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IRCT20170611034452N13 IRCT 2021-11-05 Kerman University of Medical Sciences Comparison between Effectiveness of Dry Cupping and Counselling on Fertility Quality of Life and Pregnancy Rate in Infertile Women due to Polycystic Ovarian Syndrome Comparison between Effectiveness of Dry Cupping and Counselling with Mindfulness-based Cognitive Therapy Approach (MBCT) on Fertility Quality of Life and Conception Success in Infertile Women due to Polycystic Ovarian Syndrome: a randomized pilot clinical trial 2021-11-06 anticipated 20 Complete https://irct.ir/trial/55048 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible patients were selected by the Convenience sampling method and continued until reaching the desired sample size (at least 9 people in each group). Using random allocation software version 1, patients with the permutation blocks method (including 5 blocks of four) were randomly allocated to two intervention groups including a counselling and cupping group. Dark-coloured envelopes were also used for allocation concealment. N/A infertile women due to poly cystic ovary syndrome. Intervention 1: Intervention group1:In dry cupping group, treatment session were conducted twice a week during cleansing period for two months by a traditional medicine specialist. Three glass cups were used and selection of their sizes according to the size of the individual. The person was placed on the bed lying on her back so the area of cupping was exposed. The placement of cups was greased with chamomile oil. The first cup was placed on the top of the symphysis pubis. two other cups were placed on the right and left sides of the first one at a distance of 2.5 centimeters. the amount of suction created was such that the skin of the area was sucked to the top of the cup and became red and profuse. the cups were placed according to the patient's tolerance for up to 20 minutes, then they were slowly removed. Intervention 2: Intervention group2: Counseling group with Mindfulness-Based Cognitive Therapy approach (MBCT):In this group, eight sessions held for 90 minutes with 45 minutes a day of exercise, which can be accompanied by a one-day mind-guided program in 6th week. In the first 4 sessions, the focus is on inner experiences and in the second half is on life challenges. All sessions begin with a formal exercise (body checking, mindfulness movement, or sitting meditation practice).Short mindfulness exercises, such as three-minute breathing and conscious walking, are poems and stories related to the topic of the session, and there will also be a short mindfulness exercise at the end of each session. Due to prevalence of Covid19 , counseling sessions held on-line. The summary of counseling protocol with mindfulness-based cognitive therapy approach to increase pregnancy rate in patients with polycystic ovary syndrome is as follows: session1: Mind autopilot: basic acquaintance, stating the purpose of group formation, stating the rules and restrictions of the sessions / defining research variables, raisin technique / body meditation. Homework: 45 minute body meditation, and mindfulness on a daily task And a meal. session2: Overcoming Obstacles: Body Check Meditation, Ten Minutes of Mindful Breathing, Mindfulness Techniques on Thoughts and Feelings Homework: 45-Minute Body Check Meditation, Ten Minutes of Mindful Breathing, and Mindfulness of Another Daily Task, Daily Record of One Experience Pleasant event.session3:Mindfulness of breathing and body while moving: Conscious movement technique, conscious seeing and hearing practice, then stretching and breathing practice and then sitting meditation with body and breathing awareness, three-minute breathing space technique Explore the calendar of pleasant experiences (from week 4) Then it can be accompanied by a calendar of unpleasant experiences.) Homework: Practice stretching and breathing on the first, third and fifth days, practice mindful movement on the second, fourth and sixth days, record an unpleasant event, three-minute breathing space technique Times a day.session4: Session 4: Staying in the present: 5 minutes mind awareness of seeing or hearing, sitting meditation (awareness of breathing, body, sounds, thoughts and consciousness without choice), three-minute breathing space technique and using it when a coping skill when you feel like life is going hard, conscious walking, exploring the calendar of unpleasant experiences with defining the realm of stress Homework: sitting meditation, three-minute breathing space technique with regard to it as a coping skill In any unpleasant feeling.session5: Acceptance and permission. Sitting meditation with awareness on breathing and body, emphasizing how we react to thoughts, feelings, five senses when they occur, introducing problems in mindfulness exercises and exploring its effects on body and mind, three-minute breathing space , Reading a mindfulness-based poem and exploring its themes in the group, exploring habitual patterns of reaction and the potential to use mindfulness skills to facilitate more responsiveness to the experience of the present and the moment of homework: a three-minute breathing