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IRCT20110912007529N28 IRCT 2023-07-10 Shahed University Comparing the effect of auricular acupressure and body acupressure on pain and anxiety Comparing the effect of auricular acupressure and body acupressure on pain and anxiety in older adults undergoing knee replacement arthroplasty 2023-08-23 anticipated 141 Complete https://irct.ir/trial/71025 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Hundred & one cards (equal to the number of sample volumes) will be prepared. Then A, B, or C will be written on each card (47 cards A, 47 cards B, and 47 cards C). These cards will be placed inside an opaque box so that no one can see the cards inside the box. In this way, three cards are prepared and one of the words A (acupressure), B (auriculotherapy), and C (control) will be written on each card. After shuffling the cards by the researcher, patients are asked to randomly take a card from the box (selected cards will not be returned to the box after selection). This process will continue until the sample size is completed. N/A Knee joint replacement. Intervention 1: Intervention group: interventional therapy ear acupuncture At first, disinfection of both outer auricles using 70% alcohol, and then during 3 days, every day three times, each time for each point 3 minutes medium equitability on glue ear (ear plaster containing seed) on a three-point on the auricle, Shen Men, knee, Thalamus given. Intervention 2: Intervention group: interventional therapy body acupuncture including: At first, during 3 days, every day three times, each time for each point 3 minutes (on a three-point on the Hegu LI4 (LargIntestine4), LI10(Shousanli) and Yintang). Intervention 3: Control group: This group is provided by routine care. Yes - There is a plan to make this available What will be shared: Information about the original outcome after being unidentifiable is shared. When: The access period is up to after the publication of the results. To whom: Results is available to academic researchers Conditions: A new analysis of the data can only be done by explaining the reasons for the request for such an analysis and with the knowledge of the researcher. Where to obtain: They can correspond with the person responsible for this clinical trial(Nahid Rejeh) to receive the data (nrejeh@yahoo.com.) How to obtain: After receiving the application for having a data file and obtaining permission from the university vice-chancellor, the data file after the publication of the results is shared Comments:
public Dr. Nahid Rejeh
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 2100 nrejeh@yahoo.com Shahed University scientific Dr. Nahid Rejeh
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 000 nrejeh@yahoo.com Shahed University Iran (Islamic Republic of) Age 60 years and over Absence of cognitive impairment Ability to communicate Non-alcohol and drug addiction Lack of experience or simultaneous participation in similar training sessions Lake of history of mental illness The first experience with knee replacement arthroplasty Undergoing spinal anesthesia Lake of malignancy, lake of inflammatory disease, and vascular disease Having no active bleeding, sensory disorders, pain, infectious wounds and skin disease at the intervention site 60 years no limit Female Unwillingness to co-operate with a patient or physician Return to the operating room Other Other N/A Intervention group: interventional therapy ear acupuncture At first, disinfection of both outer auricles using 70% alcohol, and then during 3 days, every day three times, each time for each point 3 minutes medium equitability on glue ear (ear plaster containing seed) on a three-point on the auricle, Shen Men, knee, Thalamus given Intervention group: interventional therapy body acupuncture including: At first, during 3 days, every day three times, each time for each point 3 minutes (on a three-point on the Hegu LI4 (LargIntestine4), LI10(Shousanli) and Yintang). Control group: This group is provided by routine care. Intensity of pain. Timepoint: Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day. Method of measurement: Visual Pain Scale. Quality of pain. Timepoint: Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day. Method of measurement: MacGill questionnaire. Intensity of anxiety. Timepoint: Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day. Method of measurement: Visual Analogue Scale Anxiety) VASA). Quality of anxiety. Timepoint: Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day. Method of measurement: The Spielberger Inventory. Blood pressure. Timepoint: Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day. Method of measurement: Digital arm l sphygmomanometer. Pulse rate. Timepoint: Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day. Method of measurement: Enumeration of pulse rate. Respiration rate. Timepoint: Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day. Method of measurement: Enumeration of Respiration rate. Shahed University Approved 2023-06-19 Ethics committee of Shahed University Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran. Iran Tehran Tehran Iran (Islamic Republic of)