To evaluate the effect of orange odor on reduction of children anxiety during dental treatment in a randomized study. Among 6 to 9 years old children who need to fissuresealant therapy of at least 2 first permanent molars, 30 cases are selected. Our selection and division in two groups is randomized. This study will be performed in two dental visits for each case. In each visit, first prophylaxy and then fissuresealant therapy will be performed with conventional behavior management (tell, show, do). 15 children will be exposed to orange odor in first visit and will be treated in the second one conventionally. Another15 children will be exposed to orange odor in second visit and will be treated in the first cession conventionally. We use natural essential oil of orange in a diffuser for case group and water for control group. We assess salivary cortisol and heart rate for anxiety evaluation two times (before and after treatment) in each visit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201258821N1
Registration date:2012-03-01, 1390/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-01, 1390/12/11
Registrant information
Name
Fateme Farahbakhsh pour
Name of organization / entity
Dental faculty, Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1626 8215
Email address
fatemefarahbakhsh@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of dental faculty of Isfahan university of medical sciences
Expected recruitment start date
2012-02-29, 1390/12/10
Expected recruitment end date
2012-04-29, 1391/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aromatherapy with orange essential oil on children anxiety during dental treatment
Public title
Effect of aromatherapy on children anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 6 to 9 years old; need to fissuresealant therapy of at least 2 first permanent molars; absence of dental caries in related teeth; absence of systemic problems and mental and physical disability; absence of defect in olfactory and respiratory system; frankle + in frankle cooperation criteria. Exclusion criteria: history of dental treatment; catch cold; asthma and allergy.
Age
From 6 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Reasearch center of faculty of dentistry of Isfahan university of medical sciences
Street address
Dental faculty of Isfahan medical sciences, Hezar Jerib avenue
City
Isfahan
Postal code
81846-73461
Approval date
2011-05-28, 1390/03/07
Ethics committee reference number
390146
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
anxiety
Timepoint
two times in each visit,before and after intervention
Method of measurement
salivary cortisol and heart rate
Secondary outcomes
1
Description
salivary cortisol
Timepoint
two times in each visit,before and after intervention
Method of measurement
saliva sampling
2
Description
heart rate
Timepoint
two times in each visit,before and after intervention