Effecting of Arnica ointment and distraction on the pain caused by fistula needles in hemodialysis patients in Zahedan University of Medical Sciences Hospital's in 2017
Determine effecting of Arnica ointment and distraction on the pain caused by fistula needles in hemodialysis patients in Zahedan University of Medical Sciences Hospitals
Design
In this study, 93 hemodialysis patients referred to Ali Ibn Abitaleb and Khatam (peace be upon him)
Hospital in Zahedan were selected based on inclusion criteria. The participants were randomly divided into two groups, including intervention and control group.
Settings and conduct
This study was conducted in dialysis unit at Ali Ibn Abitaleb and Khatem (peace be upon him) Hospital in Zahedan. Arnica cream in Arnica group, playing pictures along with music in distraction group and Vaseline cream will be used as placebo in control group before the cannulation. Uniform Arnica and Vaseline cream will be used for blinding. Also pain score will be measured and recorded by a research assistant without knowledge about the applied cream.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients aged over 18 years.
2- Consciousness, ability to communicate and collaborate.
3- Patients needed hemodialysis at least twice a week.
4- Taking no sedatives or any opiate drugs 6 hours before hemodialysis.
5- Absence of pain in other organs.
6- Absence of skin issues or Anesthesia at the vascular access point.
7- Diabetic patients without neuropathy.
Exclusion criteria:
1- Developing an ulcer in fistula at any process of study
2- Displacement of fistula needles in appropriate place at first cannulation.
3- Patient death.
Intervention groups
Arnica cream group: Arnica cream will be applied to area about 5 cm2 above the fistula 60 minutes before fistula needling and then the cannulation will be proceeded.
Distraction group: The cannulation will be proceeded 10 minutes after playing pictures of nature.
Control group: Vaseline cream will be applied to the area about 5 cm2 above the fistula needle, then the cannulation will be proceeded.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170806035520N3
Registration date:2018-02-05, 1396/11/16
Registration timing:registered_while_recruiting
Last update:2018-02-05, 1396/11/16
Update count:0
Registration date
2018-02-05, 1396/11/16
Registrant information
Name
Alireza Salar
Name of organization / entity
Faculty of nursing and midwifery Zahedan
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
salar@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-02-09, 1396/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effecting of Arnica ointment and distraction on the pain caused by fistula needles in hemodialysis patients in Zahedan University of Medical Sciences Hospital's in 2017
Public title
"The effect of Distraction on the pain of the needle fistula""Effect of Arnica on Fistula Needle Pain"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Consciousness, ability to communicate and collaborate.
Patients needed hemodialysis at least twice a week.
Taking no sedatives or any opiate drugs 6 hours before hemodialysis.
Absence of pain in other organs.
Absence of skin issues at the vascular access point.
Diabetic patients without neuropathy.
Exclusion criteria:
Developing an ulcer in fistula at any process of study
Displacement of fistula needles in appropriate place at first cannulation.
Patient death
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized
Blinding (investigator's opinion)
Double blinded
Blinding description
double blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Zahedan university of medical sciences
Street address
Administrative Complex of Khalij Fars Blvd, University of Medical Sciences, Dr Hasabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2017-12-24, 1396/10/03
Ethics committee reference number
IR.ZAUMS.REC.1396.288
Health conditions studied
1
Description of health condition studied
Fistula needle pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
After the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
First interventionIn:In this method Arnica ointment is rubbed into the injection site at 5 centimeters with holder dressing 60 minute before the injection and dressing is removed after the one hour, then area is cleaned and injection is performed.This intervention is performed in two consecutive hemodialysis sessions.
Category
Prevention
2
Description
Secound Intervention group: Nature pictures and music are played using laptop and headphone and after 10 minutes, the injection is done while playing pictures and music.This intervention is performed in two consecutive hemodialysis sessions.
Category
Prevention
3
Description
Control group: In this method Vaseline ointment is rubbed into the injection site at 5 centimeters with holder dressing 60 minute before the injection and dressing is removed after the one hour, then area is cleaned and injection is performed.This intervention is performed in two consecutive hemodialysis sessions.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebn abitaleb(s) hospital
Full name of responsible person
Alireza salar
Street address
Behdasht blvd, Zahedan Faculty of Nursing and Midwifery, Zahedan, Sistan and Baluchestan, Islamic Republic Of Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
salar293@gmail.com
2
Recruitment center
Name of recruitment center
Khatam(s) hospital
Full name of responsible person
Alireza salar
Street address
Behdasht blvd, Zahedan Faculty of Nursing and Midwifery, Zahedan, Sistan and Baluchestan, Islamic Republic Of Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
salar293@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr noormuhammad bakhshani
Street address
Zahedan University of Medical Sciences, Khalije Fars Boulevard, Dr Hesabi Square, Zahedan, Sistan and Baluchestan, Islamic Republic Of Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Phone
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Raghibi
Position
master student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Behdasht blvd - Zahedan Faculty of Nursing and Midwifery Zahedan Sistan and Baluchestan Iran, Islamic Republic Of
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
raghibi_58@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Salar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zahedan univercity of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
salar@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Raghibi
Position
master student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Behdasht blvd, Zahedan Faculty of Nursing and Midwifery, Zahedan, Sistan and Baluchestan, Islamic Republic Of Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
raghibi_58@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available