The effect of jasmine aromatherapy on patient cooperation and pain and anxiety during dental practice in pediatric dentistry
Design
A randomized clinical trial with 4 patients using random allocation software
Settings and conduct
Aromatherapy is accomplished by a container of water and a candle so that the candle is placed under the container and the jasmine extract is dispersed at room temperature.
After aromatherapy, the anxiety level of all patients in both groups after completion of dental work was assessed
Participants/Inclusion and exclusion criteria
1. Age 6 to 12 years
2. Candidate for dental practice with previous record
3. Child with Frankel + or ++
4. A history of dentistry for a child to perform simple tasks such as fluoride therapy and fissure sealant.
5. Children in need of Class 1 restorative treatment of primary or permanent tooth with infiltration anesthesia,
1. Patients with the first visit to dentistry
2. The systemic and mental illness of the child in such a way as to prevent the necessary co-operation at work
3. Odor disorder or any respiratory illness that may affect the sense of smell
4. A history of allergy sensitivity
5. Affected by allergies and colds
6. Sensitivity to jasmine odor
7. Patients with spontaneous pain
Intervention groups
The demographic information of patients, including age and sex, will be reviewed and recorded first. In the first and second week, the control group received aromatherapy with distilled water, and in the third and fourth weeks, the intervention group received aromatherapy. All patients in both groups receive aromatherapy in a 10-square-meter waiting room. Then all patients in the intervention group received aromatherapy with 2 ml of jasmine extract and control group received aromatherapy with distilled water for 15 minutes.
Main outcome variables
Pain and anxiety control during dental procedures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200218046545N1
Registration date:2020-05-10, 1399/02/21
Registration timing:retrospective
Last update:2020-05-10, 1399/02/21
Update count:0
Registration date
2020-05-10, 1399/02/21
Registrant information
Name
Mehdi Jaafarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3662 0028
Email address
mejsamani@yahoo.co.uk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Jasmine aroma on patient’s anxiety, pain and cooperation in dental Procedures in 7-12 years old children
Public title
The effect of Jasmine aroma on patient’s anxiety
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age 7 to 12 years
Candidate for dental practice with previous record
Child with Frankel + or ++
A history of dentistry for a child to perform simple tasks such as fluoride therapy and fissure sealant
Children in need of Class 1 restorative treatment of primary or permanent tooth with infiltration anesthesia
Exclusion criteria:
Patients with the first referral to dentistry
Systemic and mental illness of the child in such a way as to prevent the necessary cooperation during the work
Odor disorder or any respiratory illness that may affect the sense of smell
A history of anesthesia
Affected by allergies and colds
Sensitivity to jasmine odor
Patients with spontaneous pain
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
a simple accident
Individual accident
Randomization software with statistical software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Medical Sciences Ethics Committee
Street address
hezarjrib aveneu Isfahan University of Medical Sciences
City
isfahan
Province
Isfehan
Postal code
8157895561
Approval date
2020-02-19, 1398/11/30
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.657
Health conditions studied
1
Description of health condition studied
Pain during dental procedures
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Patient anxiety during dental procedures
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
1.modified child dental anxiety scale : This questionnaire has 8 questions, each of which measures the anxiety level on each index with a range of five Elikert options from extreme fear, high fear, moderate fear, low fear, and complete relaxation, which scores from 1 to 5 The order of the minimum and maximum points for each person is 8 and 40 respectively. 2.Visual Analogue Scale: Visual pain rating scales are used to assess the severity of pain during dental procedures, including smileys, and the child identifies the severity of pain with a finger from zero to 10.
Intervention group: 28 children aged 7 to 12 years are in this group and are treated with jasmine flower aromatherapy. For each child in a waiting room of 3 square meters, they underwent aromatherapy once. Then, all patients in the intervention group undergo aromatherapy with 2 ml of jasmine flower extract.
Category
Placebo
2
Description
Control group: 28 children aged 7 to 12 years are in this group. They are controlled by aromatherapy with jasmine flowers. For each child, 1 bar of distilled water in a waiting room of 3 square meters replaces aromatherapy with jasmine flowers.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Dental School
Full name of responsible person
Mehdi Jafarzade
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8157895561
Phone
+98 31 3792 3120
Email
Mejsamani@yahoo.co.uk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Jafarzade
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8157895561
Phone
+98 31 3792 3120
Email
Mejsamani@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faculty of Dentistry, Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Jafarzade
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8157895561
Phone
+98 31 3792 3120
Email
Mejsamani@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Jafarzade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8157895561
Phone
+98 31 3792 3120
Email
Mejsamani@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Jafarzad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8157895561
Phone
+98 31 3792 3120
Email
Mejsamani@yahoo.co.uk
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
No - There is not 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
Only part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any scientific analysis to expand the field under investigation
From where data/document is obtainable
Dr Mehdi Jafarzadeh email mejsamani@yahoo.co.uk
What processes are involved for a request to access data/document
The applicant must be a professional doctoral student or one of the professors or researchers of scientific centers, and after reading the e-mail, it will be delivered to the applicant.