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IRCT20220413054530N1 IRCT 2022-05-02 Gonabad University of Medical Sciences The effect of ear acupressure on diabetes The effect of ear acupressure in comparison with sham control on neuropathy symptoms and quality of life in patients with type 2 diabetes 2022-05-10 anticipated 70 Complete https://irct.ir/trial/62955 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, patients with diabetes referred to a special clinic in Boshrouyeh, affiliated to Birjand University of Medical Sciences, will be selected by an accessible and purposeful method based on inclusion criteria and then randomly divided into four groups of intervention and control by blocks of size 4. In this way, a list of 6 expected blocks (AABB, ABAB, BABA, ABBA, BAAB, BBAA) has been prepared and by assigning a number to each block (from 1 to 6) by throwing the dice, the blocks are randomly selected and the necessary allocation is made. This process will continue until the sample size is completed. (A for the experimental group and B for the control group), Blinding description: In this study, participants will be randomly assigned to one of two control or test groups and will be unaware of which group they are in. For blinding in the control group, ear acupressure labels similar to the experimental group will be used, with the difference that in the control group, these labels will be used in places that will not have an effect on improving patients' neuropathy. N/A Diabetic neuropathy. Intervention 1: Intervention group: For patients in this group, in addition to the patient's routine medical care for acupressure, pressure is applied to the labels containing 5 plant seeds (which are used to form labels and the type of plant used has no effect on acupressure) located in the adaptive area of the legs in the ear. The external will be used for 1 minute (the pressure will be to the extent that the patient feels it but does not cause pain and discomfort) 3 times a day (every 8 hours) for 6 weeks by the patient after training. Intervention 2: Control group: In this group, in addition to the patient's routine medical care, pressure is applied to the labels containing 5 plant seeds located in the adaptive area of the heart (which has no effect on patients' neuropathy) in the outer ear for 1 minute, which is 3 times. It is performed around the clock (every 8 hours) for 6 weeks by the patient himself after training. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Ali mohammad ali nia
No. 43; Farhangian building; behind Hazrat Khadijeh Mosque; Varzesh Boulevard
Boshruoyeh Iran (Islamic Republic of) 9781683641 +98 56 3278 1142 a.mohammadnia69@gmail.com Gonabad University of Medical Sciences scientific Ali Mohammd Ali nia
No. 43; Farhangian building; behind Hazrat Khadijeh Mosque; Varzesh Boulevard
boshrouyeh Iran (Islamic Republic of) 9781683641 +98 56 3278 1142 a.mohammadnia69@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Patient willingness and having written informed consent to participate in the study Get a minimum score of 6 on the Toronto Diabetic Neuropathy Questionnaire Awareness and ability to speak and communicate to report the severity of clinical symptoms during the examination Age between 18 to 60 years Having a natural earlobe 18 years 60 years Both History of disease or condition affecting neuropathy based on medical history and patient report The presence of any known complication and other medical problem leads to pain Existence of a lesion or skin problem in the area of the ear and the site of acupressure G99.0 Autonomic neuropathy in diseases classified elsewhere Other Placebo Intervention group: For patients in this group, in addition to the patient's routine medical care for acupressure, pressure is applied to the labels containing 5 plant seeds (which are used to form labels and the type of plant used has no effect on acupressure) located in the adaptive area of the legs in the ear. The external will be used for 1 minute (the pressure will be to the extent that the patient feels it but does not cause pain and discomfort) 3 times a day (every 8 hours) for 6 weeks by the patient after training. Control group: In this group, in addition to the patient's routine medical care, pressure is applied to the labels containing 5 plant seeds located in the adaptive area of the heart (which has no effect on patients' neuropathy) in the outer ear for 1 minute, which is 3 times. It is performed around the clock (every 8 hours) for 6 weeks by the patient himself after training. Symptoms of neuropathy include pain and sensory disturbances (including burning, numbness, tingling, weakness, muscle cramps). Timepoint: Beginning of the study (before the intervention) and after the intervention (six weeks after the intervention). Method of measurement: Neuropathy Symptom Score. Quality of life. Timepoint: At the beginning of the study (before the intervention) and six weeks after the start of the study. Method of measurement: Neuropathy specific quality of life. Gonabad University of Medical Sciences Approved 2022-04-11 Ethics Committee of Gonabad University of Medical Sciences Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Asian Roadside, Gonabad - Khorasan Razavi Gonabad Razavi Khorasan Iran (Islamic Republic of)