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IRCT20100211003329N6 IRCT 2021-04-01 Kashan University of Medical Sciences The Effect of Uriculotherapy on Depression in Elderly The Effect of Uriculotherapy on Depression in Elderly 2021-04-21 anticipated 52 Complete https://irct.ir/trial/54943 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: If subjects are satisfied with participating in the study, the selected qualifying samples will be randomly assigned to each of the two groups (intervention and control) in the form of block randomization in the form of 4 and 6 blocks. Using the Sealed Envelope Ltd software. 2017 Available Through www.sealedenvelope.com 4 -4-block and 6 -6-block, overall 10 blocks were defined that the allocation to groups would be based on the order specified by the software, Blinding description: Participants and outcome assessors are unaware of the nature of the seals pasted on participants' ears. N/A depression. Intervention 1: uriculotherapy will be performed twice a day for four weeks, five days a week. In this group, Korean-made Vakaria brand DONG BANG will be glued by a researcher on the points of Shenman, Zero, Hart, Antiperspirant, and Master-Cerebral that are associated with depression. The elderly will be instructed to press these sideways twice a day, 60 times each time with the index finger and thumb, according to the intended schedule. During the 4 weeks of the intervention, the labels will be affixed alternately on both ears by the researcher on a weekly basis. The labels are placed on the ear for five days each week and the elderly are instructed to remove them by the end of the fifth day or by those around them to prevent possible allergic reactions. It is also noted that if the Sides are separated during the five-day period, the researcher should be notified by telephone; In that case, the researcher, with the consent of the elderly person, will re-attach the sheets at his home, in the health center or wherever it is convenient for the elderly person. Each participant will be taught how to press the sidewalls by researcher. In addition, during the intervention, a weekly diary will be provided to the elderly person, in which he / she will specify the number of times each time the pressure and use of the new drug. The contents of the diary are organized using visual symbols in a way that can be understood and completed with simple training by all partcipants, including literate and illiterate. During the intervention period, all participants will be visited at the agreed location each week and new seeds will be affixed to them, and a diary will be delivered to them and another sheet will be delivered to them for the following week. Intervention 2: Control group:During the 4 weeks of the intervention, the labels will be affixed alternately on both ears by the researcher on a weekly basis. The labels are placed on the ear for five days each week and the elderly are instructed to remove them by the end of the fifth day or by those around them to prevent possible allergic reactions. It is also noted that if the Sides are separated during the five-day period, the researcher should be notified by telephone; In that case, the researcher, with the consent of the elderly person, will re-attach the sheets at his home, in the health center or wherever it is convenient for the elderly person. In addition, during the intervention, a weekly diary will be provided to the elderly person, in which he / she will specify signs of allergy and use of the new drug. The contents of the diary are organized using visual symbols in a way that can be understood and completed with simple training by all participants, including literate and illiterate. During the intervention period, all participants will be visited at the agreed location each week and new seeds will be affixed to them, and a diary will be delivered to them and another sheet will be delivered to them for the following week. No - There is not a plan to make this available Justification or reason for not sharing IPD is Not done yet
public Zahra Tagharrobi
Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0021 tagharrobi_z@yahoo.com Kashan University of Medical Sciences scientific Zahra Tagharrobi
Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan
kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0021 tagharrobi_z@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age 60 years and older Willingness to participate in the study Get a score higher than 25.5 from the COST tool Iranian citizenship Get a score higher than 5 from the GDS-15 tool Ability to communicate in Persian Organ health in the earlobe area 60 years no limit Both Allergy to glue (allergies, redness) or any intolerance Having a serious acute illness, hospitalization, lack of access Simultaneous use of other non-pharmacological methods using of acupuncture or acupuncture for the past three months addiction to drugs and alcohol based on the contents of the electronic health record exposure to severe stress (such as death of loved ones) from 3 months before the start of the study using of drugs that affect mood from three weeks before the start of the study Existence of other known psychiatric disorders and mental retardation based on the contents of the electronic health record F32.8 Other depressive episodes Treatment - Drugs Placebo uriculotherapy will be performed twice a day for four weeks, five days a week. In this group, Korean-made Vakaria brand DONG BANG will be glued by a researcher on the points of Shenman, Zero, Hart, Antiperspirant, and Master-Cerebral that are associated with depression. The elderly will be instructed to press these sideways twice a day, 60 times each time with the index finger and thumb, according to the intended schedule. During the 4 weeks of the intervention, the labels will be affixed alternately on both ears by the researcher on a weekly basis. The labels are placed on the ear for five days each week and the elderly are instructed to remove them by the end of the fifth day or by those around them to prevent possible allergic reactions. It is also noted that if the Sides are separated during the five-day period, the researcher should be notified by telephone; In that case, the researcher, with the consent of the elderly person, will re-attach the sheets at his home, in the health center or wherever it is convenient for the elderly person. Each participant will be taught how to press the sidewalls by researcher. In addition, during the intervention, a weekly diary will be provided to the elderly person, in which he / she will specify the number of times each time the pressure and use of the new drug. The contents of the diary are organized using visual symbols in a way that can be understood and completed with simple training by all partcipants, including literate and illiterate. During the intervention period, all participants will be visited at the agreed location each week and new seeds will be affixed to them, and a diary will be delivered to them and another sheet will be delivered to them for the following week. Control group:During the 4 weeks of the intervention, the labels will be affixed alternately on both ears by the researcher on a weekly basis. The labels are placed on the ear for five days each week and the elderly are instructed to remove them by the end of the fifth day or by those around them to prevent possible allergic reactions. It is also noted that if the Sides are separated during the five-day period, the researcher should be notified by telephone; In that case, the researcher, with the consent of the elderly person, will re-attach the sheets at his home, in the health center or wherever it is convenient for the elderly person. In addition, during the intervention, a weekly diary will be provided to the elderly person, in which he / she will specify signs of allergy and use of the new drug. The contents of the diary are organized using visual symbols in a way that can be understood and completed with simple training by all participants, including literate and illiterate. During the intervention period, all participants will be visited at the agreed location each week and new seeds will be affixed to them, and a diary will be delivered to them and another sheet will be delivered to them for the following week. Score of depression. Timepoint: Before the intervention - 4 weeks after the start of the intervention and 4 weeks after the end of the intervention. Method of measurement: Form 15 Questions for the Elderly Depression Scale (GDS-15). Kashan University of Medical Sciences Approved 2021-03-01 Kashan University of Medical Sciences Ethics Committee Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan kashan Isfehan Iran (Islamic Republic of)