Comparison the effect of two methods of reflexology massage and stretching exercises on the severity of restless leg syndrome among patients undergoing Hemodialysis in selected Hospitals in Isfahan
The present study aimed to investigate the effect of two methods of reflexology and stretching exercises on the severity of restless leg syndrome among patients undergoing hemodialysis. This is a clinical trial. Among the patients undergoing hemodialysis in selected hospitals in Isfahan, 90 qualified patients (The hemodialysis clients that regularly came to these hospitals for treatment, Age between 18 – 65, 3 months past from starting hemodialysis for clients at least, Clients give positive answer to every four question of restlessness legs syndrome diagnostic questionnaire, Clients did not take any drugs that control of restless legs syndrome, Clients did not take any drugs that severity of restless legs syndrome and Absence of every infection, lesions or important complication in legs), diagnosed with restless leg syndrome through standard restless leg syndrome questionnaire, were randomly selected by random number table. They were assigned to reflexology, stretching exercises and control groups through random allocation. Reflexology and stretching exercises were conducted three times a week for 30-40 minutes for four straight weeks and the effect of these interventions on severity of restless legs syndrome have been studied.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040717159N1
Registration date:2014-05-23, 1393/03/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-23, 1393/03/02
Registrant information
Name
Sahrzad Khojandi Jazi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 5490
Email address
sh_khojandi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences Isfahan
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two methods of reflexology massage and stretching exercises on the severity of restless leg syndrome among patients undergoing Hemodialysis in selected Hospitals in Isfahan
Public title
Comparison the effect of reflexology and stretching exercises on the severity of restless leg syndrome among patients undergoing Hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:The hemodialysis clients that regularly came to these hospitals for treatment;Age between 18 - 65;3 months past from starting hemodialysis for clients at least;Hemodialysis was performed 3 times a week with sodium bicarbonate solution;Restlessness legs syndrome was not idiopathic or familial;Clients did not take any drugs that control the signs of restless legs syndrome;Clients did not take any drugs that exacerbate the restless legs syndrome;Clients did not use relaxation techniques;Clients did not swimming, cycling, getting massage or stretching sports;Clients give positive answer to every four question of restlessness legs syndrome diagnostic questionnaire;Absence of any intellectual or physical disability;Clients should completely conscious and able to hear and answer the questions truly;Absence of any type of infection, lesions or important complication in legs;Absence of orthopedic complications to do stretching exercises;Absence of peripheral neuropathy or vascular complications in lower limbs;Exclusion criteria:Disinclination in every level of study;Changing in times of hemodialysis during the study;Start treatment with drugs which control the signs of restless legs syndrome during the study;start to take drugs that exacerbates the signs of restless legs syndrome;Engendering infection, lesions or important complications in legs;Engendering legs orthopedic complications inhibit stretching exercises during the study;Engendering neuropathy or vascular complications in lower limbs during the study;The patient died
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
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjirib Street, Azadi Street, Isfahan
City
Isfahan
Postal code
Approval date
2013-09-16, 1392/06/25
Ethics committee reference number
11/2707/د
Health conditions studied
1
Description of health condition studied
Restless legs syndrome
ICD-10 code
G25.8
ICD-10 code description
Other specified extrapyramidal and movement disorders
Primary outcomes
1
Description
Restless legs syndrome severity
Timepoint
Before the intervention, immediately after intervention
Method of measurement
International restless leg syndrome questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study reflexology was done 12 sessions, 3 times a week and every session 40 minutes in first 2 hours of hemodialysis that clients have not changing in blood pressure. In every session we have 15 minutes general stimulus and 5 minutes specific stimulus for every leg.
Category
N/A
2
Description
Stretching exercise was done in 12 sessions, 3 times a week and 30 minutes in first 2 hours of hemodialysis that patient has not changing blood pressure. Every session include 10 minutes warming up then 15 minutes stretching exercise according to the protocol and after that 5 minutes cool down.
Category
N/A
3
Description
Control group got routine interventions. they got unspecific massage by their family or hospital accommodators.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Ali Shariati Hospital
Full name of responsible person
Fariba Taleghani
Street address
Shariati Street
City
Isfahan
2
Recruitment center
Name of recruitment center
Zahraye Marzieh Hospital
Full name of responsible person
Fariba Taleghani
Street address
Ghods square
City
Isfahan
3
Recruitment center
Name of recruitment center
Noor and Ali Asghar Hospital
Full name of responsible person
Fariba Taleghani
Street address
Hasht Behesht Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Hezarjirib Street, Azadi Street, Isfahan
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Shahrzad Khojandi Jazi
Position
MSc in Nursing Education
Other areas of specialty/work
Street address
College of Nursing and Midwifery, hezarjirib Street, Azadi Street
City
Isfahan
Postal code
Phone
+98 31 1335 7067
Fax
Email
shahrzad45@ymail.com; sh_khojandi@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Nahid Shahgholian
Position
masters
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Hezarjirib Street, Azadi Street
City
Isfahan
Postal code
Phone
+98 31 1792 2940
Fax
Email
shahgholian@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Nahid Shahgholian
Position
masters
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Hezarjirib Street, Azadi Street
City
Isfahan
Postal code
Phone
+98 31 1792 2940
Fax
Email
shahgholian@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)