To assess the effectiveness of stretching exercises and leg massage on the severity of restless leg syndrome for hemodialysis patients
Design
Quasi experimental design with Two intervention groups : stretching exercises and leg massage, and one control group, and with 90 sample size with 30 for each of the three groups selected purposively was used to conduct a study that started from 10 October 2022 and ended in May 31 2023, while the data collection specifically started on January 1, 2023 and ended on March 14, 2023
Settings and conduct
Wasit Hemodialysis centers (Al-zahraa Teaching Hospital and Martyr Fairouz Hospital) and Thi-Qar dialysis centers (Al-Nasiriya General Hospital, Al-Refaai General Hospital, and Al-Hussein Teaching Hospital).
Participants/Inclusion and exclusion criteria
Hemodialysis Patients who are above 18 and without infection or injuries in the legs
Intervention groups
Stretching exercises and legs massage and control group
Main outcome variables
Severity of restless legs syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221121056569N1
Registration date:2023-08-19, 1402/05/28
Registration timing:retrospective
Last update:2023-08-19, 1402/05/28
Update count:0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
Samaa Aljasani
Name of organization / entity
The University of Baghdad
Country
Iraq
Phone
+964 782 564 1756
Email address
samaa.ali2102m@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-01, 1401/10/11
Expected recruitment end date
2023-03-14, 1401/12/23
Actual recruitment start date
2023-01-01, 1401/10/11
Actual recruitment end date
2023-03-14, 1401/12/23
Trial completion date
2023-03-14, 1401/12/23
Scientific title
Effectiveness of Stretching Exercises and Leg Massage on the Severity of Restless Legs Syndrome for Hemodialysis Patients
Public title
Effectiveness of Nonpharmacological interventions to Reduce the Severity of Restless Legs Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis Adults with restless legs syndrome who are above 18 years old
Without any other problems in the legs
Stable mental status
Exclusion criteria:
Patients with restless legs syndrome who are below 18 years old
Patients with infection or injuries in the leg
Unstable mental state
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Reasearch Ethical Approval committee at the College of Nursing
Street address
Bab Al-Muadum
City
Baghdad
Postal code
10001
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
2395
Health conditions studied
1
Description of health condition studied
Restless legs syndrome patients who have an urgent desire to move their legs in order to acquire slight relief
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
Primary outcomes
1
Description
Severity of restless legs syndrome
Timepoint
before intervention, and 1, 2 weeks after intervention
Method of measurement
International restless legs syndrome study group rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: this intervention group received pretest then stretching exercises three times a week and for two weeks then a posttest at the end of the first week and second posttest at the end of the second week
Category
Other
2
Description
Intervention group 2: this intervention group received pretest then leg massage three times a week then a first posttest at the end of the first week then a second posttest at the end of the second week.
Category
Other
3
Description
Control group: group 3: received no intervention
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
AL-Zahra Teaching Hospital
Full name of responsible person
samaa ali zhamis
Street address
alzahra
City
Wasit
Postal code
52001
Phone
+964 782 564 1756
Email
samaa.ali2102m@conursing.uobaghdad.edu.iq
Web page address
2
Recruitment center
Name of recruitment center
Martyr Fairouz Hospital
Full name of responsible person
Prof. Dr. Wissam Jabbar Qasim
Street address
Al-Hay
City
Wasit
Postal code
52001
Phone
+964 782 564 1756
Email
samaa.ali2102m@conursing.uobaghdad.edu.iq
3
Recruitment center
Name of recruitment center
AL-Refaai General Hospital
Full name of responsible person
samaa ali zhamis
Street address
Al-refaai
City
Thi-Qar
Postal code
64001
Phone
+964 782 564 1756
Email
samaa.ali2102m@conursing.uobaghdad.edu.iq
4
Recruitment center
Name of recruitment center
Al-Hussein Teaching Hospital
Full name of responsible person
samaa ali zhamis
Street address
Alnasriya
City
Thi-Qar
Postal code
64001
Phone
+964 782 564 1756
Email
samaa.ali2102m@conursing.uobaghdad.edu.iq
5
Recruitment center
Name of recruitment center
Al-Nasriya General Hospital
Full name of responsible person
samaa ali zhamis
Street address
Nasriya
City
Thi-Qar
Postal code
64001
Phone
+964 782 564 1756
Email
samaa.ali2102m@conursing.uobaghdad.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing/University of Baghdad
Full name of responsible person
Prof. Dr. Wissam Jabbar Qasim
Street address
Bab Al-Muadum
City
Baghdad
Postal code
10001
Phone
+964 782 564 1756
Email
samaa.ali2102m@conursing.uobaghdad.edu.iq
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
College of Nursing/University of Baghdad
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
College of Nursing/University of Baghdad
Full name of responsible person
Prof. Dr. Wissam Jabbar Qasim
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
30 street
City
Wasit
Province
alfalahiya
Postal code
52001
Phone
+964 782 564 1756
Email
samaa.ali2102m@conursing.uobaghdad.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Nursing/University of Baghdad
Full name of responsible person
Prof. Dr. Wissam Jabbar Qasim
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
30 street
City
Wasit
Province
alfalahiya
Postal code
52001
Phone
+964 782 564 1756
Email
samaa.ali2102m@conursing.uobaghdad.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
College of Nursing/University of Baghdad
Full name of responsible person
Prof. Dr. Wissam Jabbar Qasim
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
30 street
City
Wasit
Province
alfalahiya
Postal code
52001
Phone
+964 782 564 1756
Email
samaa.ali2102m@conursing.uobaghdad.edu.iq
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The researcher will share the primary outcomes for the effectiveness of stretching exercises and leg massage on the severity of restless legs syndrome in the form of tables
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis, and successfully publishing the manuscript, all the related files will become available for 6 months after publications
To whom data/document is available
Researchers
Under which criteria data/document could be used
it may be used after seeking the author's permission and acknowledging her contribution
From where data/document is obtainable
the official email of samaa ali which is (samaa.ali2102m@conursing.uobaghdad.edu.iq)
What processes are involved for a request to access data/document
Just mailing the author as the email will be in the published article