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IRCT20200613047756N1 IRCT 2020-07-19 Ahvaz University of Medical Sciences The effect of auriculotherapy on sleep quality The effect of auriculotherapy on sleep quality in postmenopausal women 2021-01-20 anticipated 41 Complete https://irct.ir/trial/48893 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting the research units, the individuals will be randomly assigned 1: 1 in blocks of 4. In order to hide the allocation, envelopes will be used in the matte package, which are numbered in order and the type of intervention is written inside them.These envelopes will be prepared by the researcher involved in collecting data that is not known from the research, Blinding description: In order to hide the allocation, envelopes will be used in matte packages, which are numbered in order and the type of intervention is written inside them. These envelopes will be prepared by a non-involved researcher in data collection. N/A sleep disorder. Intervention 1: Intervention group: In this experiment, using an Excel 2 AUrycolotherapy device made in China, the main points related to sleep in the right ear are stimulated for 15 seconds, The plantar warts are then attached to the irritated spots of Vakaria, and it is recommended that the person be pressured for one minute every hour except for bedtime and return after 6 days. The duration of the intervention was 4 weeks. Intervention 2: Control group: n this experiment, using an Excel 2 Aurycolotherapy device made in China, the false spots on the back of the right ear are stimulated for 15 seconds.Then, on the irritated areas, the plantar fissures of Vakaria are glued without a nut, and it is recommended that the person press the seedlings for one minute every hour, except for bedtime, and return after 6 days. The intervention period was 4 weeks. Yes - There is a plan to make this available What will be shared: All Study data includes primary and secondary outcomes and other study data after non-identifiable shareable individuals. When: Study data will be available 6 months after the results are published. To whom: Other study documents should be made available to the public. Conditions: Individuals with the name of the study researcher are allowed to use the study documents, individuals are not allowed to analyze any of the submitted data. Where to obtain: To receive the documents, people can contact the following mailing address: m.eidany1363@gmail.com How to obtain: The applicant of these documents will respond to the request within 24 hours after the request is sent via e-mail, and the relevant files will be provided to the applicant. Comments:
public Mona Eidani
North Abuzar Alley 10, Sadat St, Taleghani Town
Mahshahr Iran (Islamic Republic of) 63531-96474 +98 61 5244 0028 m.eidany1363@gmail.com Ahvaz University of Medical Sciences scientific Mona Eidani
North Abuzar Alley 10, Sadat St, Taleghani Town
Mahshar Iran (Islamic Republic of) 63531-96474 +98 61 5244 0028 m.eidany1363@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Amenorrhea for at least 12 months Ages 60-45 Get a score of more than 5 from the Pittsburgh Questionnaire 45 years 60 years Female Having a known underlying disease (heart, kidney, thyroid, hypertension, diabetes, etc.) The emergence of any physical or mental illness during research that causes sleep disorders Use of hormone therapy, Armatase inhibitors, clonidine and antidepressants, sleeping pills during the last three months and during the study Consumption of alcohol and addictive substances and tobacco Severe uterine bleeding Loss of a relative during the last 6 months and during the study Use of other traditional therapies and complementary medicine in the last 4 weeks during the study Emergence of significant change in unpredictable sleep conditions, including travel, relocation Take any herbal or chemical sleeping pills Having edema and inflammation in both ears G47 G47.0 VI Diseases of the nervous system , Sleep disorders , Disorders of initiating and maintaining sleep [insomnias], Disorders of excessive somnolence [hypersomnias] Disorders of the sleep-wake schedule. Sleep apnoea ,Narcolepsy and cataplexy , Other sleep Treatment - Devices Treatment - Devices Intervention group: In this experiment, using an Excel 2 AUrycolotherapy device made in China, the main points related to sleep in the right ear are stimulated for 15 seconds, The plantar warts are then attached to the irritated spots of Vakaria, and it is recommended that the person be pressured for one minute every hour except for bedtime and return after 6 days. The duration of the intervention was 4 weeks. Control group: n this experiment, using an Excel 2 Aurycolotherapy device made in China, the false spots on the back of the right ear are stimulated for 15 seconds.Then, on the irritated areas, the plantar fissures of Vakaria are glued without a nut, and it is recommended that the person press the seedlings for one minute every hour, except for bedtime, and return after 6 days. The intervention period was 4 weeks. Sleep quality score in the Pittsburgh questionnaire. Timepoint: Completion of the questionnaire then 4 weeks of intervention with the Auriculotherapy device and re-completion of the questionnaire. Method of measurement: Pittsburgh Questionnaire. Sleep Mental Quality Score in the Pittsburgh Questionnaire. Timepoint: Completion of the questionnaire, then 4 weeks of intervention with the Auricotherapy device, then re-completion of the questionnaire. Method of measurement: Pittsburgh Questionnaire. Sleep efficiency score on the Pittsburgh questionnaire. Timepoint: Completion of the questionnaire, then 4 weeks of intervention with the Auricotherapy device, then re-completion of the questionnaire. Method of measurement: Pittsburgh Questionnaire. Daily Performance Disorder Score in the Pittsburgh Questionnaire. Timepoint: Completion of the questionnaire, then 4 weeks of intervention with the Auricotherapy device, then re-completion of the questionnaire. Method of measurement: Pittsburgh Questionnaire. Ahvaz University of Medical Sciences Approved 2020-06-10 Ethics Committee of Ahvaz University of Medical Sciences North Abuzar Ally 10, Sadat St, Taleghani Town Mahshahr Khouzestan Iran (Islamic Republic of)