The purpose of this study is to research about the effects of aromatherapy inhalation on anxiety level of children referred for dental treatment.
This single-blind clinical trial is going to be done on 34 Children , referred for dental treatment. Inclusion criteria : Healthy children between 8-10 years old, having ability to read and write, Exclusion criteria : Children under 8 or above 10 having any kind of disease. Patients are divided into two groups of 17,Group 1: In the first visit, they are going to be exposed to lavender odor, in the next visit, their dental treatment is going to be done without inhaling Lavender. Group 2: In the first visit, they wont be exposed to lavender odor but in the next one they will. During the time the patient is supposed to be exposed to Lavender smell, after 10-15 minutes of inhaling the Lavender , they are asked to fill out the CFSS-DS questionnaire in the waiting room. The child's behaviour will also be evaluated by a paedodontist during the treatment by frankle scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022712638N1
Registration date:2013-06-13, 1392/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-13, 1392/03/23
Registrant information
Name
Sanaz Tahmourespour
Name of organization / entity
Islamic Azad University of Khorasgan ( Isfahan) Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4001
Email address
sanaz_t62@yahoo.com
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Khorasgan ( Isfahan ) Branch
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender oil smell on the children's anxiety under dental treatments
Public title
The effect of lavender oil smell on children's anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Healthy children; Children with age between 8-10 years; Having ability to read and write
Exclusion criteria : Children with any kind of disease; children with age under 8 or above 10 years.
Age
From 8 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University of Khoragan( Isfahan) Branch
Street address
Islamic Azad University of Khorasgan, University Blvd., Arghavanieh, Eastern Jei Ave.
City
Isfahan
Postal code
٨١٥٥١٣٩٩٩٨
Approval date
2012-05-26, 1391/03/06
Ethics committee reference number
91030609507
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F40.2
ICD-10 code description
Specific (isolated) phobia
Primary outcomes
1
Description
Anxiety
Timepoint
10 to 15 minutes
Method of measurement
CFSS-DS questionnaire
Secondary outcomes
1
Description
The ability to accept treatment
Timepoint
One to two week
Method of measurement
Frankle scale
Intervention groups
1
Description
Intervention group : exposure to the lavender odor for 10 to 15 minutes, we pour 5 drops of lavender oil in the aerator to let it's smell flow in the air.
Category
Treatment - Drugs
2
Description
Control group : Dental treatment without any intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
IslamicAzad University of Khorasgan(Isfahan)Branch
Full name of responsible person
Sanaz Tahmourespour
Street address
Islamic Azad University of Khorasgan, University Blvd., Arghavanieh, Eastern Jei Ave.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
IslamicAzad University of Khorasgan(Isfahan) Branch
Full name of responsible person
Sanaz Tahmourespour
Street address
Islamic Azad University of Khorasgan, University Blvd., Arghavanieh, Eastern Jei Ave.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
IslamicAzad University of Khorasgan(Isfahan) Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University of Khorasgan(Isfahan) Branch
Full name of responsible person
Sanaz Tahmourespour
Position
Resident in paediatric dentistry
Other areas of specialty/work
Street address
IslamicAzad University of Khorasgan, University Blvd., Arghavanieh, Eastern Jei Ave.
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
Sanaz_t62@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Khorasgan( Isfahan) Branch
Full name of responsible person
Neda Ahmadi Rozbahani
Position
Assistant professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Islamic Azad University of Khorasgan, University Blvd., Arghavanieh, Eastern Jei Ave.
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
N.rozbahani@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Khorasgan (Isfahan ) Branch
Full name of responsible person
Mitra Hajari
Position
Dentist
Other areas of specialty/work
Street address
Islamic Azad University of Khorasgan, University Blvd., Arghavanieh, Eastern Jei Ave.
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)