Comparison of the effect of light pressure stroking massage with olive oil and placebo on severity of restless legs syndrome in patients undergoing hemodialysis
Comparison of the effect of light pressure stroking massage with olive oil and placebo on severity of restless legs syndrome in patients undergoing hemodialysis
Design
In this research, 60 eligible patients referring to hemodialysis department of Qom Kamkar Arab Nia hospital were chosen. Then, patients were randomly divided into two control and intervention groups.Patients will be allocated to two equal groups of massage with olive oil and placebo using blocking randomization method.
Settings and conduct
This study will be conducted on hemodialysis department of Qom Kamkar Arab Nia hospital.Patients, assessor, and also analyzer will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having chronic renal insufficiency; having restless legs syndrome; undergoing regular and consecutive hemodialysis from at least 6 months ago; doing hemodialysis at least two times weekly.
Exclusion criteria: presence of open wound below the knee; having sensory and movement disorders in legs, and being unable to walking; having addiction and cigarette smoking; having anemia; having mental disorders, dementia, and mental retarders.
Intervention groups
Before the hemodialysis, both legs of patients will be irrigated and cleaned from below the knee with normal saline solution (0.9%), and then dried it with a non-sterile gaze. After one hour of hemodialysis, both legs will be messaged from below the knee to toes through light pressure stroking with olive oil or placebo. Intervention will do two times weekly until 3 weeks. International restless legs syndrome rating scale will be fulfilled in the first day and one week after the last intervention.
Main outcome variables
Severity of restless legs syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130803014251N7
Registration date:2017-12-13, 1396/09/22
Registration timing:prospective
Last update:2017-12-13, 1396/09/22
Update count:0
Registration date
2017-12-13, 1396/09/22
Registrant information
Name
MORTEZA NASIRI
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 2622 5292
Email address
nasiri.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of light pressure stroking massage with olive oil and placebo on severity of restless legs syndrome in patients undergoing hemodialysis
Public title
The effects of light pressure stroking massage with olive oil on severity of restless legs syndrome in patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 18-65 years old
Full consciousness and being able to read and write
Having chronic renal insufficiency;
Having restless leg syndrome
Undergoing regular and consecutive hemodialysis from at least 6 months ago
Doing hemodialysis at least two times weekly
Exclusion criteria:
Having history of allergy to herbal products
Presence of open wound below the knee
Having sensory and movement disorders in legs, and being unable to walking
Having addiction and cigarette smoking
Having anemia
Having mental disorders, dementia, and mental retarders
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated to groups using blocking randomization method.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients, assessor, and also analyzer will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
No, 83, No 4 Ave., Safashar Blvd
City
Qom
Province
Ghoum
Postal code
3769-87363
Approval date
2017-10-31, 1396/08/09
Ethics committee reference number
IR.MUQ.REC.1396.97
Health conditions studied
1
Description of health condition studied
Restless legs syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
Primary outcomes
1
Description
Severity of restless legs syndrome
Timepoint
First day of intervention and one week after the last intervention
Method of measurement
International restless legs syndrome rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After one hour of hemodialysis, both legs will be messaged from below the knee to toes through light pressure stroking with olive oil.
Category
Treatment - Other
2
Description
Control group: After one hour of hemodialysis, both legs will be messaged from below the knee to toes through light pressure stroking with placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom Kamkar-Arab-Nia hospital
Full name of responsible person
Morteza Nasiri
Street address
19 Dey St, Qom, Qom Province
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3771 3511
Email
mortezanasiri.or87@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qom University of Medical Sciences
Full name of responsible person
Dr Hossien Saghafi
Street address
No, 83, No 4 Ave., Safashar Blvd
City
Qom
Province
Ghoum
Postal code
3769-87363
Phone
+98 25 3285 4011
Email
saghafi.h@gmail.com
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, Qom 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
Ghoum University of Medical Sciences
Full name of responsible person
Morteza Nasiri
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardisan, Ghadir Blvd, Qom, Qom Province
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3320 9123
Email
mortezanasiri.or87@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Morteza Nasiri
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardisan, Ghadir Blvd, Qom, Qom Province
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3320 9123
Email
mortezanasiri.or87@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Morteza Nasiri
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardisan, Ghadir Blvd, Qom, Qom Province
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3320 9123
Email
mortezanasiri.or87@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only a part of patients demographical data and main outcomes will be shared.
When the data will become available and for how long
Six months after data publishing
To whom data/document is available
Data will be available only for researchers working on academic and university associations
Under which criteria data/document could be used
Mention of study name
Mention of authors name
From where data/document is obtainable
Morteza Nasiri: School of Paramedicine, Qom University of Medical Sciences, Qom, Iran
What processes are involved for a request to access data/document