The effect of local heat on restless legs syndrome and extreme fatigue in nurses working in intensive care units
Design
After determining the patients with restless legs syndrome, they will be assigned to groups A (test group) and B (control group) using quadruple blocks. The researcher will be treated with a warm water bag for 12 weeks in 12 sessions. After the intervention, the post-test (completing Restless legs Syndrome and Fatigue Questionnaire) will be performed.
Settings and conduct
The study population will be comprised of nurses working in intensive care units.
The nurses participating in the study will be randomly selected and divided into two groups of experimental and control. The intervention of the experimental group will be done for 4 weeks in 12 sessions. Due to the nature of the study it is not possible to be blinded.
Participants/Inclusion and exclusion criteria
Entry requirements :
Having at least one year of work experience
Undergraduate degree
Restless leg syndrome
Physicians working in intensive care units Exit conditions:
Taking medication and supplements
People taking painkillers and opiates within 72 hours before the study Consumers of psychotropic drugs
Neuromuscular disorders and arthritis
Pregnant women
Wounds and redness of the limbs
Heat sensitivity
Vascular diseases and diabetes
Intervention groups
The intervention will last for 4 weeks in 12 sessions. The hot water bag is placed intermittently under both legs of the nurses.
Main outcome variables
The variables of this study include restless legs syndrome and fatigue. For this purpose, demographic questionnaire, international standard questionnaire for standing legs syndrome and smeth fatigue questionnaire (MFI) will be provided to nurses from intensive care unit.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190723044316N1
Registration date:2019-10-10, 1398/07/18
Registration timing:prospective
Last update:2019-10-10, 1398/07/18
Update count:0
Registration date
2019-10-10, 1398/07/18
Registrant information
Name
maryam ameri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3223 3277
Email address
maryam19_2006@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local heat on restless legs syndrome and excessive fatigue in nurses working in the intensive care unit
Public title
effect of local heat on restless legs syndrome and excessive fatigue in nurses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a year of experience
Undergraduate degree
Restless leg syndrome
Physicians working in intensive care units
Exclusion criteria:
Taking Medication and Supplements
People taking painkillers and opiates within 72 hours before the study
Consumers of psychotropic drugs
Neuromuscular disorders and arthritis
Pregnant women
Wounds and redness of the limbs
Heat sensitivity
Vascular diseases and diabetes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the patients with restless legs syndrome, they will be assigned to groups A (test group) and B (control group) using quadruple blocks.
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 Shahroud University of Medical Sciences
Street address
Shahroud - Haft Tir Square - Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2019-09-30, 1398/07/08
Ethics committee reference number
IR.SHMU.REC.1398.079
Health conditions studied
1
Description of health condition studied
Restless leg syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
2
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
One of the variables in this study is restless legs syndrome. To this end, the International Standard Questionnaire for Restless Legs Syndrome will be provided to nurses by intensive care unit.
Timepoint
The intervention of the experimental group will be done for 4 weeks in 12 sessions
Method of measurement
The intervention of the experimental group will be done for 4 weeks in 12 sessions after the end of the intervention the post-test will be re-tested and again the questionnaires will be completed by the test and control group and the results will be compared with the previous results.
2
Description
One of the variables of this study is excessive fatigue and for this purpose Smyths Fatigue Inventory (MFI) will be provided to the nurses of intensive care units.
Timepoint
The intervention of the experimental group will be done for 4 weeks in 12 sessions
Method of measurement
The intervention of the experimental group will be done for 4 weeks in 12 sessions after the end of the intervention the post-test will be re-tested and again the questionnaires will be completed by the test and control group and the results will be compared with the previous results.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention of the experimental group will be conducted for 4 weeks in 12 sessions. After the end of the intervention the post-test will be taken and the questionnaires will be completed again by both groups and the results will be compared with the previous results. The hot water bag will be 40-43 ° C which is 1.3 to 2.3 It should be filled with warm water bags (for each nurse separate bag depending on the size of the body to the extent that it covers the surface of each foot) under the legs of the alternate nurse (because this syndrome occurs at night, Whether or not to do the shift by the person studied). The duration of bag usage will be 20 minutes based on the book of Nursing Principles and Techniques.
Category
Treatment - Devices
2
Description
Control group: Training is given only to the experimental group and no intervention is performed on the control group. After the intervention, the post-test group will receive post-test and again the questionnaires will be completed by both groups and the results will be compared with the previous results.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital - Spring Hospital - Khatam Al Anbia Hospital - Red Crescent Dialysis Center
Full name of responsible person
Maryam Ameri
Street address
Shahroud - Haft Tir Square - Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
maryam19_2006@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
Shahroud - Haft Tir Square – Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
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
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Ameri
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahroud - Haft Tir Square - Shahroud University of Medical Sciences
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
Email
maryam19_2006@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Reza Khatibi
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
sharrifi44_r@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Ameri
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahroud - Haft Tir Square - Shahroud University of Medical Sciences
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
Email
maryam19_2006@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
They will be made available with the consent of the University of Medical Sciences if the journal requires the participants' data file.
When the data will become available and for how long
three months
To whom data/document is available
Publicly available
Under which criteria data/document could be used
Data is only available for research projects or theses approved by medical universities throughout the country and only by providing a code of ethics and IRCT code.
From where data/document is obtainable
Study Guiding Professor
What processes are involved for a request to access data/document
E-mail the study guide with the ethics code and IRCT code.