Determining and comparing the effects of lavender and chamomile scents on reducing anxiety in patients undergoing angiography.
Design
The clinical trial has a control group with parallel and randomized groups, and Randomization Maine software was used for randomization.
Settings and conduct
The population studied in this study includes all patients who are candidates for angiography with moderate to severe anxiety, referring to Prophet Azam Hospital, Bandar Abbas in 1403. The relevant intervention will be performed in the angiography department of Prophet Azam Hospital.
After assigning individuals to groups, the level of latent and overt anxiety of individuals will be measured using the Spielberger questionnaire, and then 20 minutes after the intervention, the Spielberger questionnaire will be completed and collected again to measure the anxiety of the sample individuals.
Participants/Inclusion and exclusion criteria
1- Having informed consent
2- Age range 18 to 65 years
3- Having full consciousness
4- Absence of any allergy to medicinal plants
5- Patients who are candidates for coronary angiography for the first time
6- No other invasive procedures before angiography
7- Absence of taking sedatives 4 hours before the intervention
Intervention groups
About an hour before angiography, for the lavender aromatherapy group, 2 drops of 10% lavender essential oil will be poured onto a piece of cloth and pinned 20 centimeters from the patients' noses. In the chamomile aromatherapy group, the same procedure will be performed, and in the placebo group, the same procedure will be performed with distilled water. Then, immediately 20 minutes after the intervention, the patients' anxiety level will be measured again, and finally, the results of the interventions before and after the intervention will be analyzed and compared.
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250111064343N1
Registration date:2025-03-10, 1403/12/20
Registration timing:prospective
Last update:2025-03-10, 1403/12/20
Update count:0
Registration date
2025-03-10, 1403/12/20
Registrant information
Name
Niloofar Rabani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3235 6359
Email address
niloo.rbn1998@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-05, 1404/01/16
Expected recruitment end date
2025-06-06, 1404/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of lavender and chamomile scent on anxiety in patients who are candidates for angiography
Public title
Investigating the effect of aromatherapy on the anxiety of patients who are candidates for angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent
Age range from 18 to 65 years
Having complete alertness
Absence of any allergy to medicinal plants
Candidate patients for coronary angiography for the first time
Failure to perform other invasive procedures before angiography (such as echocardiography through the esophagus)
Absence of valvular heart disease, any olfactory and respiratory problems, drug addiction, liver and kidney problems.
Not taking sedative drugs 4 hours before the intervention
Exclusion criteria:
Unwillingness to participate in the study
History of any confirmed mental illness, such as depression and anxiety
The occurrence of any cardiac dysrhythmias and changes in vital signs and hemodynamics
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method of this study is non-probability. In this way, patients who meet the inclusion criteria and complete the consent form to participate in the study will be considered as the study sample of this study until the desired number of samples is completed. Then, using the random block method (selection of 10 blocks of 15), we allocate the sample individuals to one of the three study groups (lavender, chamomile, or placebo) according to the random sequence table extracted in the Randomization Maine software at the Internet address https://www.randomizer.org/.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single-blinding in this study means that the participants simply do not know which scent they will be exposed to. (While the patients are able to identify the scents, they do not know which particular scent is the active intervention being tested.)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Nursing and Midwifery Faculty, Hormozgan University of Medical Sciences , Beginning of Imam Hossein Boulevard
City
Bandarabbas
Province
Hormozgan
Postal code
7919693116
Approval date
2025-01-08, 1403/10/19
Ethics committee reference number
IR.HUMS.REC.1403.307
Health conditions studied
1
Description of health condition studied
Anxiety of angiography patients
ICD-10 code
I25.10
ICD-10 code description
Atherosclerotic heart disease of native coronary artery without angina pectoris
Primary outcomes
1
Description
Anxiety level of angiography candidate patients
Timepoint
Measuring the anxiety level of angiography candidate patients before the intervention and twenty minutes after the intervention
Method of measurement
Spielberger's overt and covert anxiety test questionnaire, whose validity and reliability have been confirmed
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention group (aromatherapy with lavender essential oil): After assigning individuals to the intervention and placebo groups, the level of latent and overt anxiety will be measured using the Spielberger questionnaire. The second step: About an hour before angiography, for the lavender aromatherapy group, 2 drops of 10% lavender essential oil (provided by Barij Essential Oil Company) will be poured onto a 10 x 10 cm piece of cloth using a dropper and pinned to the patients' shirts 20 cm from their noses. Then, immediately 20 minutes after the intervention, the patients' level of anxiety will be measured again using the Spielberger questionnaire, and the data will be collected and analyzed. Finally, the results of the interventions between the groups, as well as before and after the intervention, will be analyzed and compared.
Category
Prevention
2
Description
Intervention group: Second intervention group (aromatherapy with chamomile essential oil): After assigning individuals to the intervention and placebo groups, the level of latent and overt anxiety will be measured using the Spielberger questionnaire. The second step is that about an hour before angiography, for the aromatherapy with chamomile essential oil group, 2 drops of 10% chamomile essential oil will be poured onto a 10 x 10 cm piece of cloth using a dropper and pinned to the patients' shirts at a distance of 20 cm from their noses. Then, immediately 20 minutes after the intervention, the patients' level of anxiety will be measured again using the Spielberger questionnaire, and data will be collected and analyzed. Finally, the results of the interventions between the groups, as well as before and after the intervention, will be analyzed and compared.
Category
Prevention
3
Description
Control group: (Aromatherapy with distilled water): After assigning individuals to the intervention and placebo groups, the level of latent and overt anxiety will be measured using the Spielberger questionnaire. The second step is that about an hour before angiography, for the placebo group, 2 drops of distilled water will be poured onto a 10 x 10 cm piece of cloth using a dropper and pinned to their shirt 20 cm from the patients' noses. Then, immediately 20 minutes after the intervention, the patients' level of anxiety will be measured again using the Spielberger questionnaire, and the data will be collected and analyzed. Finally, the results of the interventions between the groups, as well as before and after the intervention, will be analyzed and compared.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Payambar azam hospital
Full name of responsible person
Aref Faghih
Street address
Islamic Republic Boulevard, opposite the Municipality of District 3, payambar azam's Educational and Medical Complex
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 930 185 0138
Email
niloo.rbn1998@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Shahram Zare
Street address
Beginning of Imam Hossein Boulevard, Hormozgan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
info@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Niloofar Rabbani
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Beginning of Imam Hossein Boulevard, Hormozgan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Bandar abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 930 185 0138
Email
niloo.rbn1998@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Aref Faghih
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Beginning of Imam Hossein Boulevard, Hormozgan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Bandar abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3128 5022
Email
aref_faghih@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Niloofar Rabbani
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Beginning of Imam Hossein Boulevard , Hormozgan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Bandarabbas
Province
Hormozgan
Postal code
7919693116
Phone
0098763347000
Email
niloo.rbn1998@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only information about the outcome
When the data will become available and for how long
Since 1403
To whom data/document is available
The data will be available to all healthcare researchers.
Under which criteria data/document could be used
It will be used for research and educational purposes.
From where data/document is obtainable
Ms. Niloofar Rabbani, a senior student of surgical nursing at Hormozgan University of Medical Sciences, can be reached via email at niloo.rbn1998@gmail.com and phone number 09301850138.
What processes are involved for a request to access data/document
Access to the data file will be possible by sending a request to the author's email.