The aim of this study was to determine the effect of Effleurage massage with sesame oil on hemodialysis patient's restless leg syndrome.This study is a randomized clinical trial that was done on chronic renal failure patients undergoing hemodialysis that were referred to the Hemodialysis wards of ziaei Hospital of ardakan city and emam jafar sadegh Hospital in meybod city in 2016. The sampling method was convenience.60 patients that had the inclusion criteria were chosen and then were randomly allocated to two groups consisting of 30 patients. The intervention group received leg and foot Effleurage massage with sesame oil for four weeks, twice a week, and each time for 10 minutes respectively. The Control group received usual care of hemodialysis patients. One week after the end of the study, the patients completed the study tools. The results were analyzed with the, chi square and t test in SPSS version 19.
Inclusion criteria:Chronic renal failure patients On Hemodialysis regularly For at Least6 months prior to Restless legs syndrome؛Regularly scheduled dialysis at least twice a week؛Ranging in age from 18 to 65 years؛Hb higher than 10 mg per deciliter
Exclusion criteria:Uncooperative patient or died during the study؛Allergy symptoms during the study؛Injury or accident during study treatment؛Start a new drug treatment intervention in the study by psychiatrists؛Aggravate RLS symptoms and the lack of control؛Addiction and substance abuse, lack of disease psychosis, dementia and mental retardation؛Movement disorders in legs؛There is an open wound below the knee to the foot.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111030815N1
Registration date:2017-03-16, 1395/12/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-16, 1395/12/26
Registrant information
Name
Heydar Kalantari
Name of organization / entity
Shahid Sadoughi Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 32244658
Email address
kalantari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences Yazd
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2016-12-19, 1395/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Effleurage massage With Sesame oil On Hemodialysis patient's
Restless leg syndrome
Public title
The Effect of Massage with sesame oil on Hemodialysis patient's leg pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Chronic renal failure patients On Hemodialysis regularly For at Least6 months prior to Restless legs syndrome؛Regularly scheduled dialysis at least twice a week؛Ranging in age from 18 to 65 years؛Hb higher than 10 mg per deciliter
Exclusion criteria:Uncooperative patient or died during the study؛Allergy symptoms during the study؛Injury or accident during study treatment؛Start a new drug treatment intervention in the study by psychiatrists؛Aggravate RLS symptoms and the lack of control؛Addiction and substance abuse, lack of disease psychosis, dementia and mental retardation؛Movement disorders in legs؛There is an open wound below the knee to the foot.
Age
From 77 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahid Sadoughi University of Medical Sciences Yazd
Street address
Yazd.Shahid Sadoughi University of Medical Sciences Yazd
City
ARDAKAN
Postal code
8944158318
Approval date
2016-02-19, 1394/11/30
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394.469
Health conditions studied
1
Description of health condition studied
Hemodialysis patient's
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis
Primary outcomes
1
Description
Restless leg syndrome
Timepoint
Baseline,First week,Second week,Third week,Forth week,One week after the end of the study
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Restless legs
Timepoint
Baseline,First week,Second week,Third week,Forth week,One week after the end of the study
Method of measurement
ًuestionnaire
Intervention groups
1
Description
This study is a randomized clinical trial that was done on chronic renal failure patients undergoing hemodialysis that were referred to the Hemodialysis wards of ziaei Hospital of ardakan city and emam jafar sadegh Hospital in meybod city. The sampling method was convenience.60 patients that had the inclusion criteria were chosen and then were randomly allocated to two groups consisting of 30 patients. The intervention group received leg and foot Effleurage massage with sesame oil for four weeks, twice a week, and each time for 10 minutes, one hour after the start of dialysis patients, at a rate of 30 to 60 cc respectively. One week after the end of the study, the patients completed the study tools. The results were analyzed with the , chi square and t test in SPSS version 19.
Category
Other
2
Description
The Control group received usual care of hemodialysis patients.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardakan Ziaei hospital
Full name of responsible person
Mr.Dehstani
Street address
Ziaei Hospital Of Ardakan
City
Ardakan
2
Recruitment center
Name of recruitment center
Emam jafar sadegh Hospital Of Meybod
Full name of responsible person
kalantari
Street address
Emam jafar sadegh Hospital Of Meybod
City
Meybod
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd, Iran
Full name of responsible person
Dr.Ghasemi
Street address
International Campus Yazd,Iran
City
Ardakan
Grant name
0
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences Yazd, Iran
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
Shahid Sadoughi University of Medical Sciences Yazd, Iran
Full name of responsible person
kalantari Heydar
Position
Msc Student in Adult Critical Care Nursing
Other areas of specialty/work
Street address
Ziaei hospital of Ardakan
City
Ardakan
Postal code
8951869916
Phone
+98 35 3152 2039
Fax
0
Email
Perances3499@yahoo.com
Web page address
0
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd, Iran
Full name of responsible person
Phd,Vaezi Ali akbar
Position
Phd,Assisstant Professor
Other areas of specialty/work
Street address
Department of Nursing,,School of Nursing &Midwifery,Street Bu Aliyazd
City
Yazd
Postal code
8916877443
Phone
+98 358241751
Fax
Email
vaeziali@ssu.ac.ir
Web page address
0
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd, Iran
Full name of responsible person
Heydar Kalantari
Position
Msc Student in Adult Critical Care Nursing
Other areas of specialty/work
Street address
Ziaei hospital of Ardakan
City
Ardakan
Postal code
8951869916
Phone
+98 35 3152 2039
Fax
0
Email
Perances3499@yahoo.com
Web page address
0
Sharing plan
Deidentified Individual Participant Data Set (IPD)