Patients undergoing hemodialysis are exposed to stress and pain from approximately 300 punctures per year to their arteriovenous fistula. AVF punctures lead to a considerable degree of pain, due to the caliber and length of the bevel of fistula needles. Alleviation of this pain might improve their acceptance of the procedure and thus, their quality of life. The purpose of this study is comparison the effect of lidocaine gel and inhalation of lavender aromatherapy on pain intensity of arteriovenous fistula puncture in heamodialysis patients. This is a before and after clinical trial study. This study include 40 heamodialysis patients , first pain intensity of puncture measure without any intervention after needle insertion in arteriovenous fistula . one week later ,all patients receive lidocaine2% gel 15-20min before AVF puncture and 2week later , same patients inhale lavender aromatherapy 5min before AVF puncture. Pain intensity of needle insertion evaluate and record by patients immediately after cannulation on visual analogue scale. Interventions conduct in the three consecutive heamodialysis sessions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403082226N13
Registration date:2014-04-12, 1393/01/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-12, 1393/01/23
Registrant information
Name
Mansooreh Aliasgharpour
Name of organization / entity
Nursing & midwifery faculty, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 7120
Email address
aliasgha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect lidocaine gel and inhalation of lavender aromatherapy on pain score of arteriovenous fistula puncture in hemodialysis patients
Public title
Comparison of effect lidocaine gel and inhalation of lavender aromatherapy on pain of arteriovenous fistula puncture in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 18 yr of age or older; be conscious; non smoking; lake of damaged; denuded, or broken skin at the designated site; lake of known allergies or sensitivities to lidocaine, prilocaine or other local anesthetic; no sensitivities to lavender aromatherapy; non used of alcohol and opioid substances; have a good sense of smell; minimum of reading and writing; no history of mental disorders. Exclusion criteria: afflict severe cold or non have a healthy sense of smell; concomitant use of an analgesic within the previous 24 h; or previous use of lidocaine/ prilocaine cream; extend the time interval over 1 hour of drug administration; patient's unwillingness to continue the study; the patient died.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran university medical sciences-tehran
City
Tehran
Postal code
1419733171
Approval date
2014-02-20, 1392/12/01
Ethics committee reference number
93-01-28-25468
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
berore intervention and after every intervention
Method of measurement
Visual analoug scale
Secondary outcomes
empty
Intervention groups
1
Description
2 week later (washout) , same patients receive aromatherapy intervention. three drops of aromatherapy blend containing Lavender essence 10% were poured on cotton in cast containers, and the patient is asking to inhale it for 5 minutes from a distance of 7- 10 cm from the nose; and pain severity of venepuncture measure and record using the VAS . this intervention also conduct in the three consecutive dialysis sessions.
Category
Other
2
Description
one week later ,all patients receive lidocaine2% gel 15-20min before AVF puncture in area of 5cm2 at the designated site. No cover is placing at the designated site then gel remove and the skin disinfect before venepuncture and pain intensity of needle insertion evaluate and record by patients immediately after cannulation on visual analogue scale . this intervention conduct in the three consecutive dialysis sessions.
Category
Treatment - Drugs
3
Description
First patients complete a demographic questionnaire and pain visual analog scale and based on inclusion criteria entere into the study and pain intensity evaluate and record by patients immediately after cannulation without any intervention on visual analogue scale
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeyni hospital in Meianeh
Full name of responsible person
Reyhaneh Abbaszadeh
Street address
Nosrat east street -Faculty of nursing and midwifery - Tohid square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotoohi
Street address
4th Floor-The Center Building of Tehran University of Medical Sciences, Keshavarz Blvd, Ghods St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Reyhaneh Abbaszadeh
Position
MSc student of critical care nursing
Other areas of specialty/work
Street address
Nosrat east street -Faculty of nursing and midwifery - Tohid square
City
tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
abaszaderey04@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
tehran university of medical sciences
Full name of responsible person
Mansooreh Aliasgharpour
Position
MSc
Other areas of specialty/work
Street address
Nosrat east street -Faculty of nursing and midwifery - Tohid square
City
tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
aliasgha@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
tehran university of medical sciences
Full name of responsible person
Reyhaneh Abbaszadeh
Position
MSc student of critical care nursing
Other areas of specialty/work
Street address
Nosrat east street -faculty of nursing and midwifery - Tohid square
City
tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
abaszaderey04@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)