Determining the effect of three methods of cold therapy on the pain intensity of vascular needles in hemodialysis patients
Design
Clinical practice with control group,Double blind, randomized
Settings and conduct
The place of the study is dialysis center of Ali ibn Abitaleb Hospital in Rafsanjan
Participants/Inclusion and exclusion criteria
Inclusion criteria: A history of at least three months of hemodialysis; Being conscious; Being at the age of 18 or more; Patients who are able to diagnose pain assessment; Willing to participate in the study.
Exclusion criteria: Any problem in vascular accessibility; Peripheral vascular disease; Unsuccessful puncture at the first attempt; Neuropathy disorders
Intervention groups
The research samples will participate three times in the research. During the hemodialysis, two vessels are taken from the patients. A place will be under the intervention and another place will be placed under the placebo treatment. There will be three interventions and three placebos in this study and in each session one intervention and its relevant placebo will be given to the patient. Therefore, three therapeutic interventions (Mini AIS Cooling Gel, Cold Spray and Ice Compounds) will be performed through three hemodialysis sessions.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015965N13
Registration date:2019-01-09, 1397/10/19
Registration timing:retrospective
Last update:2019-01-09, 1397/10/19
Update count:0
Registration date
2019-01-09, 1397/10/19
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment the effect of three methods of cold therapy on the pain intensity of vascular needling in patients undergoing hemodialysis
Public title
The effect of Cold Therapy on pain intensity caused by needles in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A history of at least three months of hemodialysis
Being conscious
Being at the age of 18 or more
Patients who are able to diagnose pain assessment
Willing to participate in the study
Exclusion criteria:
Any problem in vascular accessibility
Peripheral vascular disease
Unsuccessful puncture at the first attempt
Neuropathy disorders
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
By simple randomization method and through lottery, it is determined which intervention should be used in each session.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the participants in the study and the person evaluating the pain are blind to the intervention
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Approval date
2018-05-26, 1397/03/05
Ethics committee reference number
IR.RUMS.REC.1397.054
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
pain
Timepoint
Immediately after importing Needles
Method of measurement
Based on a numerical scale VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: at the entrance of the needle (venous or arterious), an ice pack with dimentions of 2 ˣ 2 ˣ 2 which put inside the glove will use for 3 minutes.
Category
Treatment - Drugs
2
Description
Control group: In the opposite site of intervention 1, a piece of wood with dimentions of 2 ˣ 2 ˣ 2 which put inside a glove will be used for 3 minutes.
Category
Treatment - Drugs
3
Description
Intervention group 2: at the entrance of the needle (venous or arterious), the cold spray (manufactured by Delta-Daroo Pharmaceutical Company ) will be sprayed from a distance of 25 cm for 2 seconds and cannulation will be done after 20 seconds.
Category
Treatment - Drugs
4
Description
Control group 2: In the opposite site of intervention 2, distilled water spray will be used in the same way as cold spray.
Category
Treatment - Drugs
5
Description
Intervention group 3: at the entrance of the needle (venous or arterious), 1 cc coolant gel (produced by Oran Arash company) will use and cannulation will done after 4 minutes.
Category
Treatment - Drugs
6
Description
Control group 3: In the opposite site of intervention 3, 1 cc lubricant gel will be used in the same way as coolant gel.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan Ali-ibn Abi-Talib Hospital
Full name of responsible person
Dr. Majid Kazemi
Street address
Parastar street
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
dr.kazemi.n@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Street address
Rafsanjan University of Medical Sciences,Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
dr.kazemi.n@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
phd
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences,Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
dr.kazemi.n@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
phd
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences,Imam Ali Blvd
City
rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
dr.kazemi.n@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
somayeh esmaili nasab
Position
MSc
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences,Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
esmailinasab95@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD