Comparison of Damask Rose and lidocaine spray on fistula cannulation pain in the hemodialysis patient
Design
A randomised trial with two groups of intervention and a control group, community-based and pragmatic, with parallel groups
Settings and conduct
This study will be done on hemodialysis patients in hemodialyse ward in Imam Hossein hospital of Malayer. Participants will be randomly divided into three groups and before the cannulation, in the intervention group 1 damask Rose and in group 2 Lidocaine spray will be used. There will be no intervention in the control group. And In all three groups, the severity of pain associated with cannulation will be investigated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with the end-stage renal disease, Use fistula to perform hemodialysis.
Exclusion criteria: Sensitivity to topical anesthetic and herbal allergens, Dependence on analgesics drugs
Intervention groups
Intervention group 1: in the first session dialysis procedure and without any interference cannulation performed. At the second session for 5 minutes before the cannulation, the Damask Rose %10 is inhaled. Intervention group 2: The first session is like Group1. at the second session, 5 minutes before cannulation two puffs of spray lidocaine sprayed on the skin surface location. Control group: Both sessions are performed without any intervention.
Main outcome variables
the pain of fistula cannulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180115038377N2
Registration date:2018-06-27, 1397/04/06
Registration timing:registered_while_recruiting
Last update:2018-06-27, 1397/04/06
Update count:0
Registration date
2018-06-27, 1397/04/06
Registrant information
Name
shadi asgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3222 6958
Email address
sh.asgari@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-07-11, 1397/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Damask Rose and lidocaine spray on arteriovenous fistula cannulation pain in patients in the hemodialyse ward
Public title
Comparison of Damask Rose and lidocaine spray on arteriovenous fistula cannulation pain in patients in the hemodialyse ward
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Renal failure requires hemodialysis
Exclusion criteria:
Initiation of hemodialysis less than 3 months ago
verbal, mental and vision problems
History of mental illness
Addiction
Dependence on analgesic medicines
Sensitization to local anesthetics and herbal allergens
The ability to smell
Nasal fracture
nose surgery
Severe cold
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The classification blocking method will be used.In this way, patients will be classified according to age, gender, education level and duration of use of the fistula.And in each class, according to the random number table and the six-tier blocks, they are assigned to three groups.
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 Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Facing the Mardom Park, Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6571915457
Approval date
2018-05-14, 1397/02/24
Ethics committee reference number
IR.UMSHA.REC.1397.093
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
the pain of fistula cannulation
Timepoint
Immediately after the first session without intervention and immediately after the second session with intervention
Method of measurement
visual pain scale
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In the first session dialysis procedure and without any interference cannulation performed. At the second session, three drops of 10%Damask Rose on a cotton ball and the volunteer should be inhaled from the interval of 7 to 10 cm for a period of five minutes.
Category
Treatment - Drugs
2
Description
Second intervention group: In the first session dialysis procedure and without any interference cannulation performed. At the second session, 5 minutes before the cannulation, two puff of Lidocaine spray are sprayed 5 cm away from the surface of the target area.
Category
Treatment - Drugs
3
Description
Control group: Both sessions are performed routinely, without any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital in Malayer
Full name of responsible person
Shadi Asgari
Street address
Shahid Mirzayi Alley, Shohada Ave, Malayer town
City
Malayer
Province
Hamadan
Postal code
6571915457
Phone
+98 81 3222 6958
Email
umsha.asgari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamedan University of Medical Sciences, Facing the Mardom Park, Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Asgari
Position
Nursing instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Mirzayi Alley, Shohada Ave, Malayer Town
City
Malayer
Province
Hamadan
Postal code
6571915457
Phone
+98 81 3222 6958
Email
umsha.asgari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Asgari
Position
Nursing instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Mirzayi Alley, Shohada Ave, Malayer Town
City
Malayer
Province
Hamadan
Postal code
6571915457
Phone
+98 81 3222 6958
Email
umsha.asgari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Asgari
Position
Nursing instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Mirzayi Alley, Shohada Ave, Malayer Town
City
Malayer
Province
Hamadan
Postal code
6571915457
Phone
+98 81 3222 6958
Email
umsha.asgari@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