2-عنوان به لاتين Effectiveness of Vanilla aromatherapy and Orange aromatherapy on Pain and Anxiety in Children under Dental Procedures
Design
A clinical trial with two intervention groups and a control group with parallel, double-blind, randomized groups was designed to determine the effect of vanilla aroma therapy and orange reed aroma on dental pain and anxiety.
Settings and conduct
This study will be conducted in a dental clinic affiliated to the Kurdistan University of Medical Sciences in a double-blind manner, the participants and also the person who will analyze the data will be blinded.
Participants/Inclusion and exclusion criteria
Consent of children and their parents to participate in the study Children aged 8 to 12 who need treatment for at least one decayed tooth No vision or hearing impairment. Not having fever, illness and mental disorders. Children should not undergo dental surgery. Children should not be under psychiatric or psychological treatment. The first visit of the child
Intervention groups
intervention groups including orange and vanilla aromatherapy
Main outcome variables
Dental pain and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190703044082N6
Registration date:2023-03-10, 1401/12/19
Registration timing:registered_while_recruiting
Last update:2023-03-10, 1401/12/19
Update count:0
Registration date
2023-03-10, 1401/12/19
Registrant information
Name
Fateme Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 4567 8904
Email address
f-mohammadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Vanilla aromatherapy and Orange aromatherapy on Pain and Anxiety in Children under Dental Procedures
Public title
The effect of parsnip and vanilla scent on dental pain and anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Children and their parents should be satisfied to participate in the study
8-12 year old children who need at least one decayed tooth treatment based on doctor's diagnosis.
Not having vision or hearing defects
Not having fever or illness
Not having physical or mental disorders.
Children should not undergo dental surgery
Children should not be under psychiatric or psychological treatment
The child's first visit to the dentist
Exclusion criteria:
1) Reluctance of parents and children to continue studying.
2) Being unpleasant or sensitive to the smell of orange or vanilla for the child.
Age
From 8 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the participants to aromatherapy groups with orange essential oil, aromatherapy with vanilla essence and control, the names of the three groups will be written on paper and taken randomly, and the order of sampling of the groups will be determined. 20 blocks of 6 will be used for random allocation of samples in three groups. In this way, the letter A will be considered for the orange group, the letter B for the vanilla group, and the letter C for the control group. on pieces of paper, and we will pick them randomly. Then, according to the possible order of sampling, it will start.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are blinded to the allocation of which group they will be placed in. That is, children and their families are unaware of whether they have been placed in the orange or vanilla aromatherapy group or the control group. In addition, the person who analyzes the data is blinded to the assignment of individuals to groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences (Research Ethics Committee)
Street address
Hamedan, Shariati Crossroads, Ayatollah Kashani Boulevard, Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838698
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.UMSHA.REC.1401.909
Health conditions studied
1
Description of health condition studied
Tooth Decay
ICD-10 code
K02.9
ICD-10 code description
Dental caries, unspecified
Primary outcomes
1
Description
anxiety
Timepoint
Before and immediately after the procedure
Method of measurement
Modified Child Dental Anxiety Scale by Wang et al
2
Description
pain
Timepoint
Before and immediately after the procedure
Method of measurement
Wong and Baker pain rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In group A (orange aroma therapy), 10 minutes before any intervention by the dentist, the researcher pours 80 cc of distilled water and 8 drops of orange essential oil into the nebulizer. After 10 minutes, the children are subjected to dental procedures, and during the dental procedures, which averaged 30 minutes, orange aroma therapy (8 drops every two minutes) continues.
Category
Treatment - Other
2
Description
Intervention group: Intervention method: In group B (vanilla aroma therapy), 10 minutes before any intervention by the dentist, the researcher pours 80 cc of distilled water and 8 drops of vanilla essential oil into the nebulizer and adds 8 drops of vanilla essential oil every two minutes to intensify Do not reduce the scent. After 10 minutes, children are subjected to dental procedures. During the dental procedures, which averaged 30 minutes, vanilla aroma therapy (8 drops every two minutes) continues.
Category
Treatment - Other
3
Description
Control group: In group C, the researcher pours 80 cc of distilled water and 8 drops of placebo (distilled water) into the nebulizer and adds 8 drops of placebo to it every two minutes so that the severity of the pain does not decrease. After 10 minutes, children are subjected to dental procedures. Aromatherapy with placebo (8 drops every two minutes) continues during dental procedures, which averaged 30 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental clinic affiliated with Kurdistan University of Medical Sciences
Full name of responsible person
Marzieh Hemmatzadeh
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Service
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
ّFateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
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