Goals of the study: Investigating the effect of ARNIGOL cream on pain intensity due to needles insertion in hemodialysis patients. Study design: Double - blind randomized clinical trial. The method of the study includes: Study population: The patients undergoing hemodialysis in the hospitals of Ali Ibn Abi Taleb at Rafsanjan city and Shafa at Kerman city.Inclusion criteria: Patients were included if they were receiving hemodialysis through arteriovenous fistula at least two times a week for three consecutive months, did not suffer from neuropathies or peripheral vascular problems, had no sign of inflammation at fistula site. Exclusion criteria are unsuccessful puncture at the first attempt and participants’ voluntary withdrawal from the study. Sample size: 71 subjects. Study Intervention: In this study intervention and control groups will conduct on one patient. In this regard for every hemodialysis patient two needles are needed(Arterial needle and venous needle) that insert consecutively(all of the needles will be of the same material and size) ,One puncture site was randomly allocated to the experiment and the other one to the placebo.Before needle insertion, the experiment and the placebo sites were treated for ten minutes with respectively five milliliters of Arnigol cream and vitamin A and D ointment, respectively. After inserting needles, pain intensity will be measured by Visual Analogue Scale (VAS). The patients and pain rater will blind on cream type.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112615965N8
Registration date:2017-04-20, 1396/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-20, 1396/01/31
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
Rafsanjan University of Medical Scienes
Expected recruitment start date
2016-11-26, 1395/09/06
Expected recruitment end date
2016-12-26, 1395/10/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Arnigol cream on pain associated with arteriovenous fistula puncture among patients receiving hemodialysis
Public title
The effect of Arnigol cream on pain intensity caused by needles in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients were included if they were receiving hemodialysis through arteriovenous fistula at least two times a week for three consecutive months, were fully conscious, aged eighteen or more, did not suffer from neuropathies or peripheral vascular problems, had no sign of inflammation at fistula site, received no topical analgesic at fistula site prior to the study intervention, and had no known allergy to Arnigol cream. Exclusion criteria: Unsuccessful puncture at the first attempt and participants’ voluntary withdrawal from the study
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
71
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
One puncture site randomly simple(flip the coin) will allocate to the experiment and the other one to the placebo.
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 Boulevard, Rafsanjan
City
Rafsanjan
Postal code
7717932777
Approval date
2016-01-09, 1394/10/19
Ethics committee reference number
IR.RUMS.REC.1394.166
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 entering needles
Method of measurement
Based on a numerical scale VAS
Secondary outcomes
empty
Intervention groups
1
Description
For every hemodialysis patient two needles are needed(Arterial needle and venous needle) that insert consecutively, One puncture site was randomly allocated to the experiment and the other one to the placebo.Before needle insertion, the experiment sites will treat for ten minutes with respectively five milliliters of Arnigol cream(the cream is produce of GOLDARU company and its 100 grams contain 5g ARNICA extract). After inserting needles, pain intensity will be measured.
Category
Treatment - Drugs
2
Description
And other needle as control site scrubbing by placebo (vitamin A and D ointment) as the same amount (0.5 cc) 10 minutes before insertion. After inserting needles, pain intensity will be measured.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital, Rafsanjan and Shafa, Kerman
Full name of responsible person
Dr.Majid Kazemi
Street address
Faculty of Nursing and midwifery, Rafsanjan
City
Rafsanjan
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 Boulevard, Rafsanjan
City
Rafsanjan
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
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
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
dr.kazemi.n@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Somayeh Nejadbagheri Zadeh
Position
MSc
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
s_nbagheri59@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)