Protocol summary

Study aim
A Comparing the effects of violet and chamomile essential oils on the sleep quality of patients with acute coronary syndrome
Design
The clinical trial is double-blind and randomized according to table number. The sample size is 70 people who were divided into two groups of 35 people (2 intervention groups). Both groups receive usual care for the treatment of acute coronary syndrome, but the intervention groups, in addition to usual care, undergo aromatherapy intervention with chamomile essential oil and violet essential oil.
Settings and conduct
This study is a single-blind clinical trial. The sample of the study is patients with acute coronary syndrome hospitalized in the CCU department of Shahid Beheshti Hospital in Kashan. Patients participating in the study will be divided into two groups of 30 intervention and one control group. The data collection tool is the demographic characteristics questionnaire and the Pittsburgh sleep quality scale.
Participants/Inclusion and exclusion criteria
Entry requirements: written consent; ; age 35-70 years; Literacy for reading and writing; has not used complementary treatments for at least one month before; Conditions for non-entry: absence of addiction, no history of respiratory allergies, and sensitivity to flowers and plants; the presence of olfactory disorders; Not using any drugs that affect sleep during the study, except for the drug treatment prescribed by the department
Intervention groups
Intervention group: patients with acute coronary syndrome who refer to the heart department of the hospital and undergo aromatherapy intervention with chamomile essential oil and violet essential oil, and the patient is asked to place cotton on the palm and take ten deep breaths, then with a pin It is installed on the patient's clothes in the direction of the nostril
Main outcome variables
Sleep quality,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240701062290N1
Registration date: 2024-08-22, 1403/06/01
Registration timing: registered_while_recruiting

Last update: 2024-08-22, 1403/06/01
Update count: 0
Registration date
2024-08-22, 1403/06/01
Registrant information
Name
Zhara Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 7603
Email address
rahimi1728@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-15, 1403/04/25
Expected recruitment end date
2024-11-15, 1403/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the effects of violet and chamomile essential oils on the sleep quality of patients with acute coronary syndrome admitted to the cardiac intensive care unit
Public title
A Comparison of the effects of violet and chamomile essential oils on the sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Acquiring and signing the informed consent form A score of 5 or more on the Pittsburgh Sleep Disorder Questionnaire Being in the age range of 35 to 70 years
Exclusion criteria:
Not having known mental illness according to the file Absence of known diseases affecting the sense of smell and healthy sense of smell according to the patient Not using any drugs that affect sleep during the study, except for the drug treatment prescribed by the department Absence of addiction Not having a history of respiratory allergy, asthma, allergic rhinitis and allergy to violet and chamomile and other known herbal substances according to the patient.
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, simple randomization method is used to implement random allocation. In this way, we prepare 60 cards with the same appearance and specify the number or code 1 on 30 cards, which identifies the "chamomile essential oil intervention" group. And on the other 30 cards, the number or code 2 is written, which specifies the "Violet essential oil intervention" group. Each person who is eligible to enter the study then randomly selects one of these cards with the code written on it, thereby randomly assigning patients to each group without knowing the trial participants. Learn about the nature of numbers. . 1 or 2 be aware of the type of intervention to be determined.
Blinding (investigator's opinion)
Double 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
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan - Qutb Rawandi Boulevard - University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2024-06-02, 1403/03/13
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1403.059

Health conditions studied

1

Description of health condition studied
Acute ischemic heart disease, unspecified
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified

Primary outcomes

1

Description
sleep quality
Timepoint
Measurement of sleep quality after essential oil therapy intervention
Method of measurement
Petersburg Sleep Quality Questionnaire (PSQI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: pour three drops of chamomile essential oil of Iran Kazmed Company on the cotton and ask the patient to put the cotton on the palm of the patient and take ten deep breaths and then attach the pin to the patient's clothes towards the nostril. until the next morning
Category
Treatment - Other

2

Description
Intervention group: put three drops of violet essential oil from Company Iran Cosmed on the cotton, the patient is asked to place the cotton on the patient's palm and take ten deep breaths, then it is attached to the patient's clothes with a pin in the direction of the nostril until the next morning.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Dr. Seyed Ramin Madani
Street address
Kashan- Qutb Rawandi Blvd. Martyr Dr. Beheshti Medical Education Center
City
Kashan
Province
Isfehan
Postal code
8715973447
Phone
+98 31 5500 9999
Email
beheshtihospital@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Somia Nadi
Street address
Kashan - 5th kilometer of Qutb Rawandi Blvd. - Kashan University of Medical Sciences - Research Vice-Chancellor
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9338
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Zahra Rahimi
Position
Special care master's student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences - Faculty of Nursing and Midwifery
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9392
Email
nursing@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghadosi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences - Faculty of Nursing and Midwifery
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9392
Email
rahimi1728@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Rahimi
Position
Special care master's student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences - Faculty of Nursing and Midwifery
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 919 132 4044
Email
nursing@kaums.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
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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