Comparison of the effects of aromatherapy with salvia officinalis and lavender essential oil on vascular needle insertion pain in hemodialysis patients
Comparison of the effect of aromatherapy with salvia officinalis and lavender essential oil on the intensity of pain during the insertion of vascular needles in hemodialysis patients.
Design
The clinical trial is conducted in three groups in a crossover, one-sided blind, randomized, on 30 hemodialysis patients. The rand function of Excel software was used for randomization.
Settings and conduct
This study is conducted in the hemodialysis department of Motamedi Hospital in Garmsar. The samples are selected by easy sampling according to the inclusion and non-entry criteria and are studied randomly in 3 ways: lavender scent, salvia officinalis scent, and placebo. Samples are not aware of the type of scent.
Participants/Inclusion and exclusion criteria
Age over 20 years
Olfactory health
No history of asthma
Not using perfume and cologne
No drug addiction
Absence of severe pain in other parts of the body
Intervention groups
In each of the aromatherapy methods (lavender, sage), the client inhales the aroma 10 minutes before and during arterial needling.
In the placebo method, the patient smells the scent of water 10 minutes before and during the injection.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110430006342N15
Registration date:2023-05-23, 1402/03/02
Registration timing:prospective
Last update:2023-05-23, 1402/03/02
Update count:0
Registration date
2023-05-23, 1402/03/02
Registrant information
Name
Ali Asghar Ghods
Name of organization / entity
Semnan Universioty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4192
Email address
aaghods@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of aromatherapy with salvia officinalis and lavender essential oil on vascular needle insertion pain in hemodialysis patients
Public title
Comparing the effects of lavender and salvia officinalis on pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with arteriovenous fistula for more than 3 months
Exclusion criteria:
Age under 20 years Absence of drug addiction8) Absence of severe pain in other parts of the body
Unhealthy sense of smell
No history of asthma
Not using perfume and cologne
No drug addiction
Absence of severe pain in other parts of the body
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The samples, which are 30 people and are fixed in all three groups, will randomly receive one of the 3 interventions at different times of visit. For this purpose, using RAND Excel, 30 blocks of 3 that show the order of intervention methods were randomly designed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Aromatherapy is performed by the researcher. Arterial needling is performed by a skilled nurse, and a visual analog scale of pain sheet will be given to the patients by another nurse who does not know about the type of scent to record their pain.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Deputy of research and technology, Central Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
IR.SEMUMS.REC.1402.017
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
pain severity
Timepoint
Immediately after arterial puncture in hemodialysis
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Pulse
Timepoint
5 minutes before the intervention and immediately after the intervention
Method of measurement
Sairan vital signs monitor device
2
Description
Respiration
Timepoint
5 minutes before the intervention and immediately after the intervention
Method of measurement
Sairan vital signs monitor device
3
Description
Blood Pressure
Timepoint
5 minutes before the intervention and immediately after the intervention
Method of measurement
Sairan vital signs monitor device
Intervention groups
1
Description
Intervention group: »Lavender scent. 4 drops of 100% lavender essential oil prepared by Shazdeh company are dripped on a layer of gauze and placed on the patient's neck at a distance of about 20 cm from the nose.
Category
Prevention
2
Description
Intervention group: salvia officinalis scent. 4 drops of 100% salvia officinalis essential oil prepared by Shazdeh company are dripped on a layer of gauze and placed on the patient's neck at a distance of about 20 cm from the nose.
Category
Prevention
3
Description
Control group: Placebo. 4 drops of warter are dripped on a layer of gauze and placed on the patient's neck at a distance of about 20 cm from the nose.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Motamedi Hospital in Garmsar
Full name of responsible person
Ali Asghar Ghods
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 912 231 9532
Email
aaghods@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohamadkhani
Street address
Deputy of research and technology, Central Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3105 2120
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
50
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
Semnan University of Medical Sciences
Full name of responsible person
Faezeh Ashori
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road,
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
faeze73ashoorey@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 9965 4190
Email
aaghods@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
aaghods@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Only information related to the main outcome can be shared.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
All researcher
Under which criteria data/document could be used
Mention the source of use
From where data/document is obtainable
Ali Asghar Ghods
aaghods@yahoo.com
What processes are involved for a request to access data/document