The purpose of this study is comparsion the effect of lidocaine gel 2% and hugo point ice massage on pain intensity of arteriovenous fistula puncture in heamodialysis patients.This study in patient treated hemodialys by arteriovenous fistula in fatemeh zahra and emam khomeiny hospital in sari. This study is a randomized clinical trial in which 74 patients heamodialysis randomly allocated to two groups of experiment to 2% lidocaine gel and experiment hugo point ice massage. Inclusion criteria: no pain whole body before insert of needle in to fistule exclusion criteria؛ no disease of preferal vascular and neuropathy؛ no known history of depression؛ starting hemodialysis for at least 3 months. Exclusion criteria: known allergies or sensitivities to lidocaine gel 2%؛ need to try for more of once؛ cognitive disorders؛ drug abuse 3 h before insert of needle in to fistule. First pain intersity of puncture measure without any intervention after needle insertion in arteriovenous fistula.then, during the next session hemodialys in the intervention group lidocaine gel, gel the amount 2 gr to extent 5 cm2, 12 minute befor AVF puncture was applied. during the next session hemodialys at group hugo point ice massege with ice cubes 2*2*2 cm2 at the 10 minute before arteriovenous fistula puncture massage on rotating web hugo (web between the numb and in index finger af hand) not having the AV fistule. pain degree during arterovenous fistula puncture was measured whith using a subjective pain scale (visual analogue scale).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508317494N15
Registration date:2015-10-13, 1394/07/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-13, 1394/07/21
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Mazandaran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effect of hugo point ice massage with 2% lidocaine gel on puncture- relted pain of fistula in hemodialysis patients.
Public title
The comparison of effect of hugo point ice massage with 2% lidocaine gel on puncture- relted pain of fistula in hemodialysis patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: no pain whole body before insert of needle in to fistule exclusion criteria؛ age>18 no disease of preferal vascular and neuropathy؛ no known history of depression؛ capable oral and visual relation؛ oriented؛ starting hemodialysis for at least 3 months.
Exclusion criteria: known allergies or sensitivities to lidocaine gel 2%؛ need to try for more of once؛ cognitive disorders؛ skin problems in the areaof massage؛ drug abuse 3 h before insert of needle in to fistule.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this randomized study, 37 patients with the software Rand between function Excel randomly were assigned to two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical
Street address
Ethics Committee of Mazandaran University of Medical,Vice chancellor for research, Moalem square, Sari, Mazandaran,Iran.
City
Sari
Postal code
4816715793
Approval date
2015-09-06, 1394/06/15
Ethics committee reference number
IR.MAZUMS.REC.94-1736
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Pain
Timepoint
before intervention and after every intervention
Method of measurement
Visual analoug scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: First patients hemodialys in the intervention group lidocaine gel complete pain visual analog scale and pain intensity evaluate and record by patients immediately after cannulation without any intervention on visual analogue scal During next session a hemodialys in group all patients receive lidocaine gel 2% 12 minute before AVF puncture in area of 5 cm2 amount 2 gr at the designated site no cover is placing at the designated site then gel remove and the skin disinfect before venopuncture and pain intensity of needle insertion evaluate and record by patients immediately after cannulation on visul analogue scale.
Category
Treatment - Drugs
2
Description
Intervention group 2: patients hemodialys in the intervention group hugo point ice mssege complete pain visual analog scale and pain intensity evaluate and record by patients immediately after cannulation without any intervention on visual analogue scal During next session hemodialys in group all patients the next session of hemodialys received ice massage on rotating at the 10 minute before arteriovenous fistula puncture (cold application 2*2*2 was done with ice cubes wrapped in gloves on the web between the thumb and index finger of the hand not having the AV fistula (hugo) massage during the injection lasts about 2 minutes, pain degree during arterio- venous fistula puncture was measured with using a subjective pain scale (Visual analogue scale).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh zahra hospital
Full name of responsible person
Dr Masoumeh Bagheri- Nesami
Street address
Mazandaran University of Medical Sciences, three- way joibar, highway bsij, Imam square, Sari, Mazandaran, Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Mazandaran University of Medical Sciences.
Full name of responsible person
Dr Ahmad Ali Enayeti
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Square, Sari, Iran.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Mazandaran 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
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr masumeh Bagheri Nesami
Position
PHD/ faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, three- way joibar, highway Basij, Imam square, Sari, Mazandaran,Iran.
City
Sari
Postal code
4816715793
Phone
+98 11 3336 7551
Fax
Email
anna3043@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
PHD/faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences,three way joibar,highway Basij,Imam square, Sari,Mazandaran,Iran.
City
Sari
Postal code
4816715793
Phone
+98 11 3336 7551
Fax
Email
anna3043@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)