The survey of the impact of infrared light therapy based on acupuncture points on the severity of restless leg syndrome in patients undergoing hemodialysis
The aim of the study was to determine the impact of infrared light therapy based on acupuncture points on the severity of restless leg syndrome in the hemodialysis patients. The design of this study is a randomized clinical trial. The inclusion criteria: informed consent for participation in the study; suffering from restless leg syndrome and the age range of 18 to 65 years. The exclusion criteria: failure to take part in the light therapy sessions in more than three sessions; recent use of restless leg syndrome drugs. The research sample size consists of 60 patients undergoing hemodialysis who are suffering from restless leg syndrome (intervention group 30, control group 30) and they are undergoing hemodialysis in Imam Reza hospital in Kermanshah city in 2017. The intervention in this study is using the infrared light on the acupuncture points for two minutes and during 12 sessions (three times a week). There is no intervention in the control group. After the intervention sessions, the restless leg syndrome is measured using the standard questionnaire of the restless leg syndrome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112727779N3
Registration date:2017-09-16, 1396/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-16, 1396/06/25
Registrant information
Name
Mohammad Mehdi Mohammadi
Name of organization / entity
Kermanshah University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 83 3836 1129
Email address
mm.mohammadi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of the impact of infrared light therapy based on acupuncture points on the severity of restless leg syndrome in patients undergoing hemodialysis
Public title
The impact of infrared light therapy in acupuncture points on the severity of restless leg syndrome in patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria: Informed consent for participation in the study; suffering from restless leg syndrome; the age range of 18 to 65 years.
Exclusion criteria: Unwillingness to continue participating in the study; failure to take part in the light therapy sessions in more than three sessions; recent use of restless leg syndrome drugs; kidney transplant; immigration or death.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
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
Using sealed envelope to randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah, Shahid Beheshti street, Building No. 2
City
Kermanshah
Postal code
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
KUMS.REC.1396.191
Health conditions studied
1
Description of health condition studied
Restless leg syndrome
ICD-10 code
G25.8
ICD-10 code description
Other specified extrapyramidal and movement disorders
Primary outcomes
1
Description
The severity of restless leg syndrome
Timepoint
Before the intervention, two weeks after the intervention, four weeks after the intervention, two weeks after the end of the intervention
Method of measurement
The standard questionnaire of the restless leg syndrome
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: The intervention in this study is using the infrared light in the acupuncture points for two minutes and during 12 sessions (three times a week).
Category
Rehabilitation
2
Description
The control group: There is no intervention in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohammad Mehdi Mohammadi
Street address
Imam Reza hospital, Baghe abrisham
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Building No. 2, Shahid Beheshti street, Kermanshah
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Mohammadi
Position
MSc in Nursing
Other areas of specialty/work
Street address
Building No. 2, Shahid Beheshti street, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3836 1129
Fax
Email
mehdi20.mohamadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Mohammadi
Position
MSc in nursing
Other areas of specialty/work
Street address
Building No. 2, Shahid Beheshti street, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3836 1129
Fax
Email
mehdi20.mohamadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Mohammadi
Position
MSc in nursing
Other areas of specialty/work
Street address
Building No. 2, Shahid Beheshti street, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3836 1129
Fax
Email
mehdi20.mohamadi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)