Determination of apparent anxiety before and after inhalation of rose essential oil in myocardial infarction patients
• Determination of hidden anxiety before and after inhalation of rose essential oil in myocardial infarction patients
Design
A randomised, blinded, controlled clinical trial with 80 patients
Settings and conduct
It is performed in patients with acute coronary syndrome in Heshmatieh Hospital. The data collection method is a questionnaire.In the intervention group, rose essential oil is used and in the control group, sesame oil is used for 3 days and patients' anxiety is recorded before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria were age of 40-80 years, literacy, no history of mental illness, conscious of time, place and person, having the first experience of acute chest pain, no addiction to smoking and drugs, no olfactory disorder, and the absence of asthma, respiratory problems, and a history of allergies to plant odors
Intervention groups
In addition to the routine treatment in the ward, the intervention group received three drops of REO (Barij Pharmaceutical Co., manufacturing license No. 4215 from the Ministry of Health). REO was poured on non-absorbable napkins with a dropper and pinned to the patients' collar. They were asked to breathe normally for 20-30 min, which was done 3 times a day with an interval of 30 min between inhalations for 3 days.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041891N1
Registration date:2021-07-13, 1400/04/22
Registration timing:retrospective
Last update:2021-07-13, 1400/04/22
Update count:0
Registration date
2021-07-13, 1400/04/22
Registrant information
Name
Alemeh Dehnabi
Name of organization / entity
Tarbiat modares university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 4398
Email address
a.dehnabi95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-29, 1399/11/10
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
2021-01-29, 1399/11/10
Actual recruitment end date
2021-06-05, 1400/03/15
Trial completion date
2021-06-20, 1400/03/30
Scientific title
The effect of aromatherapy with rose essential oil on apparent anxiety in patients with myocardial infarction
Public title
The effect of aromatherapy with rose essential oil on apparent anxiety in patients with myocardial infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having the first experience of acute chest pain
Age of 30-70 years
Having hemodynamic stability
No history of mental illness, conscious of time, place and person
Literacy
Score 20 or higher on the overt and covert anxiety scale
No olfactory disorder
No addiction to smoking and drugs
Absence of asthma, respiratory problems, and a history of allergies to plant odors
Exclusion criteria:
The use of benzodiazepines, sedatives, and opioids
Sudden changes in hemodynamic status
Dissatisfaction with patient cooperation during the study
History of eczema and allergies to plants
History of migraines and chronic headaches
Active psychological disease as diagnosed by a physician
Olfactory disorder
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was purposeful and available. Eligible samples were randomly assigned to one of the two intervention (Inhalation aromatherapy) and control (Placebo inhalation) groups.The researcher, after the initial selection of the sample (according to the admission conditions) and the satisfaction of the patients, measured their anxiety using the Spielberger anxiety questionnaire If the score was more than 20, the demographic characteristics form and the disease information form were completed.Depending on which group the patient was in, they received their own intervention. It should be noted that patients' rooms in the intervention group were different from that of the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants become blind using a placebo and unaware of the materials used.
Due to the fact that the study was conducted by a sampler and recorded, the data were coded and sent by him to the outcome and data analyzer, these people are also considered blind.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Asad Abadi Ave, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
IR.Medsab.rec.1395.124
Health conditions studied
1
Description of health condition studied
Myocardial Infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Anxiety
Timepoint
Measure the level of anxiety before the intervention and then after the intervention daily for 3 days
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group received three drops of REO (Barij Pharmaceutical Co., manufacturing license No. 4215 from the Ministry of Health). REO was poured on non-absorbable napkins with a dropper and pinned to the patients' collar. They were asked to breathe normally for 20-30 min, which was done 3 times a day with an interval of 30 min between inhalations for 3 days
Category
Treatment - Other
2
Description
Control group: The control group received three drops of three drops of sesame oil (placebo) that was poured on non-absorbable napkins with a dropper and pinned to the patients' collar. They were asked to breathe normally for 20-30 min, which was done 3 times a day with an interval of 30 min between inhalations for 3 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatie hospital
Full name of responsible person
Mohammad Haddi
Street address
Asadabadi str , Sabzevar, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1600
Fax
+98 51 4423 8718
Email
heshmatie@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hussein Saqi
Street address
Tohid Shahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
Saghimh@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Haddadi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 74, AmirKabir 71 Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617733844
Phone
+98 51 4466 5671
Email
m.haddadi96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Haddadi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 74, AmirKabir 71 Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617733844
Phone
+98 51 4466 5671
Email
m.haddadi96@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Alemeh Dehnabi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617733844
Phone
+98 51 4466 5671
Email
a.dehnabi95@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study protocol is made available to the public through the writing and publication of the article.
When the data will become available and for how long
Access time after publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions and people working in industry
Under which criteria data/document could be used
No specific point is considered
From where data/document is obtainable
Mohammad Haddadi
m.Haddadi96@gmail.com
What processes are involved for a request to access data/document
Coordination with the Vice Chancellor for Research and Technology of Sabzevar University of Medical Sciences