Evaluation of the effect of aromatherapy with lavender essential oil on dental anxiety by measuring pulse rate and salivary cortisol during dental treatment in pediatric patients
This randomized controlled clinical trial is performed to evaluate the effect of aromatherapy with lavender essential oil on salivary cortisol and pulse rate as indicators for child's anxiety during dental treatment.
Design
cross over clinical trial using block randomization, including 24 patients, double blinded
Settings and conduct
This study is performed in the Pediatric Dental Clinic of Shiraz University of Medical Science. 24 children are selected and divided in to two groups due to block randomization. One group in the first visit and an other one in the second visit, recieve the composite filling restorative treatment in the room with lavender aroma diffused in the air.For each group the same treatment is done without aroma in the other visit.Pulse rate and visual analog scale(VAS) are recorded and saliva samples(for cortisol level analyzing) are collected during each session, to evaluate the child's anxiety.The children and the nurse who record pulse rate and VAS and collect saliva samples are not aware of the study aim and probable effect of the aroma.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Healthy children with 7-9 years of age, who exhibit Frank’s behavior rating grade III or IV and have decayed lower second primary molars bilaterally which need class I restorative treatment.
Exclusion Criteria: Patients who have any history of dental pain, previous dental visit, history of allergy, children with common cold and children who currently use any medication.
Intervention groups
12 children receive cl 1 composite filling while lavender aroma is diffused in the air during the first visit, and receive the treatment without aroma during the second visit.Other 12 children receive the restorative treatment without aroma in the first and with aroma in the second visit.
Main outcome variables
salivary cortisol level, pulse rate and visual analog scale (VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190119042406N1
Registration date:2019-02-11, 1397/11/22
Registration timing:registered_while_recruiting
Last update:2019-02-11, 1397/11/22
Update count:0
Registration date
2019-02-11, 1397/11/22
Registrant information
Name
Neda Solhjou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3632 8096
Email address
solhjoo_neda@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of aromatherapy with lavender essential oil on dental anxiety by measuring pulse rate and salivary cortisol during dental treatment in pediatric patients
Public title
Evaluation of the effect of aromatherapy on dental anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy children with 7-9 years of age
Patients who exhibit Frank’s behavior rating grade III or IV
Children who have decayed lower second primary molars bilaterally which need class I restorative treatment
Exclusion criteria:
Patients who have any previous dental visit
Children with common cold
Children with history of allergy
Children who currently use any medication
Patients with any history of dental pain
Age
From 7 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
4
we collect 2 saliva samples from each patient in each visit. Overall 4 saliva samples will be collected from esch patient.
Randomization (investigator's opinion)
Randomized
Randomization description
Block permutation design was used to randomized patients to case and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
pediatric patients and the person who evaluates the consequences and the analyzer wont be aware of the goal of the aromatherapy.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Blvd, Shiraz university of medical sciences.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.SUMS.REC.1397.839
Health conditions studied
1
Description of health condition studied
Dental anxiety in pediatric patients
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Salivary cortisol level
Timepoint
Saliva samples are collected before and after dental treatment.
Method of measurement
The level of cortisol in saliva samples are detected using commercial ELISA cortisol kit.
Secondary outcomes
1
Description
Pulse rate
Timepoint
Before the treatment, during the treatment after drilling, at the end of the treatment
Method of measurement
Finger type pulse oximeter
2
Description
Patient’s anxiety in a subjective way
Timepoint
After injection of local anesthesia
Method of measurement
visual analog scale
Intervention groups
1
Description
Intervention group: Each patient receive restorative treatment under aromatherapy with lavender essential oil in the intervention session. 2 drops of pure lavender essential oil from Tisserand company is poured in 100 ml water in Zyklusmed humidifier and diffused in the air 30 minutes before patient's arrival.
Category
Treatment - Other
2
Description
Control group: Each patient receive restorative treatment without aromatherapy with lavender essential oil in the control session. Only water is poured in Zyklusmed humidifier and water steam diffuse in the air 30 minutes before patient's arrival.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
ِِDental clinic of Shiraz university of medical sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Qomabad Ave, Ghasredasht Blvd, Shiraz dental school
City
Shiraz
Province
Fars
Postal code
713451836
Phone
+98 71 3626 3194
Email
dental@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
DR.Yoones Ghasemi
Street address
Zand Blvd, Central building of Shiraz university of medical sciences
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Neda Solhjou
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Qom Abad Ave, Ghasredasht Blvd, Shiraz dental school
City
Shiraz
Province
Fars
Postal code
713451836
Phone
+98 71 3626 3194
Email
Solhjoo_Neda@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Faezeh Ghaderi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz dental school, Ghasrdasht St
City
Shiraz
Province
Fars
Postal code
713451836
Phone
+98 71 3632 8096
Fax
Email
ghaderi_fa@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Neda Solhjou
Position
Pediatric dentistry resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shiraz dental school, Ghasrdasht St
City
Shiraz
Province
Fars
Postal code
713451836
Phone
+98 71 3632 8096
Fax
Email
solhjoo_neda@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
After making the participants unknown, all data are accessible .
When the data will become available and for how long
Data will be accessible 6 months after publishing the results.
To whom data/document is available
University researchers
Under which criteria data/document could be used
Data will be accessible to the studies in which these data are needed such as mete analysis.
From where data/document is obtainable
Ghaderi_fa@sums.ac.ir
solhjoo_neda@yahoo.com
What processes are involved for a request to access data/document
Applicants for data should present the researchers the university authorization.