assessment effectiveness of lavender essence on anxiety due to tooth extraction
Design
In this control randomized clinical trial single blinded with parallel group 60 patients come to Kermanshah dental college who have inclusion criteria assign to the groups.
Settings and conduct
60 patients who come to Kermanshah dental college for tooth extraction allocate 2 groups with randomized number chart. give to patients anxiety questionnaire test to complete then if allocate even number to patient give lavender to smell and patients with odd number give almond oil to smell .patients smell odors on gauze for 20 minutes and then complete that questionnaire again.
Participants/Inclusion and exclusion criteria
inclusion criteria:1-patients between 18-65 years 2-who candidate for extraction anterior or posterior tooth
extrusion criteria:1- impact tooth 8 surgery 2-pregnancy 3- routine smoking ( minimum 1 Cigarette per day) 4-use special drugs such as sedatives (past 24 hours )5-any history of cardiac disease 6-uncontrolled hypertension(over 180 mm hg) 7-Sinusitis and Rhinitis and any thing effect on olfactory system
Intervention groups
1- control :almond oil 2- intervention: Lavender essence
Main outcome variables
Amount of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190920044824N1
Registration date:2019-12-19, 1398/09/28
Registration timing:retrospective
Last update:2019-12-19, 1398/09/28
Update count:0
Registration date
2019-12-19, 1398/09/28
Registrant information
Name
Fatemeh Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3729 2072
Email address
fatemeh.rezaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-13, 1398/06/22
Expected recruitment end date
2019-11-20, 1398/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of lavender essence on patient s anxiety due to tooth extraction ,randomized controlled trial
Public title
Determine effect of lavender's essence on patients anxiety due to tooth extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient between 18-65 years
patient who candidate for extraction one anterior or posterior tooth
Exclusion criteria:
impact 8tooth surgery
pregnancy
routine smoking (minimum one cigarette per day)
use sedative drugs during past 24 hours
any exist history of particular systemic disease like uncontrolled hyper tension (over 180 mm hg) ,history of any cardiac disease ,sinusitis ,rhinitis ,any thing effects on olfactory system
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Use Excel soft ware for produce three digit random numbers. based on the last digit on the right patient's assign to the groups.if the last digit on the right be 1-4 give blue tube to the patient and if the last digit on the right be 5-8 give red tube to the patient and will be ignored if be 0 or 9 and produce another new number for the patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
Groups assignment phydisian and outcome assessment physician who evaluate anxiety after intervention dont aware of groups allocation .just pharmacologist be aware of tube's content and patients cant be blind beacause of lavender 's odour.
Placebo
Used
Assignment
Parallel
Other design features
placebo is almond oil.each group smell the odour 20 minutes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of kermanshah university of medical sciences
Street address
Ethics committee,department of research and technology central building ,shahid beheshti blvd
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-10-13, 1398/07/21
Ethics committee reference number
IR.KUMS.REC.1398.693
Health conditions studied
1
Description of health condition studied
patient s anxiety due to tooth extraction
ICD-10 code
F41.9
ICD-10 code description
Anxiety
Primary outcomes
1
Description
patient anxiety due to tooth extraction
Timepoint
before and after smell odors
Method of measurement
Beck anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group 2 drop pure lavender essence which made by pharmacologist on gauze give to patients and they smell for 20 minutes and then complete Beck anxiety questionnaire again .
Category
Treatment - Other
2
Description
Control group: in this group 2 drop almond oil on gauze (with no color and smell )give to patients and they smell for 20 minutes and then complete Beck anxiety questionnaire .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah Dental University
Full name of responsible person
Fatemeh Rezaei
Street address
shariati st.
City
kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3727 7030
Email
fatemeh.rezaei@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice chancellor for research and technology ,kermanshah university of medical sciences,shahid beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3729 6591
Email
Faridnajafi@kums .ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Baharsadat Ghasemiyan
Position
Under graduated student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
The school of Dentistry, shariati st.
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3727 7030
Email
WWW.bahar2017ghasemiyan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Rezaei
Position
Assistant Professor of Oral Disease Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral Disease ,The School of Dentistry ,kermanshah university of medical siences,shariati st.
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3729 6910
Email
fatemeh.rezaei@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Bahar Sadat Ghasemiyan
Position
Under Graduated student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
The School of Dentistry ,Kermanshah University of Medical sciences,Shariati st.
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3727 7030
Email
www.bahar2017ghasemiyan@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