Determine the effect of warm foot bath on the mean neuropathy of elderly people with diabetes;
Determine the effect of warm foot bath on the mean score of fatigue in elderly people with diabetes;
Design
Two arm parallel group randomised trial with One Blind postoperative care and outcome assessment
Settings and conduct
Empirical study، the Diabetes Research Center of Yazd city.One-way blindness is done in participants and analyzers.
Participants/Inclusion and exclusion criteria
Significance of inclusion: People over 60 years of age referred to the Diabetes Research Center of Yazd, having diabetes and sensory neuropathy and earning a minimum score of 6 in the Michigan Questionnaire or 3 from the Michigan Examination Department, earning a minimum score of 4 in the Piper Fatigue Scale, Frequent and informed consent to participate in the study, lack of illness or conditions affecting neuropathy (cerebral stroke, multiple sclerosis, gout, Parkinson's, spinal cord injury, Guillain Barre, rheumatic disease with the approval of a neurologist, alcohol and smoking) ;
Exit criteria: Skin diseases such as eczema and any lesions in the legs and cognitive impairment and moderate to severe depression; Deep vein thrombosis, proven or suspected to deep vein thrombosis and varicose veins;
Intervention groups
1. No intervention in the control group
2. Perform 8 sessions of hot foot bathing for one day during the 2 weeks during the presence of the elderly in the center for 20 minutes immersion in both feet at 40 ± 2 ° C and determining the mean neuropathy and fatigue Intervention group samples were taken two weeks and one month later
Main outcome variables
neuropathy, fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171217037931N1
Registration date:2018-05-07, 1397/02/17
Registration timing:registered_while_recruiting
Last update:2018-05-07, 1397/02/17
Update count:0
Registration date
2018-05-07, 1397/02/17
Registrant information
Name
SEDIGHEH MOKHTARI HASAN ABAD
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3522 9466
Email address
s.mokhtari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-24, 1396/10/03
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of warm foot bath on neuropathy and fatigue in elderly patients with diabetes mellitus
Public title
Effect of warm foot bath on neuropathy and fatigue in diabetic elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People over 60 years of age referred to the Diabetes Research Center of Yazd
diabetes
sensory neuropathy, and earning a minimum score of 6 in the Michigan Questionnaire or 3 from the Michigan Examination Department
earning a minimum score of 4 in the Piper Fatigue Scale
lack of illness or conditions affecting neuropathy (stroke, multiple sclerosis, gout, Parkinson's, spinal cord injury, Guillain Barre, rheumatic disease approved by a neurologist, alcohol and smoking)
informed consent for Participate in the study
Exclusion criteria:
Diseases of the skin such as eczema and any lesions in the legs
cognitive impairment and moderate to severe depression
deep vein thrombosis, proven or suspected to deep vein thrombosis and varicose veins
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, random number table tool, individual randomization unit
Blinding (investigator's opinion)
Not blinded
Blinding description
Data analyzer is a one-way blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
NO.8917774894,Faculty of Nursing and Midwifery, Bou Ali Ave, Tayyasar Fallahi Blvd, Safayeh، Yazd Town
City
yazd
Province
Yazd
Postal code
8917774894
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.SSU.REC.1396.144
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08.21
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic nephropathy
2
Description of health condition studied
Sensory Neuropathy
ICD-10 code
E08.40
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Sensory neuropathy
Timepoint
Take the study 15 days and one month after the start
Method of measurement
Michigan questionnaire
2
Description
Fatigue
Timepoint
Take the study 15 days and one month after the start
Method of measurement
Piper Fatigue Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Foot warm bath, 8 sessions of immersion feet in water at a temperature of 42-38 ° C for 20 minutes
Category
Treatment - Other
2
Description
Control group: No intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Dr. Masoud Rahmanian
Street address
NO.8917693571,Honar Hall Ave, shahid sadoughi Blvd,Yazd Town
City
Yazd
Province
Yazd
Postal code
8917774894
Phone
+98 35 3728 0228
Fax
+98 35 3728 0216
Email
drc@ssu.ac.ir
Web page address
http://ssu.ac.ir/cms/index.php?id=1287
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Behnaz Anjzab
Street address
NO,8917693571,Faculty of Midwifery Nursing، Buali Ave,fallahi Blvd,Safaeiyeh, Yazd Town
City
Yazd
Province
Yazd
Postal code
8917774894
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
info@ssu.ac.ir
Web page address
http://www.ssu.ac.ir/cms/index.php?id=287
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Sedigheh Mokhtari Hasan abad
Position
Graduate Student, Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO.8917774894,Faculty of Nursing and Midwifery, Bou Ali Ave, Tayyasar Fallahi Blvd, Safayeh، Yazd Town
City
Yazd
Province
Yazd
Postal code
8917774894
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
S.MOKHTARI@SSU.AC.IR
Web page address
http://www.ssu.ac.ir/cms/index.php?id=287
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sedigheh Mokhtari Hasan Abad
Position
Graduate Student, Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO,8917774894,Faculty of Midwifery Nursing، Buali Ave, Fallahi timsar Blvd,Safaeiyeh، Yazd Town
City
Yazd
Province
Yazd
Postal code
8917774894
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
info@ssu.ac.ir
Web page address
http://www.ssu.ac.ir/cms/index.php?id=287
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sedigheh mokhtari hassan abad
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO.8917774894,Faculty of Nursing and Midwifery, Bou Ali Ave, Tayyasar Fallahi Blvd, Safayeh، Yazd Town
City
Yazd
Province
Yazd
Postal code
8917774894
Phone
+98 355229466
Email
s.mokhtari@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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 study protocol will be shared as an article.
Data analysis will be shared as an article after the end of the study.
The informed consent form will be sent by email to the requesting parties.
A clinical study report will be shared through the article.
The SPSS file is sent via email in the data sorting system.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will be available to researchers working in academic and academic institutions.
Under which criteria data/document could be used
Presenting / documenting studies in research centers and universities related to aging, complications of chronic diseases, diabetes, and thermotherapy to prevent further studies.
What processes are involved for a request to access data/document
Applicants will send their application by e-mail and within a maximum of one week the requested items will be sent.
Comments
This clinical study was conducted to determine the effect of warm foot bath on neuropathy and fatigue in elderly patients with diabetes referred to the Yazd Research Center. All parts of the study, except for the names of the participants, can be published.