The Effect of Aroma inhalation Melissa officinalis on Anxiety level and Physiological Parameters of patients Undergoing Coronary Angiography - Kordkoy Heart Hospital –Winter 2020
Determining the effect of Aroma inhalation Melissa officinalis on anxiety level and physiological parameters of patients undergoing coronary angiography
Design
A clinical trial with the control group, randomized, phase 3 on 72 patients. A four-block random assignment will be used to assign samples to groups.
Settings and conduct
After that, people are divided into two groups of control and case of 36 people by simple randomization method.
Intervention in the intervention group will be aromatherapy with Melissa officinalis essential oil (essential oil that will be prepared by the plant company of essential oil will be used). Three drops of essential oil are placed on 2. 2 pieces of gas and attached to the patient's collar for 20 minutes. In the control group, distilled water will be used instead of lemon balm essential oil.
Participants/Inclusion and exclusion criteria
Inclusion criteria will be: age over 35 years; Candidate angiography patients; Having informed consent and completing a written consent; Having a healthy sense of smell
Inclusion criteria: previous angiography history; previous diagnosis of valvular heart disease; mental health problems; history of plant allergies
Intervention groups
After that, people are divided into two groups of control and case of 36 people by simple randomization method.
Intervention in the intervention group will be aromatherapy with Melissa officinalis essential oil (essential oil that will be prepared by the plant company of essential oil will be used). Three drops of essential oil are placed on 2. 2 pieces of gas and attached to the patient's collar for 20 minutes. In the control group, distilled water will be used instead of lemon balm essential oil.
The Effect of Aroma inhalation Melissa officinalis on Anxiety level and Physiological Parameters of patients Undergoing Coronary Angiography - Kordkoy Heart Hospital –Winter 2020
Public title
The Effect of Aroma inhalation Melissa officinalis on anxiety before cardiac angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 35 years
Patients undergoing angiography
Having a healthy sense of smell
Having informed consent and completing a written consent
Exclusion criteria:
History of previous coronary angiography
Previous diagnosis of heart valve disease
Having mental health problems
History of allergy to plants
Age
From 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are divided into control and case groups by simple randomization method.
Samples will be selected as available. A four-block random assignment will be used to assign samples to groups. Therefore, we will have 6 blocks that the order of allocating samples in groups is (AABB-ABAB-ABBA-BAAB-BABA-BBAA). Each of the blocks is assigned numbers from one to six. Randomly selected from 1 to 6 digits. Select the block corresponding to the desired number and assign the patients to the two groups according to the block.
Write numbers 1 to 6 on a piece of paper and put them in the glass. Randomly, one of the papers will be selected from the glass. Corresponding to the number on the sheet, the desired block of text is taken out and according to the permutations of the block, samples are assigned to two groups(In the intervention group, and in the control group).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
NO
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Phalsaphy complex, Shast kola Road
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2021-02-01, 1399/11/13
Ethics committee reference number
IR.GOUMS.REC.1399.340
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
Once before exposure and the second time for the third minute of aromatherapy
Method of measurement
Stilberger Questionnaire
Secondary outcomes
1
Description
Hemodynamic changes
Timepoint
Once before exposure and the second time for the third minute of aromatherapy
Method of measurement
Monitoring device
2
Description
Respiratory rate
Timepoint
Once before exposure and the second time for the third minute of aromatherapy
Method of measurement
Monitoring device
Intervention groups
1
Description
Intervention group: Three drops of lemon balm essential oil are placed on a 2 × 2 piece of gas and will be attached to the patient's collar for 20 minutes.
Category
Treatment - Drugs
2
Description
Control group: Three drops of distilled water are placed on a 2 × 2 piece of gas and will be attached to the patient's collar for 20 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kordkoy Heart Hospital
Full name of responsible person
Mehdi Zahedi
Street address
Jangal Street, above Amir Al-Momenin Square
City
Kordkuy
Province
Golestan
Postal code
48818 99441
Phone
+98 17 3234 3969
Fax
Email
dr.kolaangi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Vice-chancellor of Research and Technology of Gorgan University
Street address
Vice-chancellor of Research and Technology, Gorgan University of Medical Sciences, 5 Km Gorgan, Sari Road
City
Gorgan
Province
Golestan
Postal code
4991555876
Phone
+98 17 3243 0310
Email
Info@goums.ac.ir
Web page address
http://goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Kolangi
Position
Specialist faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Gorgan university of medical science ,Hirkan blve
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1653
Email
dr.kolaangi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Kolangi
Position
Specialist faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Gorgan university of medical science ,Hirkan blve
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1653
Email
dr.kolaangi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Kolangi
Position
Specialist faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Gorgan university of medical science ,Hirkan blve
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1653
Email
dr.kolaangi@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