Comparative study of effect of two methods related to ice massage in Huko point and Valsalva maneuver on pain intensity during needle insertion into arteriovenous fistula of hemodialysis patients
Purpose: Comparison of two methods of ice massage in Hoku point and Valsalva maneuver on pain intensity during needle insertion of arteriovenous fistula in hemodialysis patients in selected hospitals in Isfahan in 2015
Study design: non-randomized clinical trial
The methods used included:
A study population:
Main inclusion criteria: patient be alert. hemodialysis is performed Through fistula, patients are older than 18 years of age.
The main criteria for exclusion: unwillingness to cooperate, died, inability to perform the Valsalva maneuver, the inability of access to the vessels in the first attempt
Sample size: 70
(B) intervention or interventions studied: ice massage in Hoku point in Contralateral hand with fistula, Valsalva maneuver
C-time intervention: ice massage is performed 10 min prior to cannulation and during it and Valsalva maneuver 20 seconds before needle insertion or cannulation
(D) the primary outcome or consequences of the study: objective and subjective pain intensity during fistula cannulation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081423615N1
Registration date:2015-09-18, 1394/06/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-18, 1394/06/27
Registrant information
Name
Elham Davtalab
Name of organization / entity
Islamic Azad University Isfahan( Khorasgan) Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 3375 0848
Email address
e.davtalab@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Islamic Azad University Isfahan (Khorasgan) Branch.
Expected recruitment start date
2015-03-05, 1393/12/14
Expected recruitment end date
2015-04-04, 1394/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of effect of two methods related to ice massage in Huko point and Valsalva maneuver on pain intensity during needle insertion into arteriovenous fistula of hemodialysis patients
Public title
Comparison of the effects of ice massage and Valsalva maneuver on pain
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: patients in the study are hemodialysis; dialysis performed from arteriovenous fistula; be willing to participate in the study; older than 18 years; fully conscious and able to answer their questions; verbal and visual communication can be achieved; no sever pain in the body area before inserting the needle into the fistula ; history of drug abuse not mentioned; during the 6 hours before hemodialysis is not used analgesics or sedatives;avf cannulation is possible to one try of cannulation; history of diseases such as Alzheimer's, dementia, peripheral vascular disease, diabetic neuropathy disorders not mentioned; heart disease, glaucoma, increased pressure in the brain, the eyes do not have a recent surgery ; have not inflammation and damage, redness, pain and bruise on the skin av fistula; does not mention sensitivity to ice massage;be able to perform the Valsalva maneuver and keeping the mercury column manometer to the pressure of 20 mmHg for 20 seconds .
Exclusion criteria:the patient's unwillingness to continue participating in the study;
Death and absence in the second session to continue treatment; the lack of proper venipuncture every effort in the second session of hemodialysis; the use of a sedative before the start of the second session of hemodialysis;inability to perform the Valsalva maneuver correctly.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Etichs Committee of Isfahan University of Medical Sciences and Health Services
Street address
Hezarjarib Street
City
Isfahan
Postal code
81786-73461
Approval date
2015-02-09, 1393/11/20
Ethics committee reference number
293335
Health conditions studied
1
Description of health condition studied
Hemodialysis patient
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease
Primary outcomes
1
Description
Objective pain
Timepoint
Before and immediately after the intervention
Method of measurement
Abbey pain scale
2
Description
Subjective pain
Timepoint
Before and immediately after the intervention
Method of measurement
Numerical Rating Scale 0-10
Secondary outcomes
1
Description
Bloold pressure and pulse rate
Timepoint
10 minute prior of cannulation and 5 minute after the cannulation
Method of measurement
Heart and blood pressure monitoring device
Intervention groups
1
Description
"control group: After disinfection of the arteriovenous fistula, without performing any action, inserting needle in to av fistula in contralateral hand with av fistula, was done."
Category
Other
2
Description
" intervention group: Using an ice ball with a diameter of 1.5-2 cm, was wrapped in a plastic glove, the space between the thumb and forefinger of cotralateral hand with fistula, 10 minutes before and 2 minutes during insertion of needle in to the avf,circular was massaged. "
Category
Other
3
Description
"intervention group: The patients were asked to blow in the hole of disposable syringe that is placed in one side plastic tube manometer and the other end of tube, was connected to the sphygnomanometer and lift mercury column up to 20 mm Hg and maintain height of the mercury column for 20 seconds to 20 mmHg. 20 seconds after, inserting needle in arteriovenous fistula was performed."
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Majesty Zahra Hospital
Full name of responsible person
Elham Davtalab, MS of Nursing Education
Street address
Bigining Alameh Majlesi Street
City
Isfahan
2
Recruitment center
Name of recruitment center
Amin Hospital-Isfahan
Full name of responsible person
Elham Davtalab, MS of Nursing Education
Street address
Amin Hospital-Isfahan, Shohada Squre, Ebne Sina Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Reaserch of Islamic Azad University Isfahan