1. Home
  2. Approved trials
  3. » فارسی

The effect of lavender aromatherapy on boredom, severity of anxiety, cognitive function, clinical factors in smokers users

Protocol summary

Study aim
Determining the effect of lavender scent on impatience, anxiety intensity, cognitive function, clinical factors in smokers in Kashan city.
Design
A clinical trial with a control group and a sample size of 80 participants, with parallel groups, double-blind, randomized with Trek software and based on the random number table method.
Settings and conduct
This study is an experimental method (pre-test and post-test) and a double-blind intervention. The sample size is 80 people. The selected people will be divided into two groups of 40 people, test and control. In the experimental group, for a period of 15 days, patients are asked to inhale 2% lavender essential oil every night before going to bed. In the control group, distilled water is used to compare the results with the experimental group.
Participants/Inclusion and exclusion criteria
Entry criteria: 1- Willingness of the participants to enter the experiment 2- Age range of 18-49 years old 3- Not having a chronic disease such as mental illness or diabetes, blood pressure or heart disease and hepatitis etc. 4- All people who are smoking Or, not much time has passed since they stopped using them and their Fagerstrom score is at least 4 Exclusion criteria: non-cooperation 2- using any kind of drugs 3- having any newly diagnosed chronic physical disease
Intervention groups
Intervention group: includes 40 participants. Using two drops of lavender essential oil on a cotton gauze and breathing for 20 minutes Control group: includes 40 participants. Distilled water is used to compare the results with the experimental group.
Main outcome variables
Primary outcomes: It includes impatience and cognitive assessment, sleep quality, anxiety intensity and cognitive assessment. Secondary consequences: It includes markers related to blood pressure, blood oxygen levels, and heart rate.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230320057758N1
Registration date: 2023-03-28, 1402/01/08
Registration timing: prospective

Last update: 2023-03-28, 1402/01/08
Update count: 0
Registration date
2023-03-28, 1402/01/08
Registrant information
Name
peyman Esmaili-Shahzade-Ali-Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3457 4191
Email address
esmaeili-p@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-21, 1402/04/30
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender aromatherapy on boredom, severity of anxiety, cognitive function, clinical factors in smokers users
Public title
Investigating the effect of lavender scent on the side effects of smoking
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness of participants to enter the experiment Age range 18-49 years Not having a chronic disease, including mental illness or diabetes, blood pressure or heart disease, hepatitis, etc. All people who are smoking or have not quit smoking for a long time and their Fagerstrom score is at least 4.
Exclusion criteria:
Unwillingness to participate in the study Taking any kind of drugs Any chronic physical disease that is newly diagnosed and interferes with the test results, including diabetes, high blood pressure, etc.
Age
From 18 years old to 49 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the presenters and patients, oil and placebos are placed in separate packages with codes 1 and 2.
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 University of Medical Sciences, Faculty of Medicine, Kashan, Iran
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.245

Health conditions studied

1

Description of health condition studied
Nicotine dependence
ICD-10 code
F17.21
ICD-10 code description
Nicotine dependence, cigarettes

Primary outcomes

1

Description
Boredom score of MSBS questionnaire
Timepoint
Completing the questionnaire before the intervention and on the 15th day of the intervention
Method of measurement
MSBS questionnaire

2

Description
Expression intensity by Hamilton questionnaire
Timepoint
Completing the questionnaire before the intervention and on the 15th day of the intervention
Method of measurement
Hamilton Anxiety Severity Questionnaire

3

Description
Cognitive performance score of MoCA questionnaire
Timepoint
Completing the questionnaire before the intervention and on the 15th day of the intervention
Method of measurement
MoCA Cognitive Function Questionnaire

4

Description
Sleep quality score of Petersborg Sleep Disorder Questionnaire
Timepoint
Completing the questionnaire before the intervention and on the 15th day of the intervention
Method of measurement
Petersburg Sleep Disorder Questionnaire

5

Description
Blood pressure measurement
Timepoint
Measurement before the intervention and day 15 of the intervention
Method of measurement
Blood pressure measuring device

6

Description
Heart rate measurement
Timepoint
Measurement before the intervention and day 15 of the intervention
Method of measurement
Heart rate monitor

7

Description
Blood oxygen measurement
Timepoint
Measurement before the intervention and day 15 of the intervention
Method of measurement
Blood oxygen measuring device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: includes 40 participants. In this group, before the intervention, tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are taken from the participants. Then, patients are given vials containing lavender essential oil, which is provided by Barij Essential Oil Company, and they are asked to put two drops of it on a cotton ball every night before going to sleep for 15 days and breathe slowly for 20 minutes. slow At the end, the intervention tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are received from the participants again.
Category
Treatment - Drugs

2

Description
Control group: includes 40 participants. In this group, before the intervention, tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are taken from the participants. Then vials containing distilled water, which are in the shape and size of the vials of the intervention group, are obtained from Barij Essans Company, are given to the patients and they are asked to drink two drops of them every night before going to bed for 15 days. Put it on cotton and breathe slowly for 20 minutes. At the end, the intervention tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are received from the participants again.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Kashan city
Full name of responsible person
amir ghaderi
Street address
Kashan University of Medical Sciences, Faculty of Medicine
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
peyman.esmaely@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
DR gholamali hamidi
Street address
Kashan University of Medical Sciences, Vice President of Research and Technology
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
hamiidi@yahoo.com
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
Amir ghaderi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Kashan University of Medical Sciences, Faculty of Medicine
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
gaderiam@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir ghaderi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Kashan University of Medical Sciences, Faculty of Medicine
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
gaderiam@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
peyman esmaili
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Toxicology
Street address
Kashan University of Medical Sciences, Faculty of Medicine
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
esmaeili-p@kaums.ac.ir

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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Loading...