Compare auditory distraction and visual distraction on pain, stress and vital sign changes from due to needles insertion into arteriovenous fistula in elderly patients undergoing hemodialysis
The aim of this study is to compare two methods of visual distraction and auditory distraction to reduce the pain, stress and vital sign changes of the fistulas needles in hemodialysis elderly patients. For this purpose, a double blind controlled randomized clinical trial study is conducted on 120 hemodialysis elderly patients. The population of all hemodialysis elderly patients referred to the Ghiasi hospital. Through purposive sampling, patients were selected and randomly assigned to three groups will be (Routine method, visual distraction, and auditory distraction). Each sample group includes 40 patients. Each intervention will be done at three intermittent hemodialysis sessions. Demographic and clinical characteristics of the patients will be recorded with questionnaire. For the auditory distraction intervention group at three time nature based sounds and in visual distraction intervention group at three time films about nature will be done for 20 minutes. The intensity of stress before injection and the intensity pain after injection will be evaluated and recorded. Vital signs before and after the injection will be measured. All of the needles will be of the same material and size. Finally, the degree of pain, stress and vital sign changes resulted of the three groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709047529N14
Registration date:2017-09-19, 1396/06/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University Vice chancellor for research
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare auditory distraction and visual distraction on pain, stress and vital sign changes from due to needles insertion into arteriovenous fistula in elderly patients undergoing hemodialysis
Public title
The effect distraction on patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: the desire to participate in the study; over 60 years old; hemodialysis patients who have at least three session of dialysis at week; patients who have at least three months past of their fistula embedding; without alcohol and drugs consumption; the absence of cognitive impairment; not having vision or hearing problems; no history of mental illness with doctor approval.
Exclusion criteria: patient dissatisfaction to continue participation in the study; lack of turn later; candidate for a transplant; using analgesic or non-pharmacological to reduce pain in the past 24 hours; in need of a second needle insertion into arteriovenous fistula in case of failure in the first of the fistulas needles; pain existence in the other parts of body.
Age
From 60 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Postal code
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
Shahed.REC.1395.117
Health conditions studied
1
Description of health condition studied
Arteriovenous fistula puncture-related complication in hemodialysis patients
ICD-10 code
T82.4
ICD-10 code description
Mechanical complication of vascular dialysis catheter
Primary outcomes
1
Description
intensity of pain
Timepoint
After every intervention and immediately after the fistula needle
Method of measurement
Visual Pain Scale
2
Description
quality of pain
Timepoint
After every intervention and immediately after the fistula needle
Method of measurement
short-form McGill pain questionnaire
3
Description
Blood pressure
Timepoint
After every intervention and immediately after the fistula needle
Method of measurement
Checklist
4
Description
Respiratory rate
Timepoint
After every intervention and immediately after the fistula needle
Method of measurement
Checklist
5
Description
heart rate
Timepoint
After every intervention and immediately after the fistula needle
Method of measurement
Checklist
6
Description
stress
Timepoint
After every intervention and before the fistula needle
Method of measurement
Stress visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Interventions 1: For the auditory distraction intervention group at three intermittent hemodialysis sessions, nature based sounds at three time films about nature will be done for 20 minutes.
Skin will be disinfected for
vein puncture. Fistula is then punctured. In each intervention, the intensity of stress before injection and the intensity pain after injection will be evaluated and recorded.
Category
Other
2
Description
For the visual distraction intervention group at three intermittent hemodialysis sessions, films about nature will be done for 20 minutes. Skin will be disinfected for
vein puncture. Fistula is then punctured. In each intervention, the intensity of stress before injection and the intensity pain after injection will be evaluated and recorded
Category
Other
3
Description
Skin will be disinfected for vein puncture. Fistula is then punctured. at three intermittent hemodialysis sessions, the intensity of stress before injection and the intensity pain after injection will be evaluated and recorded
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghiasi Hospital
Full name of responsible person
Mina Ghadimi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University Vice Chancellor For Research
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine Of Imam Khomeini, Tehran-Qom Express Way, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University Vice Chancellor For Research
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
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran.
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)