Comparison of the effect of Aromatherapy with Salvia officinalis and topical lidocaine gel on pain intensity during insertion of vascular needles in patients undergoing hemodialysis
Comparison of the effect of aromatherapy with Salvia officinalis and topical lidocaine gel on pain intensity during insertion of vascular needles in patients undergoing hemodialysis
Design
This study is a clinical trial before and after. The sampling was done in the available method and 23 patients were randomly selected in 3 step: without intervention, intervention with topical lidocaine gel, and intervention with aromatherapy with Salvia officinalis from hemodialysis patients referred to the hemodialysis section.
Settings and conduct
From the hemodialysis patients referred to Allameh Bohlool Hospital in Gonabad, the patients who have entry criteria, 23 patients were selected and The written consent was taken and at the first step, for them a demographic questionnaire and visual analog scale without any intervention after insertion of vascular needles at the part of fistula or graft, completed and the second step, intervention with topical lidocaine gel was performed and the intensity of pain was measured immediately after needle insertion by visual analog scale. And in the third step, an intervention with aroma of Salvia officinalis on the samples is done and the pain intensity will be measured.
Participants/Inclusion and exclusion criteria
The population under study are hemodialysis patients who experience needle pain and should be: over 18 and alert, have a good smell and lack of sensitivity to herbal and non-addictive narcotics and Alcohol and non-compliance conditions including severe allergy during the study and dissatisfaction for the continuation of the study.
Intervention groups
intervention in three steps: without intervention and intervention with topical lidocaine gel and intervention with aroma of Salvia officinalis.
Main outcome variables
The intensity of the pain caused by the entry of vascular needles at the fistula or graft in patients undergoing hemodialysis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190622043977N1
Registration date:2019-07-17, 1398/04/26
Registration timing:registered_while_recruiting
Last update:2019-07-17, 1398/04/26
Update count:0
Registration date
2019-07-17, 1398/04/26
Registrant information
Name
Bahareh Nikraftar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
bahar.nic.1358@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-16, 1398/04/25
Expected recruitment end date
2019-08-11, 1398/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Aromatherapy with Salvia officinalis and topical lidocaine gel on pain intensity during insertion of vascular needles in patients undergoing hemodialysis
Public title
Comparison of the effect of Aromatherapy with Salvia officinalis and topical lidocaine gel on pain intensity during insertion of vascular needles in patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18 yr of age or older
Lack of allergy to plants and the aroma
No use of palliative about 6 hours ago
No damaged skin at the desired part
lake of known allergies or sensitivities to lidocaine, prilocaine or other local anesthetic
Lack of olfactory disorder
Lack of addiction to drugs and alcohol
Having a minimum reading and writing literacy
Being conscious patient
Lack of severe pain in other places
Exclusion criteria:
Dissatisfaction to continue the research
Death or hospitalization in other wards
Allergy or critical reaction during the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
23
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
Ethics Committee of Gonabad University of Medical Sciences
Street address
Dr. Mahdizadeh Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2019-06-24, 1398/04/03
Ethics committee reference number
IR.GMU.REC.1398.043
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
Measuring the severity of pain caused by needle insertion before any intervention and after intervention with topical lidocaine gel and intervention with the aromatherapy with Salvia officinalis
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 3: In the next meeting on the same group, intervention will be done with aromatherapy. An oil drop of a concentration of 10% Salvia officinalis aroma from Zardband Pharmaceuticals Company, 3 drops are dropped into gas of 4x4 cm and is attached 20cm away from the patient's nose to his collar and the patient breathes for 5 minutes normally, and after the intervention, the severity of pain will be measured.
Category
Other
2
Description
Intervention group 2: The next session is an intervention with 2% lidocaine gel prepared in Sina-Darou Company, which is applied in the area of 5cm2 locally for 15 minutes before the needle is inserted. Then the gel is cleaned from the skin and the skin is disinfected to enter the vascular needle. The severity of the patient's pain will be evaluated and recorded immediately after needling by visual analog scale.
Category
Treatment - Drugs
3
Description
Intervention group 1: Patients first complete the demographic and visual analog scale based on inclusion criteria entry into the study and immediately be assessed and recorded without any intervention of pain caused by entery of needle in fistula or graft with visual analog scale.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Bohlool Gonabadi Hospital
Full name of responsible person
Bahareh Nikraftar
Street address
Vahdat Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Fax
+98 51 5723 6160
Email
Bohlool@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Shahla Khosravan
Street address
Dr. Mahdizadeh Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 9025
Email
info@gmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Bahareh Nikraftar
Position
Master of science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Mahdizadeh Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 9025
Email
bahar.nic.1358@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Mojalli
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr. Mahdizadeh Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 9025
Email
Mojalli.m@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Bahareh Nikraftar
Position
Master of science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Mahdizadeh Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 9025
Email
bahar.nic.1358@gmail.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