A comparision Study of the effect of massage therapy with and without Essential oils on uremic pruritus of hemodialysis women who referred to teaching hospitals in Urmia in 2019-20
Determination and comparison of the effect of massage with and without aromatic oils on uremic pruritus of women undergoing hemodialysis referred to Urmia educational-medical centers in 1389-99
Design
The present study is a clinical trial to evaluate pruritus in hemodialysis patients. In this Research among 100 hemodialysis female patients , 100 patients were selected by convenience sampling method and randomly assigned using web-based software Randomizer was divided into one control group and three intervention groups (lavender, violet and blank massage groups) (25 patients each). The subjects of this study are parallel and non-blinded groups.
Settings and conduct
The present study is a clinical trial to evaluate pruritus in hemodialysis patients. In this Research among 100 hemodialysis patients referred to Imam Khomeini and Taleghani educational centers of Urmia, 100 patients were selected by convenience sampling method and randomly assigned to a control group and three groups. Intervention (lavender, violet and blank massage groups) will be divided. The researcher will refer to the Urmia training centers by receiving a code of ethics and a formal letter from the university. The study and the method of the research work give them written informed consent to participate in the study Dead. The researcher will collect data in three stages.
Participants/Inclusion and exclusion criteria
1) At least 6 months of hemodialysis treatment
2) Willingness to participate in the study
3) No other skin problems
4) womans over 18 and under 85 years
1) Kidney transplant or no hemodialysis for any reason
2) pregnancy, lactation and diabetes
3) Use other pruritus control methods
Intervention groups
Group 1) Massage with lavender oil
Group 2) Massage with violet oil
Group 3) Massage without oil
Group 4) Control group
Main outcome variables
Uremic pruritus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191205045624N1
Registration date:2019-12-13, 1398/09/22
Registration timing:registered_while_recruiting
Last update:2019-12-13, 1398/09/22
Update count:0
Registration date
2019-12-13, 1398/09/22
Registrant information
Name
Zahra Heidarnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4916
Email address
zheidarnia62@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparision Study of the effect of massage therapy with and without Essential oils on uremic pruritus of hemodialysis women who referred to teaching hospitals in Urmia in 2019-20
Public title
A comparision Study of the effect of massage therapy with and without Essential oils on uremic pruritus of hemodialysis women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Female gender (because she is a female researcher and personally massage the patients, she chooses only the female sample to observe her ethical and convenience in conducting the research)
2) At least 6 months of hemodialysis treatment
3) a history of at least two weeks uremic pruritus
4) No history of psychiatric treatment and mourning for the past 6 months
5) Willingness to participate in the study
6) No other skin problems
7) Lack of infectious diseases, AIDS and hepatitis
8) Failure to receive any treatment that disrupts mental ability, memory or thinking
9) Have dialysis sessions at least 3 times a week
10) Age over 18 and less than 85 years
Exclusion criteria:
1) Kidney transplant or no hemodialysis for any reason
2) pregnancy, lactation and diabetes
3) Use other pruritus control methods
Age
From 18 years old to 85 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the inclusion criteria, 100 patients were selected by convenience sampling method and randomly assigned using Randomizer web-based software that was able to generate random sequences by blocking method and assigned the samples to a control group (Group I). And will be divided into three intervention groups (groups II, III, IV) (25 patients each).
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
Urmia University of Medical Sciences
Street address
Urmia, Nazlo Campus, Urmia University of Medical Sciences, School of Nursing and Midwifery
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Approval date
2019-09-04, 1398/06/13
Ethics committee reference number
IR.UMSU.REC.1398.212
Health conditions studied
1
Description of health condition studied
Uremic pruritus in hemodialysis women
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Uremic pruritus
Timepoint
Before and after intervention
Method of measurement
Pruritus Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Massage the forearm and arm without fistula with lavender oil in the amount of 3–5 cc of lavender oil for 20 minutes (forearm and arm each 10 minutes).
Category
Treatment - Drugs
2
Description
Intervention group: Massage the forearm and arm without fistula with violet oil in the amount of 3–5 cc of lavender oil for 20 minutes (forearm and arm each 10 minutes).
Category
Treatment - Drugs
3
Description
Intervention group: Fistula-free forearm and arm massage will be performed without using lavender and violet oil for 20 minutes (forearm and arm each 10 minutes).
Category
Treatment - Other
4
Description
Control group: In this group there are hemodialysis patients with no intervention. Patients in this group are only monitored.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Imam Khomeini and Taleghani Hospitals
Full name of responsible person
Zahra Heidarnia
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4916
Fax
+98 44 3275 4921
Email
zheidarnia62@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi, Deputy of Research and Technology of Urmia University of Medical Sciences
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4916
Email
zheidarnia62@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Zahra Heidarnia
Position
MSc Student of Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4916
Email
zheidarnia62@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hossein Habibzadeh
Position
science Committee, Associate Professor of Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4916
Email
Habibzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zahra Heidarnia
Position
MSc Student of Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4916
Email
zheidarnia62@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
اطلاعات بیشتری وجود ندارد
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