Efficacy of Aromatherapy with peppermint essential oil on patients with nausea
Design
Randomized ,blinded , Clinical trial with control group , with parallel groups ,with 156 patients with nausea, single blind.
Settings and conduct
Patients with nausea referred to emergency department of Sina hospital; none of the staff and patients were aware of which patients received medication or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18 years, Ability to understand and sign a consent form, self-reported nausea severity of 3 or
greater on a verbal numeric response scale (range 0 to 10)
Exclusion criteria:
known allergy to peppermint essential oil, inability to inhale through the nares ( include rhinitis), recent intake of antivomiting medications including Ondansetron, Metoclopramide, Granisetron, Domperidone, clinical suspicion for serotonin syndrome, pregnancy, changing the state of consciousness (to prevent the misunderstanding and signing of the informed consent form)
Intervention groups
Intervention group: The first treatment group consists of 56 patients receiving inhaled peppermint essential oil 3 times and oral placebo (which apart from the active ingredient,were similar to ondansetron tablets) for 2 minutes.
Intervention group: The second treatment group consists of 56 patients receiving 4 mg oral ondansetron and inhaled peppermint essential oil 3 times for 2 minutes.
Control group:Control group consists of 56 patients receiving 4 mg oral ondansetron and inhaled saline solution placebo (which apart from the active ingredient,were similar to peppermint essential oil) 3 times for 2 minutes.
Main outcome variables
nausea score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170609034406N6
Registration date:2020-09-23, 1399/07/02
Registration timing:retrospective
Last update:2020-09-23, 1399/07/02
Update count:0
Registration date
2020-09-23, 1399/07/02
Registrant information
Name
Afshin Gharekhani
Name of organization / entity
Faculty of Pharmacy/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1315
Email address
gharekhania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-30, 1398/08/08
Expected recruitment end date
2020-09-10, 1399/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of smelling peppermint essential oil on patients with nausea referred to emergency department of Sina Hospital
Public title
Efficacy of smelling peppermint essential oil on patients with nausea referred to emergency department of Sina Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Ability to understand and sign a consent form
self-reported nausea severity of 3 or greater on a verbal numeric response scale (range 0 to 10)
Exclusion criteria:
known allergy to peppermint essential oil
inability to inhale through the nares ( include rhinitis)
recent intake of antivomiting medications including Ondansetron, Metoclopramide, Granisetron, Domperidone
clinical suspicion for serotonin syndrome
pregnancy
Changing the state of consciousness so as to prevent the understanding and signing of the informed consent form
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
168
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Permuted Block Randomization method was used for entering patients in control and treatment groups.
Random method and description of each method: simple randomization, block
Arrange the accident stages:
1) Determine the volume of each block (blocks of 6)
2) Prepare a list of 90 blocks and assign numbers to them
AABBCC(1) ABCBAC(2) ABCCBA(3) ... CBAABC(90)
3) Choosing 28 random numbers between 1 and 90
4) Identification of the Treatment Assignment
Blinding (investigator's opinion)
Single blinded
Blinding description
This study was conducted in a single blind clinical trial. None of the people distributing drugs and patients were aware of which patients received the drug or placebo of Ondansetron, and were only diagnosed with the numbers given by the system to the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
No 2 Central Building , Tabriz University of Medical Sciences , Golgasht Street , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2019-08-21, 1398/05/30
Ethics committee reference number
IR.TBZMED.REC.1398.581
Health conditions studied
1
Description of health condition studied
nausea
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
2
Description of health condition studied
vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
3
Description of health condition studied
pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
4
Description of health condition studied
Duration of being in the emergency department
ICD-10 code
ICD-10 code description
5
Description of health condition studied
Patient satisfaction at discharge from emergency ward
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
nausea score
Timepoint
Immediately before intervention. 5،10،20،30،60 minutes after the intervention.
Method of measurement
Verbal Numeric Scale
2
Description
Vomiting frequency
Timepoint
Immediately before intervention. 5،10،20،30،60 minutes after the intervention.
Method of measurement
Standard questionnaire
3
Description
pain score
Timepoint
Immediately before intervention. 5،10،20،30،60 minutes after the intervention.
Method of measurement
Verbal Numeric Scale
Secondary outcomes
1
Description
Duration of being in the emergency department
Timepoint
after the intervention
Method of measurement
previously designed checklist for recording the time
2
Description
Patient satisfaction at discharge from emergency ward
Timepoint
after the intervention
Method of measurement
previously designed checklist for recording patient satisfaction
Intervention groups
1
Description
Intervention group: The first treatment group consists of 56 patients receiving inhaled peppermint essential oil 3 times and oral placebo (which apart from the active ingredient,were similar to ondansetron tablets) for 2 minutes.
Category
Treatment - Drugs
2
Description
Intervention group: The second treatment group consists of 56 patients receiving 4 mg oral ondansetron and inhaled peppermint essential oil 3 times for 2 minutes.
Category
Treatment - Drugs
3
Description
Control group:Control group consists of 56 patients receiving 4 mg oral ondansetron and inhaled saline solution placebo (which apart from the active ingredient,were similar to peppermint essential oil) 3 times for 2 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Afshin Gharekhani
Street address
Sina Medical Research and Training Hospital Shahid Montazeri and Hafez Squares Azadi Street Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8342
Email
gharekhania@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiei
Street address
Center of Tabriz Medical University,Daneshgah St, Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy , Tabriz University of Medical Science , Daneshgah Street , Tabriz , Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5351
Email
gharekhania@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy , Tabriz University of Medical Science , Daneshgah Street , Tabriz , Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5153
Email
gharekhania@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parinaz Feyzi
Position
Pharmacy Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Pharmacy
Street address
Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5153
Email
Parinaz.feyzi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Threre is no further information
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