This study aims to determine the effects of progressive muscle relaxation on the intensity of restless leg syndrome (RLS) in hemodialysis patients. A total of 74 patients who visit Hasheminejad Hospital for hemodialysis will be randomly allocated to two groups (intervention and control). The main inclusion criteria will be age range of 18-65 years, willingness to participate (declared by signing the informed consent form), and self-reports of RLS confirmed by the physician. The major exclusion criteria will be patient death or their family’s disapproval of their participation. The intensity of RLS in the intervention and control groups will be compared before the application of the relaxation technique. The control group will receive routine care (provided in all similar therapeutic centers). In addition to receiving routine care, the intervention group will perform the progressive muscle relaxation twice daily (once during the day and once before going to bed) for a period of one month. Finally, the intensity of the RLS after the intervention will be compared to the values recorded before the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102824769N1
Registration date:2016-01-16, 1394/10/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-16, 1394/10/26
Registrant information
Name
Mahya Mousavi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4444 5994
Email address
moosavim92@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2016-01-06, 1394/10/16
Expected recruitment end date
2016-02-06, 1394/11/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Progressive Muscle Relaxation on the Intensity of Restless Leg Syndrome in Hemodialysis Patients, Hasheminejad Hospital, Tehran
Public title
Effects of Progressive Muscle Relaxation on the Intensity of Restless Leg Syndrome in Hemodialysis Patients, Hasheminejad Hospital, Tehran
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age range of 18-65 years; willingness to participate (declared by signing the informed consent form); self-reports of restless leg syndrome confirmed by the physician.
Exclusion criteria: patient death; patient family’s disapproval of their participation.
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:
74
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
Sabzevar University of Medical Sciences
Street address
Sabzevar, Mashhad, Khorasan Razavi
City
Sabzevar
Postal code
Approval date
2015-08-03, 1394/05/12
Ethics committee reference number
IR.MEDSAB.REC.1394.66
Health conditions studied
1
Description of health condition studied
Restless leg syndrome
ICD-10 code
R25-R29
ICD-10 code description
Symptoms and signs involving the nervous and musculoskeletal systems
Primary outcomes
1
Description
Intensity of restless leg syndrome
Timepoint
Before the intervention, after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care plus progressive muscle relaxation twice daily (once during the day and once before going to bed) for a period of one month.
Category
Other
2
Description
Control group: Routine care provided in all centers
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Unit, Hasheminejad Hospital
Full name of responsible person
Dr Shahrzad Osareh
Street address
Hasheminejad Hospital, Valinejad St., Vanak Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Najafi
Street address
Sabzevar, Mashhad, Khorasan Razavi
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mahya Mousavi
Position
MSc Student in Nursing
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Postal code
Phone
+98 26 3653 3938
Fax
Email
moosavim92@medsab.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Moosalreza Tadayonfar
Position
MSc in nursing, Faculty member
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Postal code
Phone
+98 51 4444 5994
Fax
+98 51 4444 5994
Email
tadayonfarm@medsab.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mahya Mousavi
Position
MSc Student in Nursing
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Postal code
Phone
+98 26 3653 3938
Fax
+98 51 4444 6070
Email
MoosaviM92@Medsab.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)