Comparison of inflammatory factors before and after intervention in massage group with or without violet oil
Design
In this randomized clinical trial, 44 hemodialysis patients will select and, after completing the full description of the study, they will receive written consent andwere randomly divided into two groups by block method. In both groups, for the first two weeks, the severity of itching and the measurement of inflammatory factors, phosphoro and parathormomean will complet as control stage for two weeks. Then, in group 1, massage, and in group 2, massages with violet oil in the other hand without fistula will prescrib and after the intervention, the severity of itching and the measurement of inflammatory factors, phosphor and parathormone will repeat, and finally, the results in each group will compare with their control stage and also between the two groups.
Settings and conduct
In group 1, massage and in group 2, massages with violet oil - prepared on the basis of sweet almond oil - for 6 sessions (two weeks) in the other hand without fistula will prescrib
Participants/Inclusion and exclusion criteria
inclusion Criteria:
Age of 80 - 18 years
History of hemodialysis over three months
Lack of any skin problem causing itching
Having itching within 2 weeks before starting the sampling
Exclusion Criteria:
The patient's kidney transplant during the study
Sensitivity to used oil
Fistula in the study
Patient's personal decision to exit the plan
Itching of the patient due to skin problem
Peritoneal dialysis
Intervention groups
Massage with or without violet oil
Main outcome variables
Changes in serum inflammatory factors before & after intervention
General information
Reason for update
Acronym
UP , HD
IRCT registration information
IRCT registration number:IRCT20170607034382N3
Registration date:2019-01-07, 1397/10/17
Registration timing:registered_while_recruiting
Last update:2019-01-07, 1397/10/17
Update count:0
Registration date
2019-01-07, 1397/10/17
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
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage and topical rubbing of violet oil on inflammatory factors in hemodialysis patients
Public title
The effect of massage and violet oil on inflammatory factors in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of hemodialysis over three months
Lack of any skin problem causing
Having itching within 2 weeks before starting the sampling itching
Age of 80 - 18 years
Exclusion criteria:
The patient's kidney transplant during the study
Sensitivity to used oil
Fistula in the study
Patient's personal decision to exit the plan
Age
From 18 years old to 80 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized using random numbers table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Mashhad University of Medical Sciences
Street address
Faculty of Iranian and complementary Medicine, Campus University, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-12-01, 1397/09/10
Ethics committee reference number
IR.MUMS.REC.1397.246
Health conditions studied
1
Description of health condition studied
Pruritus
ICD-10 code
N17-N19
ICD-10 code description
End stage kidney disease: on dialysis
2
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
Inflammatory factors
Timepoint
Before and after the study
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Massage without oil
Category
Treatment - Devices
2
Description
Intervention group: Massage with oil
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Montasereyyeh Hospital
Full name of responsible person
Seyyed Majid Ghazanfari
Street address
Imam Khomeini 25 - Imam Khomeini Street - Golestan Street - Mashhad