Ninety patients were randomly assigned to either the li4ice stimulation (n=30) and two control groups (n=30) who were undergoing hemodialysis by using AVF. We were randomly assigned to experimental and control groups using a randomization table. The experimental group received li4 ice massage at the 10 minute before arteriovenous fistula puncture: (Cold application 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 (hoku) (contra lateral arm), the control group 1, received massage in wrist of contra lateral arm and the second control group received li4 massage. Pain degree during arterio-venous fistula puncture was measured with using a subjective pain scale (visual analogue scale) in first day without intervention. In the second day after 10 minute intervention in study groups, pain degree was measured again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106136786N1
Registration date:2011-06-21, 1390/03/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-21, 1390/03/31
Registrant information
Name
Fariba Nasiriziba
Name of organization / entity
Tehran Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
f-nasiriziba@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-08-06, 1389/05/15
Expected recruitment end date
2010-10-07, 1389/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of huko point Ice massage on Pain degree during arterio-venous fistula puncture in hemodialysis patients
Public title
Effect of huko point Ice massage on Pain during arterio-venous fistula puncture in hemodialysis patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:age>18 year;oriented,capable oral and visual relation;no pain whole body before insert of needle into fistule
Exclusion criteria: drug abuse before insert of needle into fistule;need to try for more of once;alzimer;demencia;disease of preferal vascular;neuropathy;radiotherapy
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran
City
Tehran
Postal code
00981419733171
Approval date
2010-07-19, 1389/04/28
Ethics committee reference number
1743707
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
In first day without intervention. In second day after intervention
Method of measurement
Visual analoug scale
Secondary outcomes
1
Description
Side Effects Of Fistula
Timepoint
Before intervention
Method of measurement
Questionnair
Intervention groups
1
Description
Experimental group: received li4 ice massage at the 10 minute before arteriovenous fistula puncture: (Cold application 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 (hoku) (contralateral arm). Pain degree during arterio-venous fistula puncture was measured with using a subjective pain scale (visual analogue scale): in first day without intervention. In second day after 10 minute intervention in patients again pain degree was measured.
Category
Rehabilitation
2
Description
Control group 1: received massage in wrist of contralateral arm at the 10 minute before arteriovenous fistula puncture . Pain degree during arterio-venous fistula puncture was measured with using a subjective pain scale (visual analogue scale): in first day without intervention. In second day after 10 minute intervention in patients again pain degree was measured.
Category
Other
3
Description
Control group 2: received li4 massag massage at the 10 minute before arteriovenous fistula puncture, web between the thumb and index finger of the hand not having the AV fistula (hoku) (contralateral arm). Pain degree during arterio-venous fistula puncture was measured with using a subjective pain scale (visual analogue scale): in first day without intervention. In second day after 10 minute intervention in patients again pain degree was measured.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hasheminejad hospital
Full name of responsible person
Fariba soltanpoor
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. nikbakht
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fariba Soltanpoor
Position
Msc student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran
City
Tehran
Postal code
0098211419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
far_soltanpoor@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Nasiriziba
Position
Instructor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran
City
Tehran
Postal code
0098211419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
f-nasiriziba@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Soltanpoor
Position
Msc student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran
City
Tehran
Postal code
0098211419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
far_soltanpoor@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)