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IRCT20151107024919N22 IRCT 2026-08-03 Kerman University of Medical Sciences The effect of Auricular acupressure on Nausea and Vomiting, Restless leg syndrome, and Sleep quality of patients undergoing hemodialysis referred to Imam Khomeini Hospital of Jiroft The effect of Auricular acupressure on Nausea and Vomiting, Restless leg syndrome, and Sleep quality of patients undergoing hemodialysis referred to Imam Khomeini Hospital of Jiroft 2026-08-11 anticipated 60 Recruiting https://irct.ir/trial/91892 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 intervention and sham groups in such a way that a list of people is prepared and then these people are numbered and divided into two intervention and sham groups using SPSS software version 27. In this way, we want the software to randomly place 30 people in the intervention group and 30 people in the sham 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 sham group. The information related to the intervention and sham 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 sham groups. N/A Condition 1: Hemodialysis. Condition 2: Nausea and vomiting. Condition 3: Restless legs syndrom. Intervention 1: Intervention group: in Intervention group,ear acupressure will be performed for 6 weeks, every other day. In this group , a trained and certified researcher , under the supervision a traditional medicine specialist, will identify the ear treatment points, disinfect the desired points with 70% alcohol, and apply vacaria seeds to the marked points of one ear of the patient using medical adhesive, applying unilaterally.To maintain the stability of the intervention, vacaria seeds of the same brand available on the market will be used. The points will include Shen Man, Zero, Thalamus, Subcortex, and Sympathetic points. After applying the seeds to one ear, patients will be instructed to press the desired points 4 times a day , 2 times in the morning and 2 times in the evening . There is a 5 minute interval between each pressing session. patients will massage each point with moderate pressure, equivalent to 5 to 7 out of 10, for 1 to 2 minutes or untill a feeling of warmth, numbness, or tingling occurs. between each massage session, and the next point will be followed by a 1 minute interval. the researcher will show the paticipants how to press the points correctly during the training. simultaneously with the hemodialysis sessions, every 2 to 3days, the old beads and adhesive will be removed from one ear and new beads will be attached to the opposite ear. In case of discomfort , skin sensitivity or intolerance caused by the acupressure adhesive or beads, the adhesives or beads will be removed and the intervention will be stopped for the patient. Intervention 2: Control group: In the sham(control) group, seedless adhesives will be used in non-specific locations behind the earlobe to maintain similar appearance. These adhesives will be similar in appearance to the intervention group but will have no specific therapeutic effect.Individuals in this group will be instructed not to apply any pressure to the adhesive site or take any specific action. the adhesive replacement and visits for this group will be scheduled at the same time as the intervention group so that the conditions of the two groups remain the same in terms of attention and contact with the researcher. to ensure patient adherence to the intervention , the researcher will be present in the ward for 1-2 dialysis sessions per week to directly monitor bead placement and pressure technique. on non-dialysis days, patients will record bead pressure sessions in a diary and will be followed up by the researcher by telephone. the diary will be reviewed during dialysis sessions where the researcher is present. 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 Batool 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 scientific Batool 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) Age between 18 and 60 years Having chronic kidney failure and undergoing regular hemodialysis 2 to 3 times a week Having at least 6 months of hemodialysis experience Full alertness and ability to respond to questionnaires Having a score of at least 4 in terms of Restless legs syndrome severity based on the RLS screening questionnaire Having a score of at least 5 on the Pittsburg Sleep Quality questionnaire Hemoglobin above 10 g/dl 18 years 60 years Both Having a cognitive impairment including Dementia or Alzhaeimer or sever psychiatric illness as reported by the patient or physician Having concurrent diseases including Cancer, Congestive Heart Failure, Connective Tissue disease or Blood diseases Having a wound, Infection, inflammation, or skin sensitivity in the ear area Simultaneous use of other similar methods such as Acupressure or Acupuncture during the study Use of Painkillers, including nonsteroidal anti-inflammatory drugs or opioids Taking sedatives and sleeping pills Absence from more than one intervention session Z49.01 R11 G25.81 Encounter for fitting and adjustment of extracorporeal dialysis catheter Nausea and vomiting Restless legs syndrome Other Placebo Intervention group: in Intervention group,ear acupressure will be performed for 6 weeks, every other day. In this group , a trained and certified researcher , under the supervision a traditional medicine specialist, will identify the ear treatment points, disinfect the desired points with 70% alcohol, and apply vacaria seeds to the marked points of one ear of the patient using medical adhesive, applying unilaterally.To maintain the stability of the intervention, vacaria seeds of the same brand available on the market will be used. The points will include Shen Man, Zero, Thalamus, Subcortex, and Sympathetic points. After applying the seeds to one ear, patients will be instructed to press the desired points 4 times a day , 2 times in the morning and 2 times in the evening . There is a 5 minute interval between each pressing session. patients will massage each point with moderate pressure, equivalent to 5 to 7 out of 10, for 1 to 2 minutes or untill a feeling of warmth, numbness, or tingling occurs. between each massage session, and the next point will be followed by a 1 minute interval. the researcher will show the paticipants how to press the points correctly during the training. simultaneously with the hemodialysis sessions, every 2 to 3days, the old beads and adhesive will be removed from one ear and new beads will be attached to the opposite ear. In case of discomfort , skin sensitivity or intolerance caused by the acupressure adhesive or beads, the adhesives or beads will be removed and the intervention will be stopped for the patient. Control group: In the sham(control) group, seedless adhesives will be used in non-specific locations behind the earlobe to maintain similar appearance. These adhesives will be similar in appearance to the intervention group but will have no specific therapeutic effect.Individuals in this group will be instructed not to apply any pressure to the adhesive site or take any specific action. the adhesive replacement and visits for this group will be scheduled at the same time as the intervention group so that the conditions of the two groups remain the same in terms of attention and contact with the researcher. to ensure patient adherence to the intervention , the researcher will be present in the ward for 1-2 dialysis sessions per week to directly monitor bead placement and pressure technique. on non-dialysis days, patients will record bead pressure sessions in a diary and will be followed up by the researcher by telephone. the diary will be reviewed during dialysis sessions where the researcher is present. Nausea and Vomiting. Timepoint: The effect of auricular acupressure on Nausea and Vomiting in Hemodialysis patients was evaluated in three stages including before the intervention, immediately after the end of the intervention week 6, and 4 weeks after the end of the intervention week 10. Method of measurement: Rhodes Index of Nausea and Vomiting. Restless Legs Syndrome. Timepoint: The effect of auricular acupressure on Restless Legs Syndrome in Hemodialysis patients was evaluated in three stages including before the intervention, immediately after the end of the intervention week 6, and 4 weeks after the end of the intervention week 10. Method of measurement: International Restless Legs Syndrome Scale. Sleep Quality. Timepoint: The effect of auricular acupressure on Sleep Quality in Hemodialysis patients was evaluated in three stages including before the intervention, immediately after the end of the intervention week 6, and 4 weeks after the end of the intervention week 10. Method of measurement: Pittsburgh Sleep Quality Index. Kerman University of Medical Sciences Approved 2026-07-20 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)