Restless legs syndrome is a common neurological disorder consisting of an uncomfortable Sensation in one’s legs and irresistible urge or desire to move them. This study carries to determine the effect of massage and vibration on severity of symptoms of Restless legs syndrome and quality of sleep in hemodialysis patients. Patients with chronic renal failure undergoing at least 3 months dialysis and normal vasoskeletoneurological status include and comatose patients with catabolic disorders and drugs using history exclude. This randomized clinical trial will be conduct on 80 patients with Restless legs syndrome through cross over design in Hemodialysis wards of Yazd province by applying vibration and massage on patient legs for 12 sessions. We hope to improve Restless legs syndrome symptoms and sleep quality of hemodialysis patients by our interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022826814N1
Registration date:2016-07-06, 1395/04/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-06, 1395/04/16
Registrant information
Name
Somaye Azimpour
Name of organization / entity
Rafsanjan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 936 328 1502
Email address
s.hosseini@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsenjan University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vibration and massage on symptoms of RLS and quality of sleep in heamodialese patients
Public title
The effect of vibration and massage on symptoms of RLS and quality of sleep in heamodialese patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: affliction with chronic renal failure with at least 3 months of hemodialysis the presence of restless leg syndrome; having a normal neurologic and vascularand coagulate condition; lack of musculo-skeletal disorders; Lack of wounds and infections and skin disease and limb fracture;
Be able to participate in the research and collaboration
Exclusion criteria: patients with catabolic processes; unconsciousness; taking of analgesics; tranquilizers; narcotics and psychiatric drugs; skin lesions; lack of cooperation
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Science
Street address
Nursing and Midwifery Faculty
City
Rafsanjan
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
ir.rums.rec.1394.193
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
z49.0
ICD-10 code description
preparatory care for dialysiis
Primary outcomes
1
Description
Symptoms severity of Restless Leg Syndrome
Timepoint
One month after interventions
Method of measurement
Restless Leg Syndrome Questionnaires
Secondary outcomes
1
Description
Quality of Sleep
Timepoint
One Month after Interventions
Method of measurement
Petersburg Sleep Quality Questionnaire
Intervention groups
1
Description
vibration for 12 sessions on both shins and calves, 10minutes each time
Intervention category
Category
Other
2
Description
massage for 12 sessions on both shins and calves, 10minutes each time
Intervention category
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Jafar Sadeq Hospital in Meybod, Ziyaee Hospital in Ardakan, and Shahid Rahnemoon Hospital in Ya
Full name of responsible person
Somayeh Azimpour
Street address
Ardakan, Meybod, Yazd Hospital
City
Ardakan, Meybod, Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Hamid Hakimi
Street address
Rafsanjan, University of Medical Sciences
City
Rafsanjan
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, Rafsanjan 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
Rafsanjan Nursing and Midwifery College
Full name of responsible person
Somayeh Azimpour
Position
Msn in Critical Care Nursing
Other areas of specialty/work
Street address
Kerman, Rafsanjan
City
Ardakan
Postal code
8951933861
Phone
+98 35 3222 3209
Fax
Email
Somayeh.azimpour.pn@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Habibolla Hosseini
Position
Phd In Nursing
Other areas of specialty/work
Street address
Kerman, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 913 191 7915
Fax
Email
S.hosseini@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan Nursing and Midwifery College
Full name of responsible person
Somayeh Azimpour
Position
Msn in Critical Care Nursing
Other areas of specialty/work
Street address
Kerman, Rafsanjan
City
Ardakan
Postal code
8951933861
Phone
+98 35 3222 3209
Fax
Email
somayeh.azimpour.pn@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)