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IRCT20151107024919N14 IRCT 2022-12-12 Kerman University of Medical Sciences The effect of auricular acupressure on pruritus, xerostomia, and fatigue of patients undergoing hemodialysis in Kerman University of Medical Sciences The effect of auricular acupressure on pruritus, xerostomia, and fatigue of patients undergoing hemodialysis in Kerman University of Medical Sciences 2022-11-22 anticipated 82 Complete https://irct.ir/trial/66915 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: A simple randomization method is used to assign people to two control and intervention groups in such a way that a list of people is prepared and then these people are numbered and divided into two intervention and control groups using SPSS software version 26. In this way, we want the software to randomly place 41 people in the intervention group and 41 people in the control group, Blinding description: The intervention and collection of questionnaires and checklists are done by the researcher, and the data analyst is a person other than the researcher and does not know which data are related to the intervention group and which data are related to the control group. The information related to the intervention and control groups will be entered into SPSS software under the title of group 1 and group 2. The analyst will not know which of the groups 1 and 2 is the intervention and control groups. N/A Condition 1: pruritus. Condition 2: xerostomia. Condition 3: fatigue. Intervention 1: Intervention group: The intervention includes ear acupressure using Vacaria plant seeds in the specified points on the ear for the intervention group. The intervention lasts 4 weeks; According to the hemodialysis program, adhesives and beads will be replaced with new adhesives and beads every 2 to 3 days. Intervention 2: Control group: For people in the control group, adhesives without Vacaria plant seeds are used in specified places and only under their usual daily care. are placed and no intervention will be done on them. 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 The researcher doesn't have any interest to share because of ethical issues. ( there​ is No further information)
public Batoul Tirgari
Pardizeh Afzaalipour
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 B_tirgari@kmu.ac.ir Kerman University of Medical Sciences scientific Batoul Tirgari
Kerman University of Medical Sciences, Medical University Campus, Haft- Bagh- Alavi Highway, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 B_tirgari@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patient age between 18_75 years Regular hemodialysis Having at least 3 scores on the VAS visual analog scale for pruritus and experiencing xerostomia and fatigue in the last month 18 years 75 years Both Existence of concomitant diseases including: cancer, congestive heart failure, connective tissue disease, hematological diseases and liver diseases. The presence of severe physical symptoms that clearly cause insomnia and fatigue, such as bone pain, sleep apnea, and restless legs. Fatigue due to severe anemia (hemoglobin <60 g/L) or malnutrition (serum albumin <30 g/L) ear infection Allergy to Vaccaria seeds Use of medications that may cause xerostomia (such as anticholinergics, tricyclic antidepressants, and beta blockers) Use of drugs that may cause pruritus (such as drugs and substances to which the patient is allergic, narcotic painkillers, antifungals). L29.8 K11.7 R53 Other pruritus Disturbances of salivary secretion Malaise and fatigue Other Placebo Intervention group: The intervention includes ear acupressure using Vacaria plant seeds in the specified points on the ear for the intervention group. The intervention lasts 4 weeks; According to the hemodialysis program, adhesives and beads will be replaced with new adhesives and beads every 2 to 3 days. Control group: For people in the control group, adhesives without Vacaria plant seeds are used in specified places and only under their usual daily care. are placed and no intervention will be done on them. Pruritus. Timepoint: pruritus is measured before the intervention and at the end of the intervention. Method of measurement: Visual analog scale. Xerostomia. Timepoint: xerostomia is measured before the intervention and at the end of the intervention. Method of measurement: Summated Xerostomia Inventory. Fatigue. Timepoint: fatigue is measured before the intervention and at the end of the intervention. Method of measurement: Fatigue Severity Scale. Kerman University of Medical Sciences Approved 2022-11-07 Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)