Determining the effect of inhaled aromatherapy with lavender essential oil on patients' anxiety before dental procedures
Design
The present study performed clinical trials with intervention and control groups with parallel, double-blind, and randomized groups on 64 patients
Settings and conduct
The present study is performed on patients under dental procedures in Larestan dental clinics
Participants/Inclusion and exclusion criteria
entry criteria:age over 18 years,Getting a score of over 20 using the spielberger questionnaire and Exit criteria:lung problems,history of allergy to herbal medicines,olfactory disturbance, history of seziure or epilepsy,taking anti- anxiety medications(Banzodiazepines)72 hours before dental procedures
Intervention groups
In the intervention group, 2 drops of lavender essential oil, 2% are poured on the handkerchief by a dropper and the patient inhales it for 20 minutes.
In the placebo group (control), 2 drops of distilled water are poured on the handkerchief by a dropper and the patients inhale the placebo for 20 minutes.
Main outcome variables
Anxiety Scale Questionnaire and Vital signs Checklist
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200521047534N1
Registration date:2020-11-10, 1399/08/20
Registration timing:registered_while_recruiting
Last update:2020-11-10, 1399/08/20
Update count:0
Registration date
2020-11-10, 1399/08/20
Registrant information
Name
Zahra Seifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5224 5009
Email address
z.seifi2010@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-21, 1399/07/30
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhalation aromatherapy with lavender essential oil on anxiety before dental procedures
Public title
Effect of lavender on anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age over 18 years
Getting a score of over 20 using the spielberger questionnaire
Exclusion criteria:
lung problems
history of allergy to herbal medicines
olfactory disturbance
a history of seziure or epilepsy
taking anti- anxiety medications(Banzodiazepines)72 hours before dental procedures
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization is used to balance the number of samples allocated to each study group. According to the volume of the final sample in this study, 8 blocks of 8 are used to allocate participants in each group and the allocation of intervention and control group to letters A and B will be done randomly according to the pre-determined blocks. . Individuals are divided into two groups according to the criteria for entering and leaving the study and according to randomly designed blocks (in each block, 4 individuals for the intervention group and 4 individuals for the control group
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the fact that anxiety is measured subjectively and can be influenced by induction or indoctrination, anxiety measurement will be done in two ways. After designing the random allocation, the lead researcher provides it to the researcher and asks him or her to divide the individuals into two groups according to the random sequence of blocks. At this stage, the patient and the researcher will not be aware of the type of individual group (intervention or placebo) and the type of treatment assigned. For this purpose, prescribing treatment and research will be two separate individuals.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Larestan University of Medical Sciences
Street address
Research Assistant of Larestan University of Medical Science,karmandan Ave,North Gadir Boulivard,New City
City
Larestan
Province
Fars
Postal code
74318-89629
Approval date
2020-05-18, 1399/02/29
Ethics committee reference number
IR.LARUMS.REC.1398.005
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety score in Spielberger questionnaire
Timepoint
before and after intervention
Method of measurement
Anxiety Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2 drops of lavender essential oil, 2% are poured on the handkerchief by a dropper and the patient inhales it for 20 minutes.
Category
Treatment - Other
2
Description
Control group: 2 drops of distilled water are poured on the handkerchief by a dropper and the patients inhale the placebo for 20 minute
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Dental Clinic
Full name of responsible person
Zahra Seifi
Street address
Mehr clinic, Helal Ahmar Ave,New City,Lar,Fars Province
City
Lar
Province
Fars
Postal code
74319-75566
Phone
+98 71 5225 3152
Email
z.seifi2010@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr zahra keshtkaran
Street address
Research Assistant of Larestan University of Medical Science,Karmandan Ave,North Ghadir Boulivard,New City,Larestan,Fars
City
Larestan
Province
Fars
Postal code
74318-89629
Phone
+98 71 5234 2877
Email
z.seifi2010@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
Zahra Seifi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
karmandan Ave,North Gadir Boulivard,New City
City
Lar
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5009
Email
z.seifi2010@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Zahra
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
karmandan Ave,North Gadir Boulivard,New City
City
Lar
Province
Fars
Postal code
74318-89629
Phone
+98 71 5225 5009
Email
z.seifi2010@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Zahra Seifi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
karmandan Ave,North Gadir Boulivard,New City
City
Lar
Province
Fars
Postal code
89629-74318
Phone
+98 71 5225 5009
Email
z.seifi2010@yahoo.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
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
It can be shared by unidentifiable participants
When the data will become available and for how long
Access begins a year after the publication of results
To whom data/document is available
People who are working in the academic and scientific institutions
Under which criteria data/document could be used
It needs the agreement of Larestan Medical School
From where data/document is obtainable
zahra seifi, faculty member of larestan medical school, z.seifi2010@yahoo.com, tell phone:07152255278, cell phon number:09177827970
What processes are involved for a request to access data/document
Written and formal request to the vice chancellor for research of Larestan University of Medical Sciences