Comparison of rope ladders and regional cannulation methods on severity and fear of pain of patients undergoing hemodialysis
Design
Two-group parallel clinical trial with 70 patients
Settings and conduct
This two-group clinical trial that will be performed with the participation of 70 patients undergoing hemodialysis in Hamadan in 1400.In group A(rope ladder), Using a 16G needle at an angle of 20 to 45 degrees, at least 5 cm away from the anastomosis area, insert the arterial needle and insert the venous needle at a distance of at least 5 cm from the arterial needle into the appropriate vein. In the second session, the needle entry point is 0.5 to 1 cm away from the arterial and venous needles and cannulation is performed in the previous method for up to six sessions. In the group B(regional) of cannulation in the second to sixth time, the arterial and venous needle is fixed near the site of the first cannulation in the fistula area.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a venous arterial fistula suitable for regional cannulation and rope ladder, Age between 18 and 65 years, Have a history of at least 3 months of fistula hemodialysis
Exclusion criteria: Reluctance of the patient to continue attending the study, Kidney transplantation
Intervention groups
Intervention group A:The researcher uses the rope ladder convolution method for two weeks. Arterial cannulation and venous cannulation are performed three times a week, which are measured each time before and immediately after cannulation in patients with fear of pain and pain intensity.
Intervention group B: In this group, the researcher uses the regional cannulation method for two weeks. Arterial and venous cannulation is performed three times a week. Patients' fear of pain and pain intensity are measured each time before and immediately after cannulation.
Main outcome variables
pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N37
Registration date:2021-11-15, 1400/08/24
Registration timing:prospective
Last update:2021-11-15, 1400/08/24
Update count:0
Registration date
2021-11-15, 1400/08/24
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of rope ladder and regional cannulation methods on severity and fear of pain of patients undergoing hemodialysis
Public title
Comparison of rope ladder and regional cannulation methods on severity and fear of pain
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having a venous arterial fistula suitable for regional cannulation and rope ladder
Age between 18 and 65 years
Have a history of at least 3 months of fistula hemodialysis
Exclusion criteria:
Reluctance of the patient to continue attending the study
Kidney transplantation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2021-09-25, 1400/07/03
Ethics committee reference number
IR.UMSHA.REC.1400.498
Health conditions studied
1
Description of health condition studied
chronic kidney disease
ICD-10 code
I13.2
ICD-10 code description
Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease
Primary outcomes
1
Description
Intensity of pain
Timepoint
Immediately after the intervention
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: In this group(rope ladder),using a 16G needle at an angle of 20 to 45 degrees, at least 5 cm away from the anastomosis area and insert the arterial needle and insert the venous needle (16G) at a distance of at least 5 cm from the arterial needle into the appropriate vein. Immediately after cannulation, the pain intensity is measured and in the second hemodialysis session, using a ruler, 0.5 to 1 cm away from both the arterial needle and the venous needle using the ruler in the first session, and the cannulation is performed as before. The same process will be repeated in the third session. And in the second week of cannulation, the fourth session returns to the needle position of the first session, and also the fifth session to the second needle position and the sixth session to the third needle position until the cannulation is done six times.
Category
N/A
2
Description
Intervention group B: In this group(regional) Using a 16G needle with an angle of 20 to 45 degrees with a distance of at least 5 cm from the arterial needle anastomosis and a venous needle (16 G), a distance of five to eight cm is placed from the arterial needle and immediately after cannulation by providing The ruler is measured to the patient, which is scaled from zero to ten, the severity of the pain is measured and then the arterial and venous needle is fixed near the site of the first cannula in the fistula area.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Beesat hospital
Full name of responsible person
Seyed Reza Borzou
Street address
Shahid Beheshti Blvd., Besat hospital, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
borzou@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Reza Borzou
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
borzou@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Reza Borzou
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
borzou@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Paria Moradi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Paria.moradi810@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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