Determining the effect of acupressure on the severity and quality of uremic uremic hemodialysis patients
Design
A total of 105 patients from the study population were selected by consecutive sampling method and classified into six groups using randomized software and divided into three groups: A (test group) and B (control group) and C (group Sham) will be assigned. The randomization sequence will be secretly executed
Settings and conduct
To apply acupressure in the test group, first determine the points and then a 2-minute massage for each point in the form of a 5-second massage and 1 second rest with a rotational speed of 2 times per second with an approximate pressure of 3-4 kg applied by the thumb. Gets This is a total of 16 minutes of acupressure in the first half of each hemodialysis session. Intervention for 4 weeks, 3 times a week and a total of 12 sessions. This study will be without blindness.
Participants/Inclusion and exclusion criteria
Hemodialysis three times a week for each session for 3-4 hours
Dialysis in the last 6 months Having a pruriac uremic for at least 1 month from your doctor's diagnosis
Having at least the severity of itching 3 based on the anal scaling of the itchy
Intervention groups
To apply acupressure in the test group, SP10 points (), (ST36), (SP6), LI11) should be determined in two places in the target areas. In the sham group, the pressure is carried out at a distance of 1 to 1.5 cm from the main points for a similar period. In the control group, participants receive only routine clinical treatment without acupressure intervention.
Main outcome variables
uremic Pruritus and Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190626044029N1
Registration date:2019-07-14, 1398/04/23
Registration timing:prospective
Last update:2019-07-14, 1398/04/23
Update count:0
Registration date
2019-07-14, 1398/04/23
Registrant information
Name
Eghlima Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3523 0165
Email address
eghlimajalali@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-11, 1398/05/20
Expected recruitment end date
2019-09-11, 1398/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on the severity and quality of uremic Pruritus in hemodialysis patients
Public title
The effect of acupressure on the severity and quality of uremic Pruritus in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis three times a week for each session for 3-4 hours
Dialysis in the last 6 months
Having a pruriac uremic for at least 1 month from your doctor's diagnosis
Having at least the severity of itching (3) based on the analogue visual analogue scale
Cognitive ability to answer questions
Age of patients aged 20 to 65 years
Exclusion criteria:
Admission and transfer to special sections
Skin diseases causing itching and allergies
Having nervous and vascular disorders to diagnose a doctor who has an effect on itching and sensation
Change the duration and frequency of dialysis for any reason
Change in the type of drug used to affect itching
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Seventh Tir Square, Shahroud University of Medical Sciences and Health Services
City
Shahrud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2019-06-23, 1398/04/02
Ethics committee reference number
IR.SHMU.REC.1398.026
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
uremic itching
Timepoint
Weeks zero, four and twelve after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Quality of Life
Timepoint
Weeks zero, four and twelve after intervention
Method of measurement
Yusupovich's itching questionnaire
Intervention groups
1
Description
First, points (SP10), (ST36), (SP6), (LI11) are determined bilaterally in the desired locations. Then a 2-minute massage for each spot is performed for 5 seconds and a 1 second rest is performed at a rotational speed of 2 times per second with a pressure of approximately 3-4 kg by hand thumb. This is a total of 16 minutes of acupressure in the first half of each hemodialysis session. Intervention for 4 weeks, 3 times a week and a total of 12 sessionstoes in the left and right hands are generally applied in 8 points. The duration of each acupressure session is about 16 minutes
Category
Treatment - Other
2
Description
Control group: For the same period, massage at inaccurate points 1 to 1.5 cm from the actual points used in the test group
Category
Placebo
3
Description
Control group: No intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Shahroud Hospital
Full name of responsible person
Eghlima Jalali
Street address
Imam Street, 28 m. End of Bandarzin, Imam Hossein Hospital
City
Shahroud
Province
Semnan
Postal code
۳۶۱۶۹۱۱۱۵۱
Phone
+98 23 3234 2000
Email
Imamahosein@shmu.ac.ir
2
Recruitment center
Name of recruitment center
Velayat
Full name of responsible person
Eghlima jalali
Street address
Student Square- Cheshme Ali Ali Blvd - Damghan velayath Hospital
City
Damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5129
Email
velayathos@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamiyan
Street address
Seventh Tir Square, Shahroud University of Medical Sciences and Health Services
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 0059
Email
eghlimajalali@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Eghlima Jalali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahroud, Seventh Tir Square, Shahrood University of Medical Sciences
City
Shahrud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴
Phone
+98 23 3523 0165
Fax
Email
eghlimajalali@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Eghlima Jalali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahroud, Seventh Tir Square, Shahrood University of Medical Sciences
City
Shahrud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴
Phone
+98 23 3523 0165
Fax
Email
eghlimajalali@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Eghlima Jalali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahroud, Seventh Tir Square, Shahrood University of Medical Sciences
City
Shahrud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴
Phone
+98 23 3523 0165
Fax
Email
eghlimajalali@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the quality and severity of itching can be shared.
When the data will become available and for how long
Start one year after publishing results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Researchers have a printed article
From where data/document is obtainable
eghlima jalali- eghlima jalali@gmail.com
What processes are involved for a request to access data/document