Determining the effect of fistula cannulation in two scarred and non-scarred areas on pain intensity and bleeding in hemodialysis patients
Design
Clinical trial one group with crossover, 74 patients. Randomisation was carried out by random allocation software.
Settings and conduct
Patients from 4 selected hospitals of Yazd province, including Emma Jafar Sadegh hospital of Meybod city, Ziaei of Ardakan city, Shahid Rahnemoun and Shohadae_Kargar of Yazd city enter in the study. Intra-fistula cannulation will be performed once at the scar site and again at the non-scar site in the patients. The amount of pain as well as the amount of bleeding after removal of the needle from the fistula at the end of hemodialysis will be measured in each patient in both methods.
Participants/Inclusion and exclusion criteria
At least 3 months of history of hemodialysis through fistula; Be vigilant; Age over 18 years; No difficulty in accessing arteries; Lack of neuropathic disorders; Patients with peripheral vascular injuries
Intervention groups
The intervention is cross-sectional and the cannulation is done once at the scar site and the next time at the non-scar stage, and the amount of pain and bleeding will be assessed.
Main outcome variables
Mean score of pain due to cannulation; mean amount of bleeding due to cannulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210725051986N1
Registration date:2021-11-03, 1400/08/12
Registration timing:registered_while_recruiting
Last update:2021-11-03, 1400/08/12
Update count:0
Registration date
2021-11-03, 1400/08/12
Registrant information
Name
Taybeh Dehghani Firoozabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3233 0647
Email address
tay.dehghani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fistula cannulation in scarred and non-scarred areas on pain intensity and bleeding in hemodialysis patients
Public title
Effect of cannulation in scarred and non-scarred areas on pain intensity and bleeding in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 3 months of history of hemodialysis through fistula
Alertness
Age over 18 years
No difficulty in accessing blood vessels
Lack of neuropathy and patients with peripheral vascular injuries
Exclusion criteria:
Malignancy and severe infection
Patients with skin diseases in or around the fistula
Patients who need surgery due to fistula dysfunction
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
More than 1 sample in each individual
Number of samples in each individual:
2
For each sample, the needle is inserted once into the scar site and once into the non-scar site.
Randomization (investigator's opinion)
Randomized
Randomization description
The available sample (74 patients) is selected based on the inclusion criteria and after extracting the patients' names and referring to the project statistical consultant, they are assigned a three-digit code 001 to 074. Using Random allocation statistical software by simple randomization method and sequence 001 to 074 in a row, the samples are divided into two groups A and B. In group A, first cannulation is performed at the scar site and in group B, first non-scar cannulation is performed and in the next stage, the interventions are shifted.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Central Administration, Bahonar Sq., Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-09-08, 1399/06/18
Ethics committee reference number
IR.SSU.REC.1399.157
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for renal dialysis
Primary outcomes
1
Description
The average pain score on the visual analogue scale
Timepoint
After insertion of the needle into the fistula in both methods studied
Method of measurement
Visual Analogue Scale
2
Description
The amount of bleeding after the needle is removed from the fistula
Timepoint
After removal of the needle from the fistula in both methods studied
Method of measurement
Standard Future model scales with a sensitivity of 0.01 g
Secondary outcomes
1
Description
Patient preference for using the cannulation method
Timepoint
After interventions
Method of measurement
ًuestionnaire
Intervention groups
1
Description
Intervention group: 74 patients are cross-selected for intervention based on inclusion criteria. After extracting, the patients' names were coded and they were placed in one of the two study groups using random allocation software. Intravenous arterial needle No. 20 hemodialysis made by the company Medwayteb and is placed in the fistula at least from a distance of 5 cm from the fistula with an angle of 30 to 40 degrees while the diagonal part of the needle is high. This is done in the first session according to the random allocation to determine the priority in terms of placement in the scar or non-scar fistula and in the next session vice versa for each patient.
Category
Other
2
Description
Control group: The same interventions of the intervention group are performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Jafar Sadegh Hospital
Full name of responsible person
Tayebeh Dehghani Firouzabadi
Street address
Janbaz Sq., Basij Blvd.
City
Meybod
Province
Yazd
Postal code
8961977138
Phone
+98 35 3235 1200
Fax
+98 35 3235 1206
Email
Meybodhospital@gmail.com
2
Recruitment center
Name of recruitment center
Zeyaei Hospital
Full name of responsible person
Tayebeh Dehghani Firouzabadi
Street address
Azadi Squ., Moallem Blvd.
City
Ardakan
Province
Yazd
Postal code
895185993
Phone
+98 35 3152 2114
Email
ziaee_hospital@ssu.ac.ir
3
Recruitment center
Name of recruitment center
Shahid Rahnemoun Hospital
Full name of responsible person
Jamileh Delshad
Street address
Farrokhi st., Shahid Beheshti Sq.
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0001
Email
rahnamoon@ssu.ac.ir
4
Recruitment center
Name of recruitment center
Shohadaye Kargar Hospital
Full name of responsible person
Yousef Kargar
Street address
Namaz Sq., Modarres Blvd.
City
Yazd
Province
Yazd
Postal code
0000000000
Phone
+98 35 3182 2000
Email
shohadakargar.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mostafa Javadi
Street address
opposite the Infertility Center in the summer, BouAli Street, Safaiei Blvd.
City
Yazd
Province
Yazd
Postal code
00000000000
Phone
+98 35 3824 1751
Email
parastari@med.ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Taybeh Dehghani firoozabadi
Position
Master student of intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Naser Zarei Aly., Shahid Mirbagheri Str.
City
Meybod
Province
Yazd
Postal code
8961817955
Phone
+98 35 3824 1751
Email
Tay.dehghani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mostafa Javadi
Position
Phd of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sadoughi School of Nursing and Midwifery, in front of Infertility Center, Safaieh St., Bouali Blvd.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
javadinurse@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Taybeh Dehghani Firoozabadi
Position
Master student of intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
in front of Infertility Center, Safaieh St., Bouali Blv.
City
Yazd
Province
Yazd
Postal code
0000000000
Phone
+98 35 3824 1751
Email
Tay.Dehghani@gmail.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
Information will be published without the names of participants and hospitals. Confidentiality of personal information will be assured
When the data will become available and for how long
After the publication of the results and the final defense of the dissertation
To whom data/document is available
Supervisor, members of the faculty / university research committee
Under which criteria data/document could be used
Improving patient conditions and use for evidence-based care
From where data/document is obtainable
Dr. Mostafa Javadi
What processes are involved for a request to access data/document
Written request from the researcher or scientific organizations and the university