Comparing of the Effectiveness of orange and lemon essential oil aromatherapy on sleep quality and physiological parameters of patients with Acute Coronary Syndrome (ACS): A Clinical Trial Study
Determining the Comparative Effect of Orange and Lemon essential oil aroma therapy on Sleep Quality and Physiological parameters of patients with Acute Coronary Syndrome
Design
The clinical trial has a three-way blinded control group and randomized by random table number method. The sample size is 160 people who are divided into four groups of 40 people (3 intervention groups and 1 control group). Both groups receive routine care for the treatment of acute coronary syndrome, but in addition to routine care, the intervention groups are subjected to aromatherapy intervention with orange, lemon and orange and lemon essence.
Settings and conduct
This is a Clinical Trial study that will be conducted in the heart department of Shahid Madani Hospital in Khorram Abad.The patients participating in the study, and then they will be divided into three groups of 40 intervention and one control group. The data collection tool is the questionnaire of demographic characteristics and the Petersburg Sleep Quality scale and the Saadat monitoring device. This study will be triple blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria The research units are suffering from Acute Coronary Syndrome according to the diagnosis of a cardiologist, Be aware of time place people,The research units have not used complementary treatments for at least one month before؛ Exclusion criteria history of taking psychoactive and sedative drugs
Intervention groups
Intervention group: Patients with Acute Coronary Syndrome who refer to the heart department and are subjected to aromatherapy intervention with Orange and Lemon essential oil with an oxygen mask. Control group: There are patients with Coronary Syndrome who are undergoing routine treatments and aromatherapy intervention is not performed for them.
Main outcome variables
Sleep Quality, Physiological Parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240319061339N1
Registration date:2024-04-06, 1403/01/18
Registration timing:prospective
Last update:2024-04-06, 1403/01/18
Update count:0
Registration date
2024-04-06, 1403/01/18
Registrant information
Name
Mehran Naghibeiranvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 1100
Email address
m.nbeuranvand@khoiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of the Effectiveness of orange and lemon essential oil aromatherapy on sleep quality and physiological parameters of patients with Acute Coronary Syndrome (ACS): A Clinical Trial Study
Public title
Comparing of the effectiveness of orange and lemon essential oil aroma therapy on sleep quality and physiological parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The research units have full consent to participate in the study
The research units are suffering from acute coronary syndrome according to the diagnosis of a cardiologist
Be aware of time, place and people
No known mental problems
The research units have not used complementary treatments for at least one month before
Exclusion criteria:
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
In the present study, participating patients, clinical caregivers (nurses), and data analysts were kept blind in the study. None of the participants know which intervention or control group they belong to and only know that they are participating in the research. Also, the nurses who are responsible for caring for the patients under study do not know the type of intervention or patient control group. Finally, the data analyzer will not know the type of patient group and the data will be provided as a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University,Borujerd Branch
Street address
Vice Chancellor for Medical Sciences.Islamic Azad University Borujerd Branch.Modares Square, Modares st, Borojerd
City
Borujerd
Province
Lorestan
Postal code
6915136111
Approval date
2023-05-29, 1402/03/08
Ethics committee reference number
IR.IAU.B.REC.1402.041
Health conditions studied
1
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I20.0
ICD-10 code description
Unstable angina
2
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
121
ICD-10 code description
Acute transmural myocardial infarction of anterior wall
3
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
121.1
ICD-10 code description
Acute transmural myocardial infarction of inferior wall
4
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
121.2
ICD-10 code description
Acute transmural myocardial infarction of other sites
5
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
121.3
ICD-10 code description
Acute transmural myocardial infarction of unspecified site
6
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
121.4
ICD-10 code description
Acute subendocardial myocardial infarction
7
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
121.9
ICD-10 code description
Acute myocardial infarction, unspecified
Primary outcomes
1
Description
Information obtained on the quality of sleep by the Petersburg scale
Timepoint
Measurement of the quality of sleep after aromatherapy intervention
Method of measurement
Petersburg sleep quality t scale
2
Description
Information on the physiological parameters by the Saadat monitor device
Timepoint
Measurement of physiological parameters after aromatherapy intervention
Method of measurement
Saadat monitor device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: They will receive orange essential oil through an oxygen mask
Category
Treatment - Other
2
Description
Intervention group 2: They will receive lemon essential oil through an oxygen mask
Category
Treatment - Other
3
Description
Intervention group 3: They will receive the combined essence of orange and lemon through an oxygen mask
Category
Treatment - Other
4
Description
Control group:In the control group, there will be no intervention other than routine treatments.
Ayatollah Kamalvand University Complex, 5km of Khorramabad-Tehran road
City
Khorramabad
Province
Lorestan
Postal code
6817816645
Phone
+98 66 3312 2500
Email
m.nbeuranvand@khoiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Reza Mirderikvand
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ayatollah Kamalvand University Complex., 5km of Khorramabad Tehran Road
City
Khorramabad
Province
Lorestan
Postal code
6817816645
Phone
+98 66 3312 2500
Email
mehranbeiranvandmsc@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Meharn Naghi Beiranvand
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Kamalvand University Complex., 5 km Khorramabab Tehran Road
City
Khorramabad
Province
Lorestan
Postal code
6817816645
Phone
009866331200
Email
m.nbeuranvand@khoiau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehran Naghi Beiranvand
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Kamalvand University Complex., 5 km of Khorramabad Tehran Road
City
Khorramabad
Province
Lorestan
Postal code
6817816645
Phone
+98 66 3312 1100
Email
m.nbeuranvand@khoiau.ac.ir
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
The data is kept confidential by the researcher and provided to the study participants if desired. Data analysis is presented in the form of tables and charts..
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available