The effect of watching cartoons and Aromatherapy with orange on pain and anxiety in children under dental procedures in the dental clinic affiliated kurdistan univercity of medical science 2022
Determining the effect of playing cartoons and orange aroma therapy on pain and anxiety of children undergoing dental procedures in the dental clinic affiliated to Kurdistan University of Medical Sciences.1401
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, on 126 children with dental caries, block randomization
Settings and conduct
This study will be conducted in the dental clinic affiliated to the Kurdistan University of Medical Sciences. This clinic has 3 separate rooms, in one room there is a television, in the other room there is a nebulizer, and in the other room there is the main dental equipment.
In the cartoon group, a cartoon is selected and placed on the unit. The researcher will play the cartoon on TV 10 minutes before the procedure, and the cartoon will continue to be played during the procedure.
In the aroma group, 10 minutes before the intervention by the research dentist, a drop of orange essential oil was poured into the nebulizer. After 10 minutes, the children will undergo the procedure. During the procedure, the orange aroma therapy will continue.
In the control group, they receive routine care
Participants/Inclusion and exclusion criteria
Entry: Children aged 8 to 12 years who need treatment for a decayed tooth
Not having vision or hearing defects or fever and illness.
Children should not undergo dental surgery.
Failure to enter: lack of desire to continue studying by parents and children.
The child's lack of attention to the cartoon for more than five minutes.
Intervention groups
In the intervention groups, during 1 session of playing a cartoon or orange aroma therapy, each of which lasts 10 minutes before the start of work and 30 to 40 minutes during the procedure. and the control group for whom routine dental procedures are performed
Main outcome variables
Pain and dental anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190703044082N8
Registration date:2023-03-26, 1402/01/06
Registration timing:registered_while_recruiting
Last update:2023-03-26, 1402/01/06
Update count:0
Registration date
2023-03-26, 1402/01/06
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
2023-03-05, 1401/12/14
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
2023-02-20, 1401/12/01
Actual recruitment end date
2023-08-23, 1402/06/01
Trial completion date
2023-09-23, 1402/07/01
Scientific title
The effect of watching cartoons and Aromatherapy with orange on pain and anxiety in children under dental procedures in the dental clinic affiliated kurdistan univercity of medical science 2022
Public title
The effect of watching cartoons and Aromatherapy with orange on pain and anxiety in children under dental procedures
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children and their parents should be satisfied with their participation in the study
Children 8-12 years old who need at least one decayed tooth to be treated based on the doctor's diagnosis
No vision or hearing impairment
No fever or illness
Not having physical or mental disorders
Children should not undergo dental surgery
The child's first visit to the dentist
Exclusion criteria:
Parents' and children's unwillingness to continue studying.
Smell of orange is unpleasant for the child
Child not paying attention to the cartoon for more than five minutes.
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were divided into two intervention groups and one control group by random block sampling method (20 blocks of 6).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Hamadan University of Medical Sciences
Street address
Hamedan University of Medical sciences, Hamadan Town, Khajeh Rashid Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2023-01-28, 1401/11/08
Ethics committee reference number
IR.UMSHA.REC.1401.939
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: In group A (cartoon therapy), children chose a cartoon and 10 minutes before the procedure and during the procedure, the cartoon continues to play.
Category
Treatment - Other
2
Description
Intervention group: 10 minutes before the intervention, the researcher pours 80 cc of distilled water and 8 drops of orange essential oil into the nebulizer and adds 8 drops of orange essential oil to it every two minutes and continues throughout the procedure, which is 30 to 40 minutes.
Category
Treatment - Other
3
Description
Control group: The control group of children received routine care
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
Erice Gross Building، Taleghani Street, Kurdistan
City
Kurdistan
Province
Kurdistan
Postal code
6651764878
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh mohammadi
Street address
Hamedan University of Medical sciences, Hamadan Town, Khajeh Rashid Blvd
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
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
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
Hamedan University of Medical sciences, Hamadan Town, Khajeh Rashid Blvd
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
Hamedan University of Medical sciences, Hamadan Town, Khajeh Rashid Blvd
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
Hamedan University of Medical sciences, Hamadan Town, Khajeh Rashid Blvd
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