Determining the effect of aromatherapy with peppermint essential oil on pain and Hemodynamic parameters in patients with acute coronary syndrome (ACS)
Design
The current study is a randomized clinical trial with two groups (intervention and control). The patients who are eligible for the study are entered into the study using the available method and are randomly assigned to two groups of mint and placebo using the block method (blocks of four and with an allocation ratio of 1:1 using a random table of numbers). .
Settings and conduct
Subjects will be controlled and intervened into two equal groups using block randomization method. Aromatherapy will last 20 minutes. Complementary tool is performed after aromatherapy. This study will be conducted in the hospitals of Qom University of Medical Sciences
Participants/Inclusion and exclusion criteria
awareness of full consciousness,
Age range 18-60 years
Absence of valvular heart disease
Serious illness
Vision, hearing, and smell problems
No damage and allergic problems
No drug use
Absence of kidney problems
Not taking sedatives 4 hours before the intervention
The absence of mental illness causes problems, stress, stress.
Intervention groups
In the control group, the patients will be treated with a non-absorbent eye pad with 0.2 ml of normal saline for 20 minutes, and for the intervention group, the same steps will be performed in another room, but instead of normal saline, the peppermint essential oil of Barij Essance Company will be used. 0.2 ml with a concentration of 100% is used on the pads, and in both groups the desired pads are attached to the clothes of the patients in the chest area by a pin.
Main outcome variables
pain
Hemodynamic parameters
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221205056718N1
Registration date:2022-12-25, 1401/10/04
Registration timing:registered_while_recruiting
Last update:2022-12-25, 1401/10/04
Update count:0
Registration date
2022-12-25, 1401/10/04
Registrant information
Name
Hossein Sharafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3197 1087
Email address
hsharafi@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of aromatherapy with peppermint essential oil on pain and Hemodynamic parameters in patients with acute coronary syndrome (ACS)
Public title
effect of aromatherapy with peppermint essential oil on pain and Hemodynamic parameters in patients with acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Full consciousness
Age range 18-60 years
Absence of valvular heart disease
Severe disease conditions
Any vision, hearing, or smell disorder
Absence of respiratory and allergic problems
No drug addiction
Absence of liver and kidney problems
Not taking sedatives 4 hours before the intervention
No history of any confirmed mental illness such as depression, anxiety, stress
Exclusion criteria:
Sudden occurrence of any severe changes in vital signs and the presence of dangerous cardiac dysrhythmias in patients
Unwillingness to continue participating in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who are eligible for the study are entered into the study using the available method and are randomly assigned to two intervention and control groups using the block method (blocks of four and with an allocation ratio of 1:1 using a random number table). . For example, the first four participants enrolled form the first block and the next four form the next block, and so randomization occurs within blocks, so with blocks of size four there are six possible patterns: AABB, ABAB, ABBA , BAAB, BABA, and BBAA, each block is randomized based on one of these six patterns, and the patterns are chosen randomly and generally independently from block to block.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Qom University of Medical Sciences
Intervention group: Peppermint essential oil of Barij company is 0.2 ml of 100% essential oil that they inhale on the eye pads. Mint essential oil and placebo with similar appearance produced by Barij Essan Daru Company are placed in dark bottles with similar sizes and shapes. Aromatherapy for the control group and the intervention group in different places and periods of different uses related to acute stress, treatment, hemodynamic treatments and the intensity of chest pain before aromatherapy (time 1), 5 (time 2) and 15 (time) 3) minutes, 30 minutes after aromatherapy (time 4) after the first stage of aromatherapy, then after 30 minutes (1 hour of aromatherapy) the numbers of the study will be measured (time 5) and the second stage of aromatherapy The patient will be exposed to aromatherapy for 20 minutes. Changes in the study will be recorded at 5 (time 6) and 15 (time 7) and 30 minutes after the second phase of aromatherapy (time 8).
Category
Treatment - Drugs
2
Description
In the control group, the patients will be treated with a non-absorbent eye pad with 0.2 ml of normal saline for 20 minutes, and for the intervention group, the same steps will be performed in another room, but instead of normal saline, the peppermint essential oil of Barij Essance Company will be used. 0.2 ml with a concentration of 100% is used on the pads, and in both groups the desired pads are attached to the clothes of the patients in the chest area by a pin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom Shahid Beheshti Hospital
Full name of responsible person
Majid Moghadam
Street address
Qom - Shahid Beheshti Blvd.
City
qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2824
Fax
+98 25 3612 2855
Email
bmc@muq.ac.ir
Web page address
https://bmc.muq.ac.ir/
2
Recruitment center
Name of recruitment center
Khyerin Salamat educational research and therapeutic complex
Full name of responsible person
Javad Hakim Elahi
Street address
Qom - Shahid Del Azar St
City
qom
Province
Ghoum
Postal code
7335537158
Phone
+98 25 3721 1061
Email
Nekoeihospital@muq.ac.ir
Web page address
https://nekuei.muq.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mehdi Mesri
Street address
Qom - Shahid Lavasani St. (Saheli) - Qom University of Medical Sciences and Healthcare Services
City
qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1111
Fax
+98 25 3770 6470
Email
hsharafi@muq.ac.ir
Web page address
https://muq.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Sharafi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qom University of Medical Sciences ,pardisan
City
Qom
Province
Ghoum
Postal code
3749153434
Phone
009892531971087
Email
h_sharafi68@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Sharafi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardisan,Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3749153434
Phone
+98 25 3197 1087
Email
h_sharafi68@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Sharafi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardisan.Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3749153434
Phone
+98 25 3197 1087
Email
h_sharafi68@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The second half of 1402
To whom data/document is available
There is no restriction on access to the results
Under which criteria data/document could be used
There are no restrictions after de-identifying people