The purpose of this study is comparison of the effect of Glycerin oil and Lavender oil massage on Hemodialysis patient's restless leg syndrome. This study is randomized Clinical trial with control group that is done in two dialysis centers. The study population consisted of patients with chronic renal failure undergoing Hemodialysis in Hemodialysis ward of Akhavan Hospital in Kashan city and Kamkar Hospital in Qom city, Iran. Inclusion criteria: age between 18 - 65 years old; hemodialysis treatment for at least 6 months; regular dialysis at least twice a week; confirmation restless leg syndrome by standard questionnaire; Hemoglobin ≥ 10 mg/dl; no history of allergies to plants; no open wound leg and foot; no addiction and drug abuse; lack of psychosis disease, dementia and mental retardation; no leg sensory and motor disorders. Exclusion criteria: allergic symptoms during the study; organ injury or accident during the study; new drug therapy with intervention in studies. Sample volume is 90 patients. Patients entered in the study randomly allocated into 3 groups consisting of 2 intervention groups and 1 control group. The study period is 3 weeks. The intervention group1 consisted of 30 patients that receive legs simple massage by Glycerin oil. It will be done twice a week for 3 weeks and each session lasts for half an hour during dialysis. The intervention group2 consisted of 30 patients that receive legs simple massage by 60-30cc Lavender oil 1.5%. It will be done twice a week for 3 weeks and each session lasts for half an hour during dialysis. The control group consisted of 30 patients that they receive routine care of dialysis. Before intervention and 3 episode post intervention with intervals of one week, severity of restless leg syndrome in the intervention groups and control group will be determined and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102214086N5
Registration date:2014-11-08, 1393/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-08, 1393/08/17
Registrant information
Name
Mohammad Aghajani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2001
Email address
aghajani_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research، Kashan University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Glycerine oil and Lavender oil massage on Hemodialysis patient's restless leg syndrome
Public title
The effect of simple massage with Lavender oil on restless leg syndrome in Hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 - 65 years old; hemodialysis treatment for at least 6 months; regular dialysis at least twice a week; confirmation restless leg syndrom by standard questionnaire; Hemoglobin ≥ 10 mg/dl; no history of allergies to plants; no open wound leg and foot; no addiction and drug abuse; lack of psychosis disease, dementia and mental retardation; no leg sensory and motor disorders.
Exclusion criteria: allergic symptoms during the study;
organ injury or accident during the study; new drug therapy with intervention in studies.
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:
90
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
Kashan University of medical Science
Street address
Ghotbe Ravadi, Kashan
City
Kashan
Postal code
Approval date
2014-10-07, 1393/07/15
Ethics committee reference number
93139
Health conditions studied
1
Description of health condition studied
Restless leg syndrome
ICD-10 code
Other diso
ICD-10 code description
G99
Primary outcomes
1
Description
Restless leg syndrome severity
Timepoint
Pre intervention and 3 episode post intervention with Intervals of one week
Method of measurement
international standard restless leg syndrome questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group1 consisted of 30 patients that They receive legs simple massage by glycerin oil. Glycerin Oil in this group of patients is only for convenience massage. It done twice a week for 3 weeks and each session lasts for half an hour.
Category
Treatment - Drugs
2
Description
The intervention group2 consisted of 30 patients that They receive legs simple massage by 60-30cc Lavender oil 1.5%. It done twice a week for 3 weeks and each session lasts for half an hour.
Category
Treatment - Drugs
3
Description
The control group consisted of 30 patients that They receive routine care of dialysis
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan Hospital
Full name of responsible person
Seyed Hossein Hashemy
Street address
City
Kashan
2
Recruitment center
Name of recruitment center
Kamkar Hospital
Full name of responsible person
Seyed Hossein Hashemy
Street address
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research & Technology, Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Ghotbe Ravandi, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research & Technology, Kashan University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Seyed Hossein Hashemy
Position
Ms Student of Critical Nursing Care
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Km 3 pole Ravandi,Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
hashemy1391@ yahoo. com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Muhammad Aqhajani
Position
Master
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Km 3 pole Ravandi,Kashan
City
Kashan
Postal code
Phone
+98 36115550021
Fax
Email
aghajani1362@yahoo.com; aghajani_m@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
Masters
Other areas of specialty/work
Street address
Quotbe Ravandi Bul, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
aghajani_m@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)