Determine the effect of aromatherapy on the anxiety of candidates for coronary angiography
Design
Double-blind clinical trial - A total of 80 patients - two intervention and control groups
Settings and conduct
This study is a double blind clinical trial (patients, carers, and analyst) that will be performed on patients undergoing coronary artery angiography which will be hospitalized in the post cath. of Shahid Mohammadi Hospital in Bandar Abbas. Units are randomly divided into two groups intervention and control. The control group will inhale the pads stained with 0.2 ml of the placebo and the intervention group of the mint essence impregnated pads as much as they will attach to the front of the sybase for 20 minutes. The level of anxiety and vital signs of the patient will be recorded before and after the intervention. A demographic questionnaire, a Spielberger standard questionnaire, and a vital signs registration form will be used to collect information.
Participants/Inclusion and exclusion criteria
Entry requirements: For the first time, only undergo angiography. Not heart valve disease, full allert, lack of vision and hearing And olfactory, liver, kidney, respiratory, allergy and psychologic disease , no addiction, age range of 18-60 years, no use of sedative drugs 4 hours before intervention.Conditions of exclusion: Not participating in the study, changes in vital signs and cardiac dysrhythmia .Not having the criteria for entering the study.
Intervention groups
The control group in room 1; having a non-absorbent eye pad and 0.2 ml normal saline attached to the chest is studied for 20 minutes; the same procedure will go on for intervention group in room 2, actually peppermint oil of Barij essence company will be used instead at 0.2 ml for eye pads.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
رایحه درمانی
IRCT registration information
IRCT registration number:IRCT20190225042844N1
Registration date:2019-03-09, 1397/12/18
Registration timing:registered_while_recruiting
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Roghaye Koohestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 7904
Email address
roghayekoohestani2028@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy on anxiety of candidates for coronary angiography in Shahid Mohammadi Bandar Abbas Hospital in 2018
Public title
The study effect of aromatherapy on anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
For the first time undergo coronary artery angiography.
Only undergo coronary artery angiography.
Before undergoing angiography, they are not subjected to other invasive methods such as echocardiography
Not having heart valve disease.
All units have full vigilance and are not in severe conditions.
There is no visual and hearing loss and no smell.
Not having respiratory and allergic problems.
Not having drug additction.
There is no liver and kidney problems.
The age range is between 18 - 60 years old.
Do not take sedative medicines 4 hours before the intervention.
Not having a history of mental illness.
Exclusion criteria:
Unwilling to participate in the study.
Allergic to peppermint oil
With the risk of dysrhythmia.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The units are divided randomly into two intervention and control groups using the random allocation software. In this table, numbers from 1 to 80 are classified where each number belongs to a group (intervention or control) that is randomly assigned to that group. The first case will be assigned to one number and its associated group, and the rest of the samples will be included in the study accordingly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and carers do not know which patient will fall into any of the groups (aromatherapy or controls). Because the data is encoded, the data analyzer is also blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bandar Abbas University of Medical Sciences
Street address
Research and Technology Dept., Shahid Mohammadi Hospital, Shahid Chamran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
IR.HUMS.REC.1397.300
Health conditions studied
1
Description of health condition studied
Anxiety in patients undergoing angiography
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
An hour before angiography and after intervention
Method of measurement
Spielberger questionnaire
Secondary outcomes
1
Description
Systolic Blood Pressure
Timepoint
An hour before angiography and after intervention
Method of measurement
Dial Sphygmomanometer
2
Description
Dyastolic Blood Pressure
Timepoint
An hour before angiography and after intervention
Method of measurement
Dial Sphygmomanometer
3
Description
pulse
Timepoint
An hour before angiography and after intervention
Method of measurement
Chronometer
4
Description
Respiratory
Timepoint
An hour before angiography and after intervention
Method of measurement
Chronometer-Inspection the movements of the chest
Intervention groups
1
Description
Intervention group: An hour prior to angiography, the patient's vital signs will be monitored and the demographic and Spielberger questionnaires will be completed, then the pads stained with 0.2 ml of peppermint essential oil will be attached to the front of the chest at the concentration of 100% of the baricha essence of Kashan. It will be inhaled for 20 minutes. Then, the vital signs are checked and the Spielberger question will be completed.
Category
Treatment - Drugs
2
Description
Control group: An hour prior to angiography, the patient's vital signs will be monitored and the demographic and Spilberger questionnaires will be completed, then pads stained with 0.2 ml of normal saline will be attached to the front of the chest and will be inhaled for 20 minutes. The Spielberger control and question will be completed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Roghaye Koohestani
Street address
Shahid Mohammadi Hospital, Shahid Chamran Blvd.
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7001
Email
roghayekoohestani2028@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Timur Aga Molaei
Street address
Research and Technology Dept., Shahid Mohammadi Hospital, Islamic Republic of Iran Blvd.
City
Banda Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 4429
Fax
+98 76 3334 4429
Email
roghayekoohestani2028@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Roghaye Koohestani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Southern Resalat Ave.
City
BandarAbbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7001
Email
roghayekoohestani2028@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Roghaye Koohestani
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Southern Resalat Ave.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7001
Email
roghayekoohestani2028@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Roghaye Koohestani
Position
Masters
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Southern Resalat Ave.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7001
Email
roghayekoohestani2028@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available