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IRCT20220119053765N1 IRCT 2022-04-14 Bojnourd University of Medical Sciences The effect of Auriculotherapy on anxiety The effect of Auriculotherapy on anxiety in elderly candidates for coronary angiography 2022-04-16 anticipated 90 Complete https://irct.ir/trial/62101 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants in the study will not know the type of intervention received, Blinding description: Sampling in this study will be initially purposeful method and according to the inclusion criteria and then random assignment of individuals to three groups through permutation blocks. First, with the help of computer software, a list of random codes with a permutation block approach proportional to the estimated sample size, ie at least 90 people in three groups will be generated. So the eligible seniors will receive a unique code in order of identification and will be placed in each of the three study groups. At online software (https://www.sealedenvelope.com) will be used for permuted block randomization. N/A Aanxiety. Intervention 1: Intervention group 1: In this group, from three days before angiography, Magnetic bead labels, in Shenman, relaxation, tranquilizer and endocrine points are placed on one ear and patients will be asked to press each label three times a day by finger for one minute. Intervention 2: Intervention group 2: In this group, three days before angiography, beadless labels, in Shenman, relaxation, tranquilizer and endocrine points are placed on one ear and patients will be asked to press each label three times a day by finger for one minute. Intervention 3: Control group: There will be no intervention in the control group and routine care will be performed. 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 Najmeh Zeinali
Shahriar St., south side of Imam Ali Hospital
bojnurd Iran (Islamic Republic of) 9678694176 +98 58 3229 7096 Najmehzeinaly@gmail.com Bojnourd University of Medical Sciences scientific Hamed Mortazavi
Shahriar St., south side of Imam Ali Hospital
Bojnurd Iran (Islamic Republic of) 9678694176 +98 58 3229 7096 hamedmortazavi@ymail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Age older than 60 years old Be literate The patient or a close family member of the patient Doing angiography for the first time 60 years no limit Both Non-emergency angiography Not undergoing complementary therapies No ear lesions (sores, eczema, urticaria, etc.) No history of cases such as: cognitive disorders, anxiety, stress and depression, Parkinson's, Alzheimer's based on medical history of the patients, use sedatives drugs, and previous auriculotherapy F06.4 Anxiety disorder due to known physiological condition Treatment - Devices Treatment - Devices N/A Intervention group 1: In this group, from three days before angiography, Magnetic bead labels, in Shenman, relaxation, tranquilizer and endocrine points are placed on one ear and patients will be asked to press each label three times a day by finger for one minute. Intervention group 2: In this group, three days before angiography, beadless labels, in Shenman, relaxation, tranquilizer and endocrine points are placed on one ear and patients will be asked to press each label three times a day by finger for one minute. Control group: There will be no intervention in the control group and routine care will be performed. Anxiety score in the elderly Candidate for coronary angiography. Timepoint: At the beginning of the study (before the intervention) and three days after the intervention (half an hour before angiography). Method of measurement: Spielberger state- trait anxiety inventory. Mashhad University of Medical Sciences Bojnourd University of Medical Sciences Mashhad University of Medical Sciences Approved 2022-01-10 Ethics committee of North Khorasan University of Medical Sciences Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnurd Bojnurd North Khorasan Iran (Islamic Republic of)