Determining the effect of ear acupressure on pruritus, xerostomia and fatigue of hemodialysis patients in centers affiliated to Kerman University of Medical Sciences.
Design
En This study is a clinical trial with two groups, single blinded and randomized, with 41 patients in each group
Settings and conduct
This study will be conducted in the hemodialysis departments of the centers affiliated to Kerman University of Medical Sciences. In the intervention group, ear acupressure will be performed for 4 weeks. All types of itching, dry mouth and fatigue before the intervention and after the end of the intervention will be measured in two intervention and control groups.
Participants/Inclusion and exclusion criteria
Entry criteria include: age 18 to 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.
Exclusion criteria: presence 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 or malnutrition؛ ear infection؛ Allergy to Vaccaria seeds؛ Using medications that may cause xerostomia and itching.
Intervention groups
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. 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.
Main outcome variables
pruritus, xerostomia, and fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151107024919N14
Registration date:2022-12-12, 1401/09/21
Registration timing:registered_while_recruiting
Last update:2022-12-12, 1401/09/21
Update count:0
Registration date
2022-12-12, 1401/09/21
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
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of auricular acupressure on pruritus, xerostomia, and fatigue of patients undergoing hemodialysis in Kerman University of Medical Sciences
Public title
The effect of auricular acupressure on pruritus, xerostomia, and fatigue of patients undergoing hemodialysis in Kerman University of Medical Sciences
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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).
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
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 (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 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.
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
7616913555
Approval date
2022-11-07, 1401/08/16
Ethics committee reference number
IR.KMU.REC.1401.316
Health conditions studied
1
Description of health condition studied
pruritus
ICD-10 code
L29.8
ICD-10 code description
Other pruritus
2
Description of health condition studied
xerostomia
ICD-10 code
K11.7
ICD-10 code description
Disturbances of salivary secretion
3
Description of health condition studied
fatigue
ICD-10 code
R53
ICD-10 code description
Malaise and fatigue
Primary outcomes
1
Description
pruritus
Timepoint
pruritus is measured before the intervention and at the end of the intervention.
Method of measurement
Visual analog scale
2
Description
xerostomia
Timepoint
xerostomia is measured before the intervention and at the end of the intervention.
Method of measurement
Summated Xerostomia Inventory
3
Description
fatigue
Timepoint
fatigue is measured before the intervention and at the end of the intervention.
Method of measurement
Fatigue Severity Scale
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Other
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Batool Tirgari
Street address
No. 1, End of Shafa Ave., Shafa Eduacational Hospital.
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
B_tirgari@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/snm
2
Recruitment center
Name of recruitment center
Saman Al-Hajj Charity Organization
Full name of responsible person
Batol Tirgari
Street address
No. 78, Shahid Rajaei st
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3271 5062
Email
B_tirgari@kmu.ac.ir
3
Recruitment center
Name of recruitment center
Javad Al-Aimah Specialized Medical Complex
Full name of responsible person
Batol Tirgari
Street address
Kerman، Abuzar، Alley No. 25
City
Kerman
Province
Kerman
Postal code
7617763811
Phone
+98 34 3251 2098
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
DR 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?
No
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
Batoul Tirgari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardizeh Afzaalipour
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
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
Batoul Tirgari
Position
Associate 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
Fax
+98 34 3132 5184
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
Batoul Tirgari
Position
Associate 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
Fax
+98 34 3132 5184
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