Objective: Comparison between two methods of non-pharmacological care on pain from entrance of needle into AV fistula in hemodialysis patients. Design: single blind. Studied population: Patients under therapy with hemodialysis by AV fistula that has criteria to be studied. Sample size: Thirty five peoples. Studied intervention: Pain assessment will be performed during 12 consecutive dialysis sessions, 3 times in a week. The first three sessions will be done before intervention and next nine sessions will be conducted with three different interventions among all patients in identical sequence. Before the intervention: visual analogue scale of pain intensity will be measured, after entrance needle into fistula, in the first three dialysis sessions. Then in the second three dialysis sessions, false point in a wrist which does not have fistula will be massaged for 5 minutes before and during the entrance of the needle into the fistula. In the third three dialysis sessions the handing hoku point which does not have fistula, will be massaged for 5 minutes. In a dialysis session rhythmic breathing will be taught the patients as they could do that. Then in the fourth three sessions, patients will do this method for 5 minutes before and during the entrance of the needle into the fistula. Pain intensity will be measured by the VAS after each intervention and entrance of needle into fistula. The primary outcome: If it will be cleared the positive effects of interventions on pain intensity caused by the entrance of needles into VA fistula which is compared and measured by using pain visual criterion, it is recommended a method to reduce the pain with the acceptance of responsibility by patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010111975N1
Registration date:2013-02-24, 1391/12/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-24, 1391/12/06
Registrant information
Name
Sophia Akbari
Name of organization / entity
Nursing and Midwifery School, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0150
Email address
s.akbari@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic Chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between two methods of non-pharmacological care on pain from entrance of needles in arteriovenous fistulas of hemodialysis patients
Public title
Non-pharmacological care of pain from needles in hemodialysis fistulas
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1-Patients with end-stage renal disease who are diagnosed by a doctor and they must be under therapy with hemodialysis at least three months before participating in this study; 2- Having arteriovenous fistula; 3-Be able to communicate verbally and visually; 4- Lack of vascular access problem; 5-Absence of neuropathic disorders; 6-Absence of peripheral vascular disease.
Exclusion criteria: 1-Require more than one attempt to puncture the fistula; 2-Decrease level of consciousness and agitation; 3-Existence of Inflammation and bites or fracture on massaged point; 4-The use of other methods for reducing pain.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan university of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamedan
Postal code
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
3497/9/35/16/پ/د
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 each intervention.
Method of measurement
VAS (visual analogue scale).
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention: Pressure on the false point. At three dialysis sessions, researcher will massage false point for 5 minutes in a wrist which is lack of fistula, before and during the entrance of the needle into the fistula. Then after the entrance of the needle into the fistula, the pain intensity will be measured by VAS.
Category
Placebo
2
Description
The second intervention: At three dialysis sessions the handing hoku point will be massaged for 5 minutes before and during the entrance of the needle into fistula. Then pain intensity will be measured by VAS.
Category
Other
3
Description
The third intervention: At one dialysis session, rhythmic breathing will be taught.
Category
Behavior
4
Description
The fourth intervention: Patients before and during the entrance of needle into fistula will do rhythmic breathing for 5 minutes. Then pain intensity will be measured by VAS.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Sophia Akbari- MSC Student of Medical-Surgical Nursing
Street address
Besat Hospital, Shahid Motahari Ave. Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Heidar Tavilani
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic Chancellor of Research and Technology, Hamadan 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
Nursing and Midwifery School, Hamadan University of Medical Sciences
Full name of responsible person
Sophia Akbari
Position
MSC Student of Medical- Surgical Nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamedan
Postal code
Phone
+98 81 1838 0527
Fax
Email
s.akbari@umsha.ac.ir sophia.akbari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Internal Medicine and Surgery, Nursing and Midwifery School, Hamadan University of Med
Full name of responsible person
Seyed Reza Borzou
Position
PhD Candidate
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamedan
Postal code
Phone
+98 81 1838 0527
Fax
Email
borzou@umsha.ac.ir edu1374@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery School, Hamadan University of Medical Sciences
Full name of responsible person
Sophia Akbari
Position
MSC Student of Medical- Surgical Nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamedan
Postal code
Phone
+98 81 1838 0527
Fax
Email
s.akbari@umsha.ac.ir sophia.akbari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)