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IRCT20181207041873N1 IRCT 2019-02-24 Iran University of Medical Sciences Effect of Auriculotherapy a on Primary Dysmenorrhea Severity and Systemic Symptoms associated with it Comprasion of the Effect of Auriculotherapy and Mefenamic Acid on Primary Dysmenorrhea Severity and Systemic Symptoms associated with it in students 2019-03-01 anticipated 90 Complete https://irct.ir/trial/35967 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A researcher at a recall in Qom University of Medical Sciences, after his introduction, explains the sufficient information about the research, including the title of research, the goals of the study, the criteria for entering and leaving the study, the manner and manner of conducting the study for students. Individuals who wish to participate in research with primary dysmenorrhea and inclusion criteria are referred to the researcher by telephone for their research, and are included in the continuous sampling method. The research units are then assigned to the two groups of Auricolotherapy and Mefenamic acid by randomization. In a block random method, quadrilateral blocks are created, in which randomly, half of each block is placed in one group and the other half in the other group. In this study, we want to identify 90 people in two groups of 45 patients with Auricolotherapy and Mefenamic acid, first we identify all four-state states in which half of the people are assigned in the Auricolotherapy group and the other half in the Mefenamic acid group. Then, to each of these four-state combinations that include six modes, we assign one of the digits 1-6. Then we select 25 randomly random numbers from 1 to 6, and we write the combinations of it in succession, and the subjects enter into two groups. N/A Primary Dysmenorrhea and Systemic Symptoms associated with it. Intervention 1: Intervention group: In the auriculotherapy group, it was explained to each person that auriculotherapy is started once every 6 days for 2 cycles of menstruation for each person, and the intervention begins at the end of a menstrual period and continues until the end of the menstrual period. . Totally, for women with different menstrual cycles, the ariculotherapy was performed from at least 2-3 to a maximum of 3 to 4 sessions per cycle each intervention cycle. This practice was carried out by a trained researcher with a degree in auriculotherapy, in a private environment that was designed for this purpose. At the last session of near-menstrual at 4 drops, both ears of herbs were inserted into the ear and explained to people that initiating the onset of the syndrome initially began the onset of menstrual pain, and each point for 1 minute 6 to 4 times a day Press at intervals of at least 1 hour and continue pressing the dots until the end of the menstrual period, and then remove the acne from the pain for 24 hours after relieving pain. Seed in place could stay for 7 days. To avoid forgetting, squeezing the syndas was reminded by telephone and through the virtual group. The strength of the seizures should be such as to cause pain and burning in the outer ear. They were also informed that various feelings might be felt by the pressure of the blood vessels, such as numbness, swelling, mild pain, or heat. People were told that the cheeks were not easily removed and their adhesives relative to body oil They do not react and can not be easily removed from the ear. In the case of going to the bath, the ears should only be washed with water, and until the drying of the ears, do not touch the syringes and inform the researcher if Seyed is detached. To remove the worms, it is best for the patient to put his ears down (ground) The 11 points used to relieve dysmenorrhea were used: the main points of my gravel, thalamic, ziro point and endocrine point, and the anatomical points of the uterus, genitals, ovaries, and the supporting regions of the kidneys, pelvis, vagus, and The prostaglandin is the point. Electric stimulation of the ear after ear disinfection with 70% alcohol and 1 minute of general massage of the ear for relaxation, through the skin at points with a 2-point pointer machine, with a frequency of 2 Hz and a current of 4-2 mA for 20 seconds. Each point was applied by the researcher. At the end of the closing session, the next menstrual period was placed at 4 points in my gravel, thalamic, uterus, and pelvic seated. Intervention 2: Control group: In the mefenamic acid group, people were told to use a 250 mg mefenamic acid capsule during the two menstrual cycles to make the Amin Pharmaceuticals company with the first symptom of menstrual start, such as cramp, pain or bleeding. How to use it was that the first time 2 capsules and then every 6 hours to take a capsule and continue until pain relief. The study units were told to follow this intervention for both menstruation cycles. Yes - There is a plan to make this available What will be shared: Only part of the information, such as information on the main outcome or the like, can be shared When: Start the access period 6 months after publishing the results To whom: Data for researchers and people who are engaged in treatment can apply for them Conditions: Data for researchers and people who are engaged in treatment can apply for them Where to obtain: by Email m.vahedi_89@yahoo.com How to obtain: by Email m.vahedi_89@yahoo.com Comments: 6 months after publishing the results
public Masoomeh Vahedi
No, 98, 1 Aly. Sadogh Ave, Qom Town
