women Age range of 20 years to before menopause Having regular menstrual periods Willingness to participate in the study 20 years 55 years Female Having marital conflicts based on the person's statement Pregnancy Breastfeeding Suffering from physical and mental illnesses (self-reported) Personal or family history of breast cancer receiving medical treatment to reduce breast pain in the last three months Using hormonal methods to prevent pregnancy History of surgery or breast sampling N64.4 Mastodynia Treatment - Other N/A Intervention group: Cognitive therapy based on mindfulness will be planned in the form of eight approximately two-hour sessions and will be held virtually twice a week.How to present the intervention: The first session of this consultation will be in person at the comprehensive health centers of Qazvin city to introduce and explain the objectives of the study as well as explanations about periodic breast pain. Other meetings will be held individually through virtual networks (ITA, Telegram, WhatsApp) that are available to the participants. For this purpose, the time of each of the online meetings will be determined in advance based on the convenience of the participant. On the designated date, the participant and the researcher will be online at the same time. The researcher will first present the desired content to the participant in each session, and the possibility of interaction between the participant and the researcher will be provided for question and answer and to ensure the correct understanding of the presented content. These meetings will be online, which leads to two-way communication between the consultant and the participant, and people can easily talk about their problems and get the answers they need from the consultant. Educational content will be provided to the participants in the form of audio and text files along with online counseling. Control group: The control group will also receive routine care and no intervention will be done for them. At the end of the study, the prepared files will be provided to them, and if necessary, a counseling session will be held for them. Sexual satisfaction score in the Sexual Satisfaction Scale for Women. Timepoint: Measurement of sexual satisfaction at the beginning of the study (before the intervention) and in the follow-ups one and three months after the intervention. Method of measurement: The Sexual Satisfaction Scale for Women. Sexual distress score in the Sexual Satisfaction Scale for Women. Timepoint: Measurement of sexual distress at the beginning of the study (before the intervention) and in the follow-ups one and three months after the intervention. Method of measurement: The Sexual Satisfaction Scale for Women. Mindfulness score in The Five Facet Mindfulness Questionnaire. Timepoint: Measurement of mindfulness at the beginning of the study (before the intervention) and in the follow-ups one and three months after the intervention. Method of measurement: The Five Facet Mindfulness Questionnaire. The intensity of breast pain according to the score of Visual analog scale. Timepoint: At the beginning of the study (before the start of the intervention) and in the follow-ups 1 and 3 months after the intervention. Method of measurement: Visual analog scale. Qazvin University of Medical Sciences Approved 2024-08-07 Ethics committee of Qazvin University of Medical Sciences Qazvin University of Medical Sciences, Shahid Bahonar Boulevard Qazvin Qazvin Iran (Islamic Republic of)