space technique with consideration Take it as a coping skill in any unpleasant feeling) and then explore the choice of opening the body gate. session6:Thoughts are not reality: sitting meditation with awareness on breathing and body along with introducing problems in mindfulness exercises and exploring its effects on body and mind, three-minute breathing space, practicing moods, alternative thoughts and perspectives, starting to develop an action plan and Individual validation of mindfulness on home stress-solving: forty-minute exercises a day, working with different combinations of the three main bases of exercises; Use short exercises, exercises with or without CDs, three-minute breathing space (regular three times a day), three-minute breathing space (adaptation during each unpleasant event) and in the first stage, creating a wider view of thoughts, practice Open in thinking, reflection and more work on preventing stress recurrence, action plan.session7:How can I best take care of myself? Sitting meditation with awareness on breathing and body, sounds, thoughts and feelings, three-minute breathing space of the body with the introduction of problems in mindfulness exercises and exploring its effects on body and mind, exploring the relationship between behavior and mood, preparing a list of activities Daily and check which activity creates a feeling of emptiness and which a feeling of strengthening and vitality and dominance. Efforts to increase strengthening activities. Identify signs of recurrence of stress symptoms to deal with possible recurrence. Homework: Perform one of the activities that the person can continue after the sessions. Breathing-Regular and Coping Space: After practicing exploring the choice of opening in skillful performance, consider and create a warning system to detect the recurrence of stress as well as an action plan in times when mood swings. session8: Apply the fact learned in the face of the future: Examining body care, final care, reviewing early warning systems and planning for use at times of high recurrence, reviewing the entire course - the most valuable things in your life that mindfulness exercises do to you in times of encounter Help them continue with the formal and informal exercises they have learned in life .Homework: Plan to continue the exercises in the follow-up period. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Atefeh Ahmadi
Kerman, Haft Bagh Alavi
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5205 a.ahmadi@kmu.ac.ir Kerman University of Medical Sciences scientific Atefeh Ahmadi
Kerman, Haft Bagh Alavi
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5205 a.ahmadi@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Married women with infertility with definitive diagnosis of polycystic ovary syndrome based on Rotterdam criteria by gynecologists Lack of known mental illnesses under treatment Do not use psychotropic drugs and narcotics Married women Ability to read, write and speak Persian Do not attend counseling sessions or medication for fertility Couples agree to have vaginal sex (for example, two to three times a week) around the time of ovulation during the time of the study No endometrial cancer or cervical cancer The subject should not have a history of deep vein thrombosis or pulmonary embolism 18 years 40 years Female ٍEndocrine, endogenous or any chronic diseases affecting the rate of fertilization Treatment - Other Behavior Intervention group1:In dry cupping group, treatment session were conducted twice a week during cleansing period for two months by a traditional medicine specialist. Three glass cups were used and selection of their sizes according to the size of the individual. The person was placed on the bed lying on her back so the area of cupping was exposed. The placement of cups was greased with chamomile oil. The first cup was placed on the top of the symphysis pubis. two other cups were placed on the right and left sides of the first one at a distance of 2.5 centimeters. the amount of suction created was such that the skin of the area was sucked to the top of the cup and became red and profuse. the cups were placed according to the patient's tolerance for up to 20 minutes, then they were slowly removed. Intervention group2: Counseling group with Mindfulness-Based Cognitive Therapy approach (MBCT):In this group, eight sessions held for 90 minutes with 45 minutes a day of exercise, which can be accompanied by a one-day mind-guided program in 6th week. In the first 4 sessions, the focus is on inner experiences and in the second half is on life challenges. All sessions begin with a formal exercise (body checking, mindfulness movement, or sitting meditation practice).Short mindfulness exercises, such as three-minute breathing and conscious walking, are poems and stories related to the topic of the session, and there will also be a short mindfulness exercise at the end of each session. Due to prevalence of Covid19 , counseling sessions held on-line. The summary of counseling protocol with mindfulness-based cognitive therapy approach to increase pregnancy rate in patients with polycystic ovary syndrome is as follows: session1: Mind autopilot: basic