Study of the effect of foot reflexology on blood sugar and HbA1c levels in type II diabetic patients undergoing hemodialysis
Design
This double-blind study was conducted on 70 hemodialysis patients with diabetes. In this clinical trial, the subjects were randomly divided into two equal groups of 35 controls and intervention.
Settings and conduct
In order to investigate the effect of foot reflexology on blood glucose and glycosylated hemoglobin in Arak Hami's hemodialysis center, 70 patients were randomly divided into two groups of 35 subjects randomly. In this double blind, patient, and data analyst, there was no information about how people were placed in the two groups. For the intervention group, reflexology was performed for a period of three months during hemodialysis. Blood sugar was measured before and after dialysis for 3 months and glycosylated hemoglobin before and after 3 months after the intervention. In the intervention group, only blood sugar and glycosylated hemoglobin tests were performed as in the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Having written and informed consent
2- No diabetic foot ulcer or infection in massage areas.
3- At least 3 years from the start of diagnosis of diabetes.
4- Have a minimum age of 30 and a maximum of 70 years.
5. Lack of skin diseases such as yellow wounds and ...
Exclusion criteria:
1- Type 1 diabetes
2- History of participation in complementary therapies such as reflexology and ... up to six months ago
3- Having coagulation disorders
4. Unwillingness to continue cooperation
5-Mortality or Immigration
Intervention groups
The intervention group included 35 hemodialysis patients with type 2 diabetes, that Reflexology was performed for 3 months.
The control group included 35 patients who did not receive any intervention.
Main outcome variables
Blood sugar, HbA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190617043910N1
Registration date:2019-09-27, 1398/07/05
Registration timing:retrospective
Last update:2019-09-27, 1398/07/05
Update count:0
Registration date
2019-09-27, 1398/07/05
Registrant information
Name
Sima Zahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
s_zahedi20@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-03-01, 1396/12/10
Actual recruitment start date
2018-12-01, 1397/09/10
Actual recruitment end date
2019-03-01, 1397/12/10
Trial completion date
2019-03-01, 1397/12/10
Scientific title
Study of the Effect of Foot Reflexology in Patients with Type II Diabetes Undergoing Hemodialysis on Blood Sugar and HbA1C Level
Public title
The Effect of Foot Reflexology in Patients with Type II Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having written and informed consent.
No diabetic foot ulcer or infection in massage areas
At least 3 years from the start of diagnosis of diabetes.
Have a minimum age of 30 and a maximum of 70
At least 3 years after the diagnosis of Renal failure
Lack of skin diseases such as impetigo and ...
Exclusion criteria:
Type 1 diabetes
History of participation in complementary therapies such as massage, reflexology and ... up to six months ago
Having coagulation disorders such as thrombocytopenia, warfarin poisoning and ...
Unwillingness to continue cooperation
mortality or Immigration
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, simple randomization method was used to determine the control and intervention groups. In this way, 70 sheets were put inside a box, 35 of which were written I as intervention and the other 35 were written C as control. The box was then given to the patients to select one patient from each box with their eyes closed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this one-blind study, the data analyzer does not know which control group and which intervention. But participants in the research, the researcher, the interventionist, and those involved in the preparation of the proposal are fully aware of the control and intervention groups. Also, the Committee on Safety and Data Monitoring has no role in the present trial.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
sardasht- basij square
City
arak
Province
Markazi
Postal code
3819693345
Approval date
2018-01-21, 1396/11/01
Ethics committee reference number
IR.ARAKMU.REC.1396.274
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
IV
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
level of blood sugar
Timepoint
Measure of blood sugar levels before and after each intervention session, three times a week for three months
Method of measurement
Glucometer
2
Description
Glycated hemoglobin
Timepoint
Before and after the intervention
Method of measurement
blood sample with Elisa kit
Secondary outcomes
empty
Intervention groups
1
Description
70 participants were randomly divided into intervention and control groups. Intervention group: 35 patients with diabetes undergoing hemodialysis, undergoing foot reflexology for 10 minutes per foot for 3 months and 3 times per week at bedtime, in supine position, with pillow The head and one of the knees were placed in a gentle, normal environment at 20 to 24 ° C. Before the intervention, warm water was used to increase foot freshness. The towels were then dried with a towel and the odor-softening lotion was applied before the start of the reflection massage to relax the legs. Evaluation of blood glucose in two stages: 1- Before the intervention, 2- After the intervention with glucometer for three months and evaluation of glycosylated hemoglobin in two stages: 1- Before the intervention and 2- Three months after the intervention accepted.
Category
Treatment - Other
2
Description
Control group: 35 patients with diabetes were treated with hemodialysis for which no intervention or reflexology was performed, but routine blood glucose control treatments such as exercise, diet and medication regimens were continued as usual and blood glucose testing was continued. Glycated hemoglobin was used as the intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hami Hemodialysis Center
Full name of responsible person
Sima Zahedi
Street address
sardasht, basij square
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
s_zahedi20@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
sima zahedi
Street address
sardasht, basij square
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
s_zahedi20@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
sima zahedi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
sardasht, basij square
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
s_zahedi20@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
sima zahedi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
sardasht, basij square
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
s_zahedi20@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
sima zahedi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
sardasht, basij squqre
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
s_zahedi20@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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Unnamed participants' data includes demographic information, the primary and secondary outcome of sharing.
When the data will become available and for how long
Start access after publishing the article for 6 months
To whom data/document is available
Participants in the research project
Under which criteria data/document could be used
If the participants tend to be aware of the results of the study
From where data/document is obtainable
Corresponding Author
What processes are involved for a request to access data/document
he applicant can access the results two weeks after the request, with written request and contact with the Corresponding author after complying with the hierarchy.