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IRCT20220203053922N1 IRCT 2022-03-19 Esfahan University of Medical Sciences Comparative study of the effect of hypnotherapy and Monstrogol capsule on primary dysmenorrhea in girls living in dormitories of Isfahan University of Medical Science in 2022 Comparative study of the effect of hypnotherapy and Monstrogol capsule on primary dysmenorrhea 2022-04-04 anticipated 72 Complete https://irct.ir/trial/61977 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, sample selection and random assignment in two groups using Minimization software will be used; In this way, the list of people is entered into the software by coding and people are randomly selected by the software, and are placed in two groups of test and control, Blinding description: This research will be a double-blind clinical trial (because the analyzer and the questioner will be unaware of which group the people are in) and the collection of information and random allocation of samples using Minimization software, so this study, two Group (test and control group) is three-stage and multivariate. The questioner is not aware of the grouping of individuals when recording information and results, and the analyzer is not aware of the grouping of individuals when analyzing data, and individuals are examined by specific codes. 3 Primary dysmenorrhea. Intervention 1: Intervention group: Hypnotherapy. Hypnotherapy will be performed in three sessions of 20 minutes for the experimental group individually.In the first session, hypnotherapy is introduced as a safe and uncomplicated medical treatment and also indoctrination test is performed. At the end of the first session, a light ecstasy and simple relaxation are given to the subjects.In the second session, various techniques are used to enter the trance, and following the involuntary closing of the eyes, inductions related to muscle relaxation and deepening techniques will be performed, and analgesia will begin. In the hypnosis phase, conditioning is done and they learn how to be able to anesthetize their desired areas. In the third session, trance practice and self-hypnotherapy will be performed and more deepening techniques will be used and people will be conditioned to fall into ecstasy when hearing dysmenorrhea by listening to the researcher's instincts and immediately anesthetize their desired points. After these steps, with the onset of dysmenorrhea, the subjects will be able to enter the trance and begin analgesia by listening to the researcher's hypnotherapy. Intervention 2: Control group: Menstrog capsule. Monstrogol (dry extract of saffron stigma, anise and celery) is a herbal capsule that has the effect of reducing menstrual pain and has an effect on smooth muscle contraction and has anti-inflammatory properties. This capsule contains 1/4 mg of dry extract powder of saffron stigma, 1/60 mg of dry extract powder of anise fruit and 1/16 mg of dry extract powder of celery. The amount of drug is 2.8-2.2 microliters of total essential oil and 3.1-1 microliters of anethole in each capsule. People in the control group of Monstrogol drug produced by Gol Daroo Company take one capsule every 8 hours for 3 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of information of the subjects
public Dr. Mahboobeh Valiani
Hezar Jerib st.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 Mahboobehvaliani@gmail.com Esfahan University of Medical Sciences scientific Dr. Mehdi Fathi
Danesh va Salamat Town, between Shahid Javan and Al-Shahidi Squares, Shahid Fakoori Boulevard
Mashhad Iran (Islamic Republic of) 13944-91388 +98 51 3841 2081 mandala_110@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Conscious consent to participate in research Single students living in dormitories Suffering age 25-18 years Having regular menstrual periods Having primary dysmenorrhea for at least two consecutive previous periods No application of complementary medicine methods during the last two months Painful menstruation in most menstrual cycles with a pain score of at least 4 out of 10 according to the Visual Analogue Scale (VAS) during two periodic periods Hypnosis of people no limit no limit Female Any known disease of the genital tract Secondary dysmenorrhea History of abdominal or pelvic surgery Endometriosis Tobacco use (cigarettes, hookah and drugs), alcohol Speech, hearing, and mental problems Heart, kidney, respiratory, diabetes, asthma, hypothyroidism or hyperthyroidism, epilepsy and other patients in need of medication Sudden weight loss Special diet (vegetarian) Do professional exercise and intense physical exercises Use of herbs, traditional and complementary medicine during the last two months Psychological problems and diseases requiring medication (bipolar disorder, psychosis, major depression, obsession, borderline disorders, dependent personality disorder, schizoid personality disorder, paranoid personality disorder) based on self-reported research units Having coagulation disorders and taking anticoagulants Existence of depression in the individual based on the score obtained from the DASS21 questionnaire Treatment - Other Treatment - Drugs Intervention group: Hypnotherapy. Hypnotherapy will be performed in three sessions of 20 minutes for the experimental group individually.In the first session, hypnotherapy is introduced as a safe and uncomplicated medical treatment and also indoctrination test is performed. At the end of the first session, a light ecstasy and simple relaxation are given to the subjects.In the second session, various techniques are used to enter the trance, and following the involuntary closing of the eyes, inductions related to muscle relaxation and deepening techniques will be performed, and analgesia will begin. In the hypnosis phase, conditioning is done and they learn how to be able to anesthetize their desired areas. In the third session, trance practice and self-hypnotherapy will be performed and more deepening techniques will be used and people will be conditioned to fall into ecstasy when hearing dysmenorrhea by listening to the researcher's instincts and immediately anesthetize their desired points. After these steps, with the onset of dysmenorrhea, the subjects will be able to enter the trance and begin analgesia by listening to the researcher's hypnotherapy. Control group: Menstrog capsule. Monstrogol (dry extract of saffron stigma, anise and celery) is a herbal capsule that has the effect of reducing menstrual pain and has an effect on smooth muscle contraction and has anti-inflammatory properties. This capsule contains 1/4 mg of dry extract powder of saffron stigma, 1/60 mg of dry extract powder of anise fruit and 1/16 mg of dry extract powder of celery. The amount of drug is 2.8-2.2 microliters of total essential oil and 3.1-1 microliters of anethole in each capsule. People in the control group of Monstrogol drug produced by Gol Daroo Company take one capsule every 8 hours for 3 days. Pain score. Timepoint: Before. Immediately and two months after the intervention. Method of measurement: Pain ruler. Number of pain days. Timepoint: Before. Immediately and two months after the intervention. Method of measurement: Asking the patient. Bleeding volume. Timepoint: Before. Immediately and two months after the intervention. Method of measurement: PBLAC chart. Esfahan University of Medical Sciences Approved 2022-01-31 Ethics committee of Isfahan University of Medical Sciences 22 plack, No. 4 West, Narvan st, Shahed blvd Shahin Shahr Isfehan Iran (Islamic Republic of)