Determination the effect of topical application of ginger on the severity of needle pain in arteriovenous fistula in hemodialysis patients
Design
A randomized controlled trial, with a control group, with parallel groups including 200 dialysis patients. Randomization was performed using the four-way blocking method and concealment in randomization is done by using envelopes in a matte package, with A and B code.
The data collector and analyzer not aware of the group allocation.
Settings and conduct
This clinical trial is performed in the dialysis units of Imam Hussein, Bahar and Khatamolanbia hospitals in Shahrood.
In this study, pain after needle insertion into arteriovenous fistula was measured after topical application of ginger at the fistula site in hemodialysis patients.
Due to the use of ginger ointment which has a smell, it is not possible to blind the participants and only the data collector and analyzer are not aware of the allocation of groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hemodialysis patients undergoing dialysis for at least 2 sessions per week; patients who have undergone fistula at least 3 months.
Exclusion criteria: history of allergy to ginger; use of painkillers 12 hours before venipuncture
Intervention groups
For the intervention group, 20 minutes before the venipuncture 5 ml of ginger ointment, with benzaline 1% brand, made by Notak Far Company of Tehran, is applied to the fistula at 5 x 5 cm.
In the control group, venipuncture is performed routinely without any ointment.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190825044608N1
Registration date:2019-10-12, 1398/07/20
Registration timing:registered_while_recruiting
Last update:2019-10-12, 1398/07/20
Update count:0
Registration date
2019-10-12, 1398/07/20
Registrant information
Name
Bita Koushki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 7424
Email address
koushki@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-06, 1398/07/14
Expected recruitment end date
2020-01-04, 1398/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The ٍEffect of Ginger on the Severity of Pain due to the entry of needle into the Arteriovenous Fistula in Dialysis Patients
Public title
The ٍEffect of Ginger on the Severity of Pain due to the entry of needle into the Arteriovenous Fistula in Dialysis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 to 65 years
Having complete vigilance
Hemodialysis patients undergoing dialysis at least 2 sessions per week.
Patients who have at least 3 months past their fistula.
Exclusion criteria:
Patient's Verbal and Mental Disabilities
Acute pain for any reason
Use painkiller 12 hours before venipuncture
A history of allergy to ginger
Drug addiction and painkillers
The presence of damaged skin at the desired position
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
The 4 - block method is used for randomization, . This is because the participants will gradually study, as well as the number of allocations to each group. The unit of randomization is individual. The random assignment sequence is obtained by the methodology consultant with the software. The qualifying patient is registered by the first host and the participants ' assignment to groups is also performed by the same person on the basis of the recorded model in the first stage. The random order of will is carried out secretly. That is, the number of 200 packets are generated in the Matilda package containing both A and B code. After obtaining conscious satisfaction and identifying that the person is involved in the study, the researcher took the intended envelope in the specified sequence and acted on the registered group in the envelope.
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 University of Medical Sciences,7th Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۷
Approval date
2019-08-25, 1398/06/03
Ethics committee reference number
IR.SHMU.REC.1398.052
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Pain
Timepoint
Immediately after needle insertion into the arteriovenous fistula
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
For the group (A), the group intervention 20 minutes before the veinpunctur of 5 mL of ginger Ointment With the brand name benzol in 1% Construction of Notekfar company Tehran by Applicator(5mL)took from within container from the dish to an area of 5 at 5 cm on used the point where the fistula. 30 seconds before the needle is inserted, again disinfect with piodine iodine. The pain of patients will be assessed and recorded immediately after veinpuncture by another person with VAS scale.
Category
Treatment - Drugs
2
Description
Control group: In control group (B) we use routine method and no solution is used. 30 seconds before the needle is inserted, again disinfect with piodine iodine. In order to prevent differences in the venous pattern and the cause of pain, all patients will be veinpuncture by one person and immediately by another person will be assessed and recorded using the VAS Visual Pain Scale.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein , Bahar and Khatamolanbia hospitals
Full name of responsible person
Bita Koushki
Street address
Shahroud University of Medical Sciences, 7th Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
koushki@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Shahroud University of Medical Sciences, 7th Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
pishgiri@yahoo.com
Web page address
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
Bita koushki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, 7th Tir Square, Shahroud
City
Shagroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۷
Phone
+98 23 3239 5054
Email
koushki@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahboobeh Khajeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, 7th Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۷
Phone
+98 23 3239 5054
Email
khajeh@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Bita Koushki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, 7th Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۷
Phone
+98 23 3239 5054
Email
koushki@shmu.ac.ir
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
Unidentifiable patient data are shared.
When the data will become available and for how long
Start access period 1 year after publishing the results
To whom data/document is available
Available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use of documentation for medical research is permitted.
From where data/document is obtainable
Bita Koushki
koushkib90@gmail.com
What processes are involved for a request to access data/document
Email your wishes to the email listed above and then receive the information within a week.