Evaluation of the effect of lavender (Lavandula angustifolia) oral drops in changing dental anxiety score in patients referred for endodontic treatment
The effect of oral lavender drops on reducing anxiety in patients referred for endodontic treatment
Design
A clinical trial with a control group with parallel double-blind groups on 64 patients. A table of random numbers was used for randomization.
Settings and conduct
If the patient is accidentally placed in the intervention group, he will receive a disposable plastic cup with a lid, the contents of which are not visible, containing 20 oral drops of lavender extract in 250 ml of water. Patients who are randomly assigned to the control group receive a disposable plastic cup with a lid of the same shape, size, and color that contains 20 drops of water poured into 250 ml of water. Due to the fact that lavender extract has a special smell and aroma, in both groups, we cover the plastic cup lid with lavender extract. After 60 minutes of drinking the solutions, the anxiety questionnaire is completed again by the participants of the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients who need endodontic treatment;
Exclusion criteria: 1. Age under 12 years. 2. Not have a healthy mental state. 3. Has used anti-anxiety medications such as benzodiazepines in the past week. 4. A woman who is pregnant. 5. A breastfeeding woman 6. Have a history of contact dermatitis symptoms after consuming lavender essential oil. 7. Have a history of allergies to the main components of lavender extract, including linalool. 8. Patients who are taking coumarin.
Intervention groups
The study includes two groups of intervention and control. The intervention group receives the main medicine, which is lavender extract. The control group receives water in a glass with same shape and size.
Main outcome variables
Patients' anxiety scores are measured by a modified dental anxiety questionnaire before and after taking medication or placebo.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120908010773N2
Registration date:2021-09-12, 1400/06/21
Registration timing:registered_while_recruiting
Last update:2021-09-12, 1400/06/21
Update count:0
Registration date
2021-09-12, 1400/06/21
Registrant information
Name
Hamid Razavian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1624 3998
Email address
razavian@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of lavender (Lavandula angustifolia) oral drops in changing dental anxiety score in patients referred for endodontic treatment
Public title
The effect of lavender oral drops in anxiety in patients referred for endodontic treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred for endodontic treatment
Exclusion criteria:
Mental problems
Inability to complete the questionnaire
Taking anti-anxiety medications over the past week
Pregnant women
Breastfeeding women
The patient has a history of allergies after consuming lavender
Patient taking coumarin
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method using a table of random numbers is used. In this study, which includes 64 samples, the numbers 00 to 64 are assigned to the samples. Then we randomly select a table point in the row direction. We select numbers smaller than the size of the study population. The selected numbers are in fact the individual code of the community that is selected as the sample. We will continue this until the sample size is complete and reaches the number 64.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants are not aware of the contents of the glass and whether it was a medicine or a placebo. Before the clinical caregiver gives the medication and placebo to the participants, another person performs the steps of pouring the drug and the placebo into the glass, and in this way, the clinical caregiver is blinded. Also, the main researcher of the project has no information about contents of each glass and does not know anything about which group receive placebo and which group receive medicine.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan university of medical science, Hezar jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.837
Health conditions studied
1
Description of health condition studied
Dental anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dental anxiety score in modified dental anxiety survey
Timepoint
Measure anxiety at the beginning of the study and one hour after consuming lavender
Method of measurement
Modified dental anxiety scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One use of 20 drops of oral lavender extract in 250 ml of water
Category
Treatment - Drugs
2
Description
Control group: One use of 20 drops of water poured into a glass containing 250 ml of water.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan faculty of dentistry
Full name of responsible person
Seyed Hamid Razavian
Street address
Soffeh Blv
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3303 3950
Email
razavian@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Hezar jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
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
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
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Hamid Razavian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Soffeh Blv
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2588
Email
razavian@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Hamid Razavian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Soffeh Blv
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2588
Email
razavian@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Hamid Razavian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Soffeh Blv
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2588
Email
razavian@dnt.mui.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as the original outcome information, can be shared
When the data will become available and for how long
The access period will be one year after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Can be used in similar clinical designs
From where data/document is obtainable
Dr. Seyed Hamid Razavian Isfahan School of Dentistry Sofeh St. Contact number 09133314371
What processes are involved for a request to access data/document
A full explanation of the reason for the documents and the contact address must be provided so that it can be sent to the documents within 1 month.