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IRCT20091219002889N13 IRCT 2022-11-07 Esfahan University of Medical Sciences Auriclotherapy on stress, anxiety and depression after mastectomy Investigating the effect of auriclotherapy on the level of stress, anxiety and depression after mastectomy in women with breast cancer 2022-10-26 anticipated 70 Complete https://irct.ir/trial/66429 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: At this stage, the trained person provides the sealed envelopes in which intervention and control groups are registered as number one and number two, respectively and hidden , and they are randomly assigned to two intervention and control groups. They find that neither the patients were previously aware of their choice nor the researcher has any knowledge in this field, Blinding description: The questionnaire will be distributed among the patients by another trained person and will be completed and delivered by the patients. The trained person will determine the score of the questionnaire. Then the people who have obtained a score of 19 and above from the three scales of stress, anxiety and depression of the DASS questionnaire and meet the inclusion criteria will be included in the study. At this stage, the trained person provides the sealed envelopes in which intervention and control groups are registered as number one and number two, respectively and hidden , and they are randomly assigned to two intervention and control groups. They find that neither the patients were previously aware of their choice nor the researcher has any knowledge in this field. N/A stress, anxiety and depression. Intervention group: They undergo ten weekly sessions of auriclotherapy (Relax, Mr. Shoulder, Long 2, Anxiety, Shen Man and Thalamic points) and then Vaccaria seeds is placed on the corresponding points. Then, the patients are advised to press the pads for one minute every hour, and at the end of the week, they will come back and be stimulated again and the pads will be applied.. Yes - There is a plan to make this available What will be shared: Part of the data, such as the information related to the main outcome, will be published in the articles resulting from this study and the final report. When: The access period starts 6 months after the results are published To whom: Secondary data will be available only to researchers working in academic and scientific institutions Conditions: Data will only be available for use in meta-analysis studies. Where to obtain: To receive the data, contact the responsible person in this study via email. How to obtain: After sending the request from the academic person, the email will be checked and after confirming the purpose of accessing the data, the person responsible for the study will respond to the request as soon as possible. Comments:
public Mahboubeh Valiani
Isfahan University of Medical Sciences - Faculty of Nursing and Midwifery - Department of Midwifery and Reproductive Health
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 7153 valiani@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Mahboubeh Valiani
Isfahan University of Medical Sciences - Faculty of Nursing and Midwifery - Department of Midwifery and Reproductive Health
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 7153 valiani@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iranian nationality At least two weeks have passed since the mastectomy Reproductive age Obtaining a score of at least 19 in the DASS questionnaire before intervention 15 years 54 years Female Not suffering from infectious diseases and other neurological diseases such as MS Absence of infection and apparent abnormality in the ear Non-use of complementary medicine techniques during the last two months F43 Reaction to severe stress, and adjustment disorders Treatment - Other Intervention group: They undergo ten weekly sessions of auriclotherapy (Relax, Mr. Shoulder, Long 2, Anxiety, Shen Man and Thalamic points) and then Vaccaria seeds is placed on the corresponding points. Then, the patients are advised to press the pads for one minute every hour, and at the end of the week, they will come back and be stimulated again and the pads will be applied. Score of stress, anxiety and depression in DASS questionnaire. Timepoint: Before and after intervention. Method of measurement: The depression anxiety stress scale. Esfahan University of Medical Sciences Approved 2022-01-15 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)