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Investigating the effect of Lemon scent on patients before rhinoplasty surgery

Protocol summary

Study aim
Determination and comparison of the average anxiety score of rhinoplasty candidate patients, before and after the intervention in the intervention group Determining and comparing the average anxiety score of rhinoplasty candidate patients, before and after the intervention in the control group Determining and comparing the difference in the average anxiety score before and after the intervention in two intervention and control groups
Design
A controlled clinical trial, double-blind, randomized, on 30 patients, randomization using card number 1 and 2
Settings and conduct
At first, 30 candidates for rhinoplasty in Kashani hospital in Isfahan city, who are undergoing surgery, are selected for easy access. For the random allocation of samples, the researcher will put cards numbered 1 and 2 in an envelope according to the number of subjects, and the patients will be asked to pull a card out of the envelope. Card number 1 is placed in the test group and card number 2 is placed in the control group. In the control group, a liquid of the same color as the essence of the intervention group is used
Participants/Inclusion and exclusion criteria
Healthy sense of smell No history of respiratory disease Insensitivity to herbal essential oils Not taking sedatives
Intervention groups
After it is determined in which group the patient is placed, the intervention is carried out in such a way that, in the intervention group, he inhales 3 drops of Lemon essential oil for 20-30 minutes normally. For the control group, 3 drops of odorless liquid of the same color (water + color of the desired essential oil) is inhaled for 20-30 minutes.
Main outcome variables
Overt anxiety score Latent anxiety score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221101056375N1
Registration date: 2022-11-14, 1401/08/23
Registration timing: prospective

Last update: 2022-11-14, 1401/08/23
Update count: 0
Registration date
2022-11-14, 1401/08/23
Registrant information
Name
maryam amirshekari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4331 6688
Email address
amirshekarimaryam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-16, 1401/08/25
Expected recruitment end date
2022-12-11, 1401/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Lemon scent on patients before rhinoplasty surgery
Public title
The effect of Lemon scent on the anxiety of patients before rhinoplasty surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy sense of smell No history of asthma or chronic obstructive pulmonary disease Insensitivity to herbal essential oils Not taking sedatives Not having mental and anxiety diseases
Exclusion criteria:
Taking sedatives Lack of consent to participate in the study History of respiratory disease History of allergy to lemon essential oil
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized controlled clinical trial study, at first, 30 patients who are candidates for rhinoplasty who are about to be operated on are selected in the form of easy access. The number of subjects will put cards with numbers 1 and 2 in an envelope. And the patients are asked to draw a card from the envelope. Patients with card number 1 will be in the test group and patients with card number 2 will be in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the intervention group, 3 drops of Lemon essential oil were dripped on the medical gauze using a dropper and attached to the patient's neck, and it is recommended to inhale normally for 20-30 minutes. For the control group, 3 drops of odorless liquid of the same color (water + color of desired essential oil) of Lemon essential oil used for the intervention group, are poured on a medical gauze and connected to the patient's collar like the intervention group, and it is recommended for 20 Inhale normally for 30 minutes.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Nursing, Management and Rehabilitation - Isfahan University of Medica
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-10-30, 1401/08/08
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.091

Health conditions studied

1

Description of health condition studied
It is not a disease
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
anxiety
Timepoint
Before the intervention and after the intervention
Method of measurement
Spiegelberger questionnaire

2

Description
The percentage of people whose manifest anxiety questionnaire score is less than 40
Timepoint
Before and after the intervention
Method of measurement
Calculation of the score of the Spiegelberger questionnaire

3

Description
The percentage of people whose overt anxiety questionnaire score is above 60
Timepoint
Before and after the intervention
Method of measurement
Calculation of the score of the Spiegelberger questionnaire

4

Description
The percentage of people whose anxiety questionnaire score is above 60
Timepoint
Before and after the intervention
Method of measurement
Calculation of the score of the Spiegelberger questionnaire

5

Description
The percentage of people whose hidden anxiety questionnaire score is less than 40
Timepoint
Before and after the intervention
Method of measurement
Calculation of the score of the Spiegelberger questionnaire

Secondary outcomes

1

Description
Overt anxiety score
Timepoint
Before and after the intervention
Method of measurement
Spiegelberger questionnaire

2

Description
Latent anxiety score
Timepoint
Before and after the intervention
Method of measurement
Spiegelberger questionnaire

Intervention groups

1

Description
Intervention group: 3 drops of Lemon essential oil from Kashan Barij Essential Oil Company. The main components of Lemon essential oil used include: limonene (68.2%), betapinene (12.8%), gamma terpinene (8.8%) and alpha pinene (2.2%).Using a medical gas dropper 10x10 from Harir Novin Sepahan company, it drips and is connected to the patient's neck and it is recommended to inhale normally for 20-30 minutes.
Category
Prevention

2

Description
Control group: For the control group, 3 drops of odorless liquid of the same color (water + the color of the desired essential oil) of the Lemon essential oil used for the intervention group were poured on a 10 x 10 medical gauze and connected to the patient's collar as in the intervention group, and it is recommended to Inhale normally for 20 to 30 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Maryam Amirshekari
Street address
plate 3،, 5 Pasdaran Alley, second side on the left, Pasdaran St.
City
Jiroft
Province
Kerman
Postal code
78616-15517
Phone
+98 922 329 4125
Email
amirshekarimaryam@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Askari
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
34567789-123
Phone
+98 31 3668 8138
Fax
+98 31 3792 8110
Email
askari@mui.ac.ir
Web page address
https://med.mui.ac.ir/fa/ejtemaei
Grant name
Isfahan Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
70
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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Amirshekari
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
surgery room
Street address
Pasdaran Alley 5,Pasdaran Boulevard,
City
Jiroft
Province
Kerman
Postal code
78616-15517
Phone
+98 34 4331 6688
Email
amirshekarimaryam@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Amirshekari
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
surgery room
Street address
Alley 5,Pasdaran Street
City
Jiroft
Province
Kerman
Postal code
78616-15517
Phone
+98 34 4331 6688
Fax
Email
amirshekarimaryam@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Amirshekari
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
surgery room
Street address
Alley 5, Pasdaran Street
City
Jiroft
Province
Kerman
Postal code
78616-15517
Phone
+98 34 4331 6688
Email
amirshekarimaryam@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
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