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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

Protocol summary

Study aim
To determine 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
Design
In this study is a clinical trial with two control (sham)and intervention groups, single-blinded and randomized, with 30 patients in each group, randomization was done using a simple method using spss27 software.
Settings and conduct
This study will be conducted in the hemodialysis department of Imam Khomeini Hospital in Jiroft. the study outcomes will be evaluated in three stages: before the start of the intervention, immediately after the end of the intervention (week 6), and 4 weeks after the end of the intervention (week 10) in two intervention and control (sham) groups.
Participants/Inclusion and exclusion criteria
Entry criteria include:Age between 18 and 60 years, undergoing regular hemodialysis 2 to 3 times a week, Having at least 6 months of hemodialysis experience. Exclusion criteria :Having a cognitive impairment,Taking sedatives and sleeping pills, Absence from more than one intervention session
Intervention groups
Intervention group: in Intervention group,ear acupressure will be performed for 6 weeks, every other day. 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 .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.
Main outcome variables
Auricular acupressure, Restless legs syndrom, Nausea and vomiting, Sleep quality.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151107024919N22
Registration date: 2026-08-03, 1405/05/12
Registration timing: prospective

Last update: 2026-08-03, 1405/05/12
Update count: 0
Registration date
2026-08-03, 1405/05/12
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-11, 1405/05/20
Expected recruitment end date
2026-11-11, 1405/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616910002
Approval date
2026-07-20, 1405/04/29
Ethics committee reference number
IR.KMU.REC.1405.180

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
Z49.01
ICD-10 code description
Encounter for fitting and adjustment of extracorporeal dialysis catheter

2

Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

3

Description of health condition studied
Restless legs syndrom
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome

Primary outcomes

1

Description
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

2

Description
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

3

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Other

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemodialysis Center Imam Khomeini Hospital of Jiroft of Jiroft
Full name of responsible person
Batool Tirgari
Street address
Jiroft, Imam Khomeini Boulevard , Shafa Street
City
Jiroft
Province
Kerman
Postal code
7861933667
Phone
+98 913 195 0716
Email
b_tirgari@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Street address
Razi Nursing and Midwifery School, Medical Sciences Campus, Haft baghe alavi Road, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
B_tirgari@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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