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IRCT20161126031117N12 IRCT 2022-05-04 Mazandaran University of Medical Sciences Evaluation of the effectiveness of hypnotherapy on polycystic ovary syndrome The comparison of hypnotherapy and routine care on the resilience of women with polycystic ovary syndrome 2022-03-25 anticipated 56 Complete https://irct.ir/trial/62236 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Blinding will be done at the assessor level. In this way, after finishing the work, The colleague hands over the questionnaires to the samples and after completing the questionnaire by them, a box will be placed there and the samples will insert the completed questionnaire in the box and groups are named A and B. The statistical analyst is also blinded and at the end of the analysis, the coded groups are identified, Randomization description: In this study, random blocking method will be used for random allocation of samples in the intervention and control groups, based on marital status (single and married) and BMI (<20, 20-25 and> 25). For this purpose, double blocks will be considered. The two possible blocks are TC and CT, that T stands for the intervention group and C stands for the control group. Numbers will be generated randomly (with the RANDBETWEEN command in Excel software and in ranges 1 and 2) and according to the production values ​​of one of the blocks (for production number 1 CT block, for production number 2 TC blocks) will be selected and samples will be allocated. For example, two married people with a body mass index of 20-25 have been referred, one to be included in the intervention group and the other one in the control group. In Excel software, between number one and two, assuming the number two is selected randomly. Therefore, these two people are assigned to the TC block. Accordingly, these two people are assigned to refer to this block in order. In fact, the first person enters the intervention group and the second person enters the control group. Now, if the number one is chosen, these two people will be assigned to the CT block. 3 polycystic ovarian syndrome. Intervention 1: Intervention group: In the intervention group, hypnotherapy is performed by a trained researcher who is trained in the Iranian Association of Clinical Hypnosis and has a valid certificate. For each subject in the intervention group, 6 weekly sessions of hypnotherapy will be held for 40 to 60 minutes. 1. During the first session, the biography, a full explanation of how to do the work and educating and preparing the patient, eliminating the misunderstanding of hypnosis and completing the questionnaire will be done. Patients are also asked to describe a place in the real world that gives them a sense of safety and comfort. 2. In the second session, induction and deepening and direct instincts to increase relaxation and conditioning for rapid hypnosis will be done. 3.In the third session, the ego will be strengthened to increase self-esteem and increase the endurance and resilience of life issues by the individual. 4.During the fourth session, age regression and dealing with negative emotions and then increasing calmness will be done. 6.In the sixth session, the previous sessions will be reviewed and then the mental experience of ideal body image and focusing on increasing relaxation in the whole body and mind will be done. Then the questionnaires are completed again. Intervention 2: Control group: For the control group routine care will be done (Routine care means receiving standard treatments by a gynecologist and balanced physical activity and diet). Questionnaires will be completed simultaneously with the intervention group at all stages. Yes - There is a plan to make this available What will be shared: Research-related information is shared with the aim of keeping individuals' names and identities confidential and adhering to the 31 Code of Ethics. When: from 2023 To whom: All researchers and research enthusiasts Conditions: For reviewing and supplementary research and in order to use by therapists of polycystic ovarian syndrome Where to obtain: To access data and documents, you can contact to the responsible author whose e-mail is: khanisog343@gmail.com and the e-mail of the midwifery student which is mw.mahtabhmr@gmail.com. If the article is published, you can refer to it according to the address of the magazine. How to obtain: they should first send an email to the author of the article and submit their request, and if the author and the research team deem it appropriate, the documents and files will be provided in a short time. Comments:
public Mahtab Hajimohammadreza
Shahid Rajaee street
Tehran Iran (Islamic Republic of) 1884913628 +98 21 5593 6961 mw.mahtabhmr@gmail.com Mazandaran University of Medical Sciences scientific Dr. Soghra khani
Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran Sari Mazandaran
Sari Iran (Islamic Republic of) 4817918479 +98 11 3336 7342 s.khani@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) single or married women with confirmed polycystic ovarian syndrome according to Rotterdam criteria Have come to visit for the first time because of this disease being able to read and write or speak in Persian have Iranian nationality being satisfied to participate in the research 18 years 45 years Female Occurrence of any kind of acute complication affecting the quality of life and resilience during the intervention, such as the death of important people in a person's life. being suffering from other endocrine diseases or any other chronic diseases which affect patient`s quality of life such as Chronic debilitating liver and kidney disease being psychotic and having serious thoughts of harm to oneself and others (recognized by a psychiatrist) being Infertile and undergoing assisted reproductive therapy history of seizures using psychotropic drugs and any kind of drug abuse participating in similar training sessions E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Intervention group: In the intervention group, hypnotherapy is performed by a trained researcher who is trained in the Iranian Association of Clinical Hypnosis and has a valid certificate. For each subject in the intervention group, 6 weekly sessions of hypnotherapy will be held for 40 to 60 minutes. 1. During the first session, the biography, a full explanation of how to do the work and educating and preparing the patient, eliminating the misunderstanding of hypnosis and completing the questionnaire will be done. Patients are also asked to describe a place in the real world that gives them a sense of safety and comfort. 2. In the second session, induction and deepening and direct instincts to increase relaxation and conditioning for rapid hypnosis will be done. 3.In the third session, the ego will be strengthened to increase self-esteem and increase the endurance and resilience of life issues by the individual. 4.During the fourth session, age regression and dealing with negative emotions and then increasing calmness will be done. 6.In the sixth session, the previous sessions will be reviewed and then the mental experience of ideal body image and focusing on increasing relaxation in the whole body and mind will be done. Then the questionnaires are completed again. Control group: For the control group routine care will be done (Routine care means receiving standard treatments by a gynecologist and balanced physical activity and diet). Questionnaires will be completed simultaneously with the intervention group at all stages. Resilience. Timepoint: before intervention, 6 weeks after starting the intervention, 4 weeks after ending the intervention. Method of measurement: Connor-Davidson Resilience Scale. Quality of life. Timepoint: before intervention, 6 weeks after starting the intervention, 4 weeks after ending the intervention. Method of measurement: PCOS Health-Related Quality of Life Questionnaire. Anxiety and depression. Timepoint: before intervention, 6 weeks after starting the intervention, 4 weeks after ending the intervention. Method of measurement: Hospital Anxiety and Depression Scale. Mazandaran University of Medical Sciences Approved 2022-04-13 Ethics committee of Mazandaran University of Medical Sciences Moalem square, Moalem street sari Mazandaran Iran (Islamic Republic of)