Protocol summary

Summary
The aim of this study is to investigate the efficacy of acupressure therapy on uremic pruritus, quality of life, and laboratory parameters of patients with hemodialysis. The study population consists of all the subjects who were undergoing hemodialysis in three educational hospitals. Subjects who are on dialysis for at least 6 months and they have experienced itching at least for 3 months will be included and who have history of non uremic itching, liver disease, cancer, psychiatric disorder and current infection will be excluded from study. The sample size is 90 patients that will be recruited in three groups by block randomization method. In this clinical trail the baseline measurements include itching severity scale, quality of life questionnaire, and laboratory tests. The intervention will be done during four weeks. In the first intervention group a one-minute pressure [4 (kg)] and consequently three consecutive pressures will be applied by researcher's thumb on SP6, SP10, ST36, LI-11 points. In second intervention group, pressure will be applied 1-2 centimeter far from mentioned points with similar technique and duration. The control group did not receive any intervention expect general therapies. Post-test will be performed within one week after completion of the intervention. Severity of pruritus was measured at the end of second week of intervention. Data will be collected using 5-D pruritus questionnaire, and quality of life questionnaire (Itching Qol) for itching.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041917546N8
Registration date: 2017-07-05, 1396/04/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-05, 1396/04/14
Registrant information
Name
Marzieh Momennasab
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
momennasab@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-06-16, 1396/03/26
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomised Clinical Trial of Effect of acupressure of points SP6,SP10,ST36,LI-11 on uremic pruritus, quality of life, and laboratory parameters in hemodialysis patients
Public title
Effect of acupressure on severity of pruritus, quality of life, and laboratory parameters in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients Must be on dialysis for at least 6 months; Their age should be in range of 18 to 65 years; Having itching at least for 3 months; Must be on dialysis at least three times a week for 3-4 hours; Should have intact sense in acupressure points. Exclusion criteria: The patient declines to cooperate; There is wound at acupressure points; Suffering from viral hepatitis or AIDS, Being hospitalized in the last month; Having any surgery; amputation or neuropathy in the last three months; Having history of non uremic itching, liver disease, cancer, psychiatric disorder and current infection.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study randomization will be done by blocking method.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Av, The Central Building of Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.SUMS.REC.1395.198

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 pruritus
Timepoint
Before. The end of the second week and the end of the fifth week after beginning the intervention
Method of measurement
5-D Pruritus Scale

2

Description
Quality of Life
Timepoint
Before and the end of fifth week after beginning the intervention
Method of measurement
Quality of Life Questionnaire in patients with pruritus (Itchy QoL)

3

Description
Biochemical parameters including hemoglobin, hematocrit, phosphorus, calcium, sodium, potassium, PTH, BUN, and Cr
Timepoint
Before and the end of fifth week after beginning the intervention
Method of measurement
Blood sample

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group 1: In this group intervention will be done three times a week during dialysis. A one-minute pressure amount of 4 (kg) will be applied on SP6, SP10, ST36, LI-11 points by the research using thumb. Also, three consecutive pressures were applied in each point.
Category
Other

2

Description
Intervention group2: In this intervention group, pressure will be applied in sham-control points that are 1-2 centimeter far from major points with similar technique and duration.
Category
Other

3

Description
control group: Without intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Fateme Karjalian
Street address
Next to Medical School, Zand Avenue, Shiraz, Iran
City
Shiraz

2

Recruitment center
Name of recruitment center
Amiralmomenin brun hospital
Full name of responsible person
Fateme Karjalian
Street address
Km 2 Sadra, Amiralmomenin burn and plastic hospital
City
Sadra

3

Recruitment center
Name of recruitment center
Nemazee hospital
Full name of responsible person
Fateme Karjalian
Street address
Namazee square, Zand Avenue, Shahid Faghihi Hospital, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
7th floor, central building of Shiraz University of Medical Science, Zand boulevard
City
Shiraz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hazrate Fateme nursing and midwifery school
Full name of responsible person
Dr. Marzieh Momennasab
Position
assistant professor
Other areas of specialty/work
Street address
First floor, Hazrate Fateme nursing and midwifery school, Namazee square
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
momennasab@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hazrate Fateme nursing and midwifery school
Full name of responsible person
Dr. Marzieh Momennasab
Position
assistant professor
Other areas of specialty/work
Street address
First floor, Hazrate Fateme nursing and midwiferyschool, Nanazi square
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
momennasab@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hazrate Fateme nursing and midwifery school
Full name of responsible person
Fateme Karjalian
Position
MS nursing student
Other areas of specialty/work
Street address
Hazrate Fateme nursing and midwifery school, Namazi square Shiraz
City
Shiraz
Postal code
Phone
+98 71 3647 4255
Fax
Email
karjalian1990@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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