Comparing the effect of cold and heat stimulation of the Hoku point on pain of needling arteriovenous fistulas in elderly patients undergoing hemodialysis
The objective of this study is comparing the effect of cold and heat massage of the Hoku point on pain of needling arteriovenous fistula in elderly patients undergoing hemodialysis. This study is a randomized, single-blind clinical trial conducted in Akhavan hemodialysis center in Kashan, Iran, in 2014. The study was conducted on 24 elderly patients being in ages of 60 years and over who were chosen easily. Data collection was Performed using a two-party instrument. The first part consists of questions on demographic characteristics including age, gender, marital status,... The second part of the instrument was a visual analog scale (VAS) for assessing the severity of pain the patients experienced during needling the AVF; and this scale was recorded by a nurse who wasn't aware of the type of intervention. The intervention was performed by a researcher or an assistant researcher. To remove the effect of inculcation on patients, interventions were performed in a rotating method; at the first session, thus, the first patient had an ice massage, whereas the second patient had a warm pack massage at the same session. Sampling was carried out for three months. Pain related to needle insertion was measured after four types of interventions on the Huko acupoint including ice massage warm massage, using 37 degrees centigrade water and after routin method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051122210N1
Registration date:2015-08-23, 1394/06/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-23, 1394/06/01
Registrant information
Name
Masoumeh Kavianpoor
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5542 8894
Email address
research@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-08-19, 1393/05/28
Expected recruitment end date
2014-11-17, 1393/08/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of cold and heat stimulation of the Hoku point on pain of needling arteriovenous fistulas in elderly patients undergoing hemodialysis
Public title
Comparing the effect of cold and heat massage of the Hoku point on pain of needling arteriovenous fistulas in elderly patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:being in ages of 60 years and over; being under regular hemodialysis; willingness to participate in the study; having no impairment in consciousness and vision; being able to communicate verbally; having no pain before hemodialysis session; not using any opiate or analgesic drugs at least 4 hours before the hemodialysis session; not having a known dementia; peripheral vascular disorder and diabetic neuropathy; lack of any inflammation bite or fracture on the massage location or the Huko point; and lack of any complications in the AVF (i.e. thrombosis; infection; aneurysm). The exclusion criteria were requiring more than one attempt to establish a needle in the AVF in hemodialysis session; a decision to withdraw from the study; the incidence of any problems in the Huko point; and occurrence of any local complications in the AVF (i.e. thrombosis; infection; and aneurysm) during the study.
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd, Kashan
City
kashan
Postal code
009887155/11
Approval date
2014-08-13, 1393/05/22
Ethics committee reference number
p/29/5/1/2563
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 and after the intervention.
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Local complications, fistula
Timepoint
Before and during the intervention.
Method of measurement
Check fistula
Intervention groups
1
Description
In the first type of intervention, a 50 mL plastic bottle made of polyethylene with a child-proof lock, containing ice was placed on the Huko point of the hand without an AVF and moved slowly on a rotating basis for ten minutes before needling of the AVF and continued during needle insertion till the nurse fixed the needles.
The level of pain using the Visual Analogue Scale was recorded by the patient. The second intervention was the same as the first on except that the bottle contained 50 mili Literof warm water with a temperature of 43-45 degree centigrade. The third intervention was also the same except that the bottle contained 50 mL of 37 degree centigrade water.
The last time without interference and to control the amount of pain was measured.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan Hospital
Full name of responsible person
Masoumeh Kavianpoor
Street address
Abazar Street
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Ghotb Ravandi Blvd, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Masoumeh Kavianpoor
Position
Master Of Nursing Science Student
Other areas of specialty/work
Street address
Ghotb Ravandi Blvd, Kashan
City
Kashan
Postal code
009887155/111
Phone
+98 31 5554 0021
Fax
Email
mkavianpoor77@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Rahele Mohseni
Position
Tutor
Other areas of specialty/work
Street address
Ghotb Ravandi Blvd, Kashan
City
Kashan
Postal code
009887155/11
Phone
+98 31 5554 0021
Fax
Email
numohseni@gmail.om
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Masoumeh Kavianpoor
Position
Master Of Nursing Science Student
Other areas of specialty/work
Street address
Ghotb Ravandi Blvd, Kashan
City
kashan
Postal code
009887155/111
Phone
+98 31 5554 0021
Fax
Email
mkavianpoor77@yahoo.om
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)