acquaintance, stating the purpose of group formation, stating the rules and restrictions of the sessions / defining research variables, raisin technique / body meditation. Homework: 45 minute body meditation, and mindfulness on a daily task And a meal. session2: Overcoming Obstacles: Body Check Meditation, Ten Minutes of Mindful Breathing, Mindfulness Techniques on Thoughts and Feelings Homework: 45-Minute Body Check Meditation, Ten Minutes of Mindful Breathing, and Mindfulness of Another Daily Task, Daily Record of One Experience Pleasant event.session3:Mindfulness of breathing and body while moving: Conscious movement technique, conscious seeing and hearing practice, then stretching and breathing practice and then sitting meditation with body and breathing awareness, three-minute breathing space technique Explore the calendar of pleasant experiences (from week 4) Then it can be accompanied by a calendar of unpleasant experiences.) Homework: Practice stretching and breathing on the first, third and fifth days, practice mindful movement on the second, fourth and sixth days, record an unpleasant event, three-minute breathing space technique Times a day.session4: Session 4: Staying in the present: 5 minutes mind awareness of seeing or hearing, sitting meditation (awareness of breathing, body, sounds, thoughts and consciousness without choice), three-minute breathing space technique and using it when a coping skill when you feel like life is going hard, conscious walking, exploring the calendar of unpleasant experiences with defining the realm of stress Homework: sitting meditation, three-minute breathing space technique with regard to it as a coping skill In any unpleasant feeling.session5: Acceptance and permission. Sitting meditation with awareness on breathing and body, emphasizing how we react to thoughts, feelings, five senses when they occur, introducing problems in mindfulness exercises and exploring its effects on body and mind, three-minute breathing space , Reading a mindfulness-based poem and exploring its themes in the group, exploring habitual patterns of reaction and the potential to use mindfulness skills to facilitate more responsiveness to the experience of the present and the moment of homework: a three-minute breathing space technique with consideration Take it as a coping skill in any unpleasant feeling) and then explore the choice of opening the body gate. session6:Thoughts are not reality: sitting meditation with awareness on breathing and body along with introducing problems in mindfulness exercises and exploring its effects on body and mind, three-minute breathing space, practicing moods, alternative thoughts and perspectives, starting to develop an action plan and Individual validation of mindfulness on home stress-solving: forty-minute exercises a day, working with different combinations of the three main bases of exercises; Use short exercises, exercises with or without CDs, three-minute breathing space (regular three times a day), three-minute breathing space (adaptation during each unpleasant event) and in the first stage, creating a wider view of thoughts, practice Open in thinking, reflection and more work on preventing stress recurrence, action plan.session7:How can I best take care of myself? Sitting meditation with awareness on breathing and body, sounds, thoughts and feelings, three-minute breathing space of the body with the introduction of problems in mindfulness exercises and exploring its effects on body and mind, exploring the relationship between behavior and mood, preparing a list of activities Daily and check which activity creates a feeling of emptiness and which a feeling of strengthening and vitality and dominance. Efforts to increase strengthening activities. Identify signs of recurrence of stress symptoms to deal with possible recurrence. Homework: Perform one of the activities that the person can continue after the sessions. Breathing-Regular and Coping Space: After practicing exploring the choice of opening in skillful performance, consider and create a warning system to detect the recurrence of stress as well as an action plan in times when mood swings. session8: Apply the fact learned in the face of the future: Examining body care, final care, reviewing early warning systems and planning for use at times of high recurrence, reviewing the entire course - the most valuable things in your life that mindfulness exercises do to you in times of encounter Help them continue with the formal and informal exercises they have learned in life .Homework: Plan to continue the exercises in the follow-up period Fertility Quality of Life. Timepoint: participants completed the FertiQol questionnaire before the intervention and three months after the end of the intervention. Method of measurement: FertiQol questionnaire. Conception success. Timepoint: At four times: immediately after the end of treatment, one month, two months, three months after the end of treatment in case of delay in menstruation. Method of measurement: Quality Beta-HCG by blood sample. Kerman University of Medical Sciences Approved 2021-08-30 Research Ethics Committees of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)