Qom Iran (Islamic Republic of) 3716647859 +98 25 3290 1223 m.vahedi_89@yahoo.com Iran University of Medical Sciences scientific Seyede Batool Hasanpoor-Azghady
No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing & Midwifery., Tehran Town,
Tehran Iran (Islamic Republic of) 1907755551 +98 21 2286 0021 hasanpoor.sb@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Being single Iranian nationality Age of 35-18 years Having regular menstrual periods (length of 3-7 days and the interval between two menstrual periods 32-32 days) in the last two cycles Having primary dysmenorrhea with rejection of secondary dysmenorrhea with the diagnosis of a specialist Having menstrual pain as a colic or crampy pain in the suprapubic line, sometimes spreading to the lower back and groin that begins with menstruation and lasts for 2-3 days Primary dysmenorrhea with degrees 2 and 3 according to verbal multi-dimensional criteria Experience primary dysmenorrhea in most menstrual cycles External ear on both sides without lumps, swelling, infection or ulcers in the group of Auriculotherapy 18 years 35 years Female Lack of any known chronic disease and absence of a pacemaker No history of anemia, weakness Non-use of contraceptive pills over the past three months Failure to lose weight during the study Not having a regular exercise activity during the 3 months before the start of the study Lack of body mass index of more than 30 kg per square meter Not having a history of pelvic inflammatory diseases, endometriosis, myoma, and pelvic tumors with the diagnosis of a doctor Non-use of tobacco (cigarettes, hookahs and narcotics) and alcohol No history of any abdominal and pelvic surgery or abnormal ultrasound of the uterus Non-occurrence of severe psychological stress in the last 6 months, such as parental separation, death of first degree relatives and surgical procedures Having no history of mood disorders with expert diagnosis No history of treatment with Auriculotherapy in the last 6 months Treatment - Other Treatment - Drugs Intervention group: In the auriculotherapy group, it was explained to each person that auriculotherapy is started once every 6 days for 2 cycles of menstruation for each person, and the intervention begins at the end of a menstrual period and continues until the end of the menstrual period. . Totally, for women with different menstrual cycles, the ariculotherapy was performed from at least 2-3 to a maximum of 3 to 4 sessions per cycle each intervention cycle. This practice was carried out by a trained researcher with a degree in auriculotherapy, in a private environment that was designed for this purpose. At the last session of near-menstrual at 4 drops, both ears of herbs were inserted into the ear and explained to people that initiating the onset of the syndrome initially began the onset of menstrual pain, and each point for 1 minute 6 to 4 times a day Press at intervals of at least 1 hour and continue pressing the dots until the end of the menstrual period, and then remove the acne from the pain for 24 hours after relieving pain. Seed in place could stay for 7 days. To avoid forgetting, squeezing the syndas was reminded by telephone and through the virtual group. The strength of the seizures should be such as to cause pain and burning in the outer ear. They were also informed that various feelings might be felt by the pressure of the blood vessels, such as numbness, swelling, mild pain, or heat. People were told that the cheeks were not easily removed and their adhesives relative to body oil They do not react and can not be easily removed from the ear. In the case of going to the bath, the ears should only be washed with water, and until the drying of the ears, do not touch the syringes and inform the researcher if Seyed is detached. To remove the worms, it is best for the patient to put his ears down (ground) The 11 points used to relieve dysmenorrhea were used: the main points of my gravel, thalamic, ziro point and endocrine point, and the anatomical points of the uterus, genitals, ovaries, and the supporting regions of the kidneys, pelvis, vagus, and The prostaglandin is the point. Electric stimulation of the ear after ear disinfection with 70% alcohol and 1 minute of general massage of the ear for relaxation, through the skin at points with a 2-point pointer machine, with a frequency of 2 Hz and a current of 4-2 mA for 20 seconds. Each point was applied by the researcher. At the end of the closing session, the next menstrual period was placed at 4 points in my gravel, thalamic, uterus, and pelvic seated. Control group: In the mefenamic acid group, people were told to use a 250 mg mefenamic acid capsule during the two menstrual cycles to make the Amin Pharmaceuticals company with the first symptom of menstrual start, such as cramp, pain or bleeding. How to use it was that the first time 2 capsules and then every 6 hours to take a capsule and continue until pain relief. The study units were told to follow this intervention for both menstruation cycles. Severity of primary dysmenorrhea. Timepoint: Measurement in three cycles of menstruation including basal cycle, first and second cycle of menstruation in intervention. Method of measurement: Visual Analogue Scale. General symptoms associated with dysmenorrhea. Timepoint: Measurement in three cycles of menstruation including basal cycle, first and second cycle of menstruation in intervention. Method of measurement: Verbal Multidimensional Scoring system. Iran University of Medical Sciences Approved 2018-09-29 Ethics Committees of Iran University of Medical Sciences Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)