Explanation of Hekka in the Iranian Medicine School and The Effect of Massage and Topical Rubbing of Violet oil on the severity of Pruritus in Hemodialysis Patients
Objective: The aim of this study was to evaluate the effect of massage with and without violet oil on pruritus relief and quality of life in hemodialysis patients.
Design: The study is designed for two groups of 24 people.
Setting and conduct: At first, for two weeks, the severity of itching questionnaire is completed. Then, for two weeks, both groups are intervened. In the first group, only massage is performed and in the second group massage with topical use of 5% violet oil in almond oil base.
The entry criteria for participants included in the study included ages 65-18, a history of more than three months of hemodialysis, non-use of other methods to heal itching during the study, itching within 2 weeks before starting the sampling.
The exclud criteria for participants excluded from the study included the kidney transplantation during the study, the sensitivity to the oil used, the patient's dissatisfaction with the continuation of the plan.
Interventions include massage and massage with topical use of violet oil.
The main outcome variables include relieving the severity of pruritus and improving the quality of life of the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091334382N1
Registration date:2017-09-27, 1396/07/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Seyed Majid Ghazanfari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4423 1041
Email address
ghazanfarim941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Cancellor for Research,Mashhad University of Medical
Sciences
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Explanation of Hekka in the Iranian Medicine School and The Effect of Massage and Topical Rubbing of Violet oil on the severity of Pruritus in Hemodialysis Patients
Public title
The Effect of Massage and Topical Rubbing of Violet oil on the severity of Pruritus in Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Enterance Criteria:
1. Age 18 - 65years
2. History of hemodialysis over three months
3. Failure to use other methods to eliminate itching during the study
4. Lack of any skin problem causing itching
5. Itching within 2 weeks before starting the sampling
6. Severity of itching more than 3
Exit Criteria:
1. Patient's kidney transplantation during the study
2. Sensitivity to the oil used
3. Fistula in the study
4. The tendency to use other methods to reduce the severity of itching
5. Change the way the patient continues treatment
6. Personal decision of the patient to withdraw from the plan
7. Patient's dissatisfaction with the continuation of the plan
8. Itchy patient due to skin problem
9. Peritoneal dialysis
10. The patient's unwillingness to financially
11. Serum Phosphorus Level in Patient Tests
12. Serum hormone levels in the patient's parathormone variables
13. Serum blood level of blood urea nitrogen in patient's tests
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:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The randomization method is a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical
Street address
Azadi Square, Ferdowsi University, Pardis, Mashhad University of Medical Sciences, Faculty of Traditional Medicine and Supplement
City
Mashhad
Postal code
Approval date
2017-08-12, 1396/05/21
Ethics committee reference number
IR.MUMS.REC.1396.174
Health conditions studied
1
Description of health condition studied
Pruritus in Hemodialysis Patients
ICD-10 code
(N17-N19)
ICD-10 code description
End stage kidney disease: on dialysis
Primary outcomes
1
Description
Severity of Pruritus
Timepoint
Before and after the study
Method of measurement
Pruritus Scale (VAS)
2
Description
skin dryness
Timepoint
Before and after the study
Method of measurement
questionnaire
Secondary outcomes
1
Description
Quality of life for patients with kidney disease
Timepoint
Before and after the study
Method of measurement
questionnaire
Intervention groups
1
Description
Massage without oil
Category
Treatment - Devices
2
Description
Massage with oil
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan Dialysis Center
Full name of responsible person
Seyyed Majid Ghazanfari
Street address
Azadi Square, Ferdowsi University, Pardis, Mashhad University of Medical Sciences, Faculty of Traditional Medicine and Supplement
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research,Mashhad University of Medical
Full name of responsible person
Dr. Mohsen Tafaghodi, Research Vice Chancellor
Street address
Vice Chancellery for Research of Mashhad University of
City
Mashhad
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,Mashhad University of Medical
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
Mashhad University of Medical Sciences, Faculty of Traditional Medicine and Supplement
Full name of responsible person
Seyyed Majid Ghazanfari
Position
Persian Traditional Medicine Student
Other areas of specialty/work
Street address
Azadi Square, Ferdowsi University, Pardis, Mashhad University of Medical Sciences, Faculty of Traditional Medicine and Supplement
City
Mashhad
Postal code
Phone
+98 51 3884 8931
Fax
Email
Ghazanfarim941@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Traditional
Full name of responsible person
Ali Khorsand Vakilzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Azadi Square, Ferdowsi University, Pardis, Mashhad University of Medical Sciences, Faculty of Traditional Medicine and Supplement
City
Mashhad
Postal code
Phone
+98 51 3884 8931
Fax
Email
khorsanda@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Traditional Medicine and Supplement
Full name of responsible person
Seyyed Majid Ghazanfari
Position
Persian Traditional Medicine Student
Other areas of specialty/work
Street address
Azadi Square, Ferdowsi University, Pardis, Mashhad University of Medical Sciences, Faculty of Traditional Medicine and Supplement
City
Mashhad
Postal code
Phone
00
Fax
Email
Ghazanfarim941@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)