Determination of The effect of cold spray on venopuncture pain in hemodialysis patients .
Design
double blind, randomized Clinical trials
Settings and conduct
This study will be performed as a randomized clinical trial in 80 hemodialysis patients.,thirty seconds before the cannulation In the intervention group 2 puff of cold spray( Cramer brand) and in the control group 2 puff of distilled water will be sprayed.Then the severity of pain immediately after canulation is assessed by the visual analog scale of pain ( VAS) . Data will then be analyzed using SPSS software version 18 .
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Hemodialysis patients with AV fistula or graft access who are more than 18 year and Signed informed consent
Exclusion Criteria: . Sensitivity to alcoholic solutions; . Pregnancy; . Use of analgesics within 24 hours before cannulation; . Patient with mental problems and inability to complete the questionnaire and collaboration; Patients with unstable hemodynamics, .participation in another study. Skin lesion at the site of punctuation, . numbness of the limb with vascular access.
Intervention groups
The effect of cold spray on venopuncture pain in hemodialysis patients
Main outcome variables
pain intensify
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180108038262N1
Registration date:2018-07-01, 1397/04/10
Registration timing:registered_while_recruiting
Last update:2018-07-01, 1397/04/10
Update count:0
Registration date
2018-07-01, 1397/04/10
Registrant information
Name
Zahra Shafii
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2315 2013
Email address
shafii_zahra@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cold spray on venopuncture pain in hemodialysis patients
Public title
The effect of cold spray on reducing venopuncture pain in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis patients with AV fistula or graft access
age more than 18 year
Exclusion criteria:
unwillingness of patient to participate in study
hypersensitivity to alcoholic components and solutions
Pregnancy
Use of analgesics within 24 hours before cannulation
Patient with mental problems and inability to complete the questionnaire and unable to collaborate
Patients with unstable hemodynamics
participation in another study
Skin lesion at the site of punctuation
numbness of the limb with vascular access
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned to one of the two intervention and comparison groups using the Random allocation Version 1.2 software. In the intervention group, cold spray and in the comparison group, distilled water will be used , and the nurse and patient are not aware of spray type. allocation Concealment is done by using central randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
In our study patients,health care providers and investigator will be blinded
Placebo
Used
Assignment
Parallel
Other design features
none
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Rajaee Cardiovascular Research and Treatment Center
Street address
Shahid Rajaee Cardiovascular Research and Treatment Center
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2017-10-25, 1396/08/03
Ethics committee reference number
RHC.AC.IR.REC.1396.43
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
venopuncture pain
Timepoint
at time of intervention
Method of measurement
VAS pain evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Two puff of cold spray will be sprayed on the site of cannulation and after 30 second cannulation will be done
Category
Treatment - Other
2
Description
Control group: Two puff of distilled water will be sprayed on the site of cannulation and after 30 second cannulation will be done
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaee Cardiology Training Center
Full name of responsible person
Zahra Shafii
Street address
Shaheed Rajaei Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection Tehran Iran
City
Trhran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
shafii_zahra@yahoo.com
2
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Nashmin Abdi Bastami
Street address
Emam Hossein Hosp. - Madani St. - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
123456789
Phone
+98 21 23921
Email
davoodihedayat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shaheed Rajaei Cardiovascular Medical And Research Center
Full name of responsible person
Zahra Shafii
Street address
Shaheed Rajaei Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
Shafii_zahra@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaheed Rajaei Cardiovascular Medical And Research Center
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
Shaheed Rajaei Cardiovascular Medical and Research Center
Full name of responsible person
Zahra Shafii
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shaheed Rajaei Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 23921021
Email
Shafii_zahra@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Rajaei Cardiovascular Medical and Research Center
Full name of responsible person
Zahra Shafii
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shaheed Rajaei Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
shafii_zahra@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Rajaei Cardiovascular Medical And Research Center
Full name of responsible person
Zahra Shafii
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shaheed Rajaei Cardiovascular Medical And Research Center, Valiasr Ave, Niayesh Intersection, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
Shafii_zahra@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
I have not decided yet - its release plan is still unclear
When the data will become available and for how long
I have not decided yet - its release plan is still unclear
To whom data/document is available
I have not decided yet - its release plan is still unclear
Under which criteria data/document could be used
I have not decided yet - its release plan is still unclear
From where data/document is obtainable
I have not decided yet - its release plan is still unclear
What processes are involved for a request to access data/document
I have not decided yet - its release plan is still unclear