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A comparative study of the effect of educational animation and lavender scent on anxiety, anger and pain in children referred to dentistry

Protocol summary

Study aim
A comparative study of the effect of educational animation and lavender scent on the level of anxiety, anger and pain in children who go to the dentist
Design
A clinical trial with a control group with randomized parallel groups on 132 patients. To randomize, the rand function of Excel software for boys and girls was used separately for random blocks.
Settings and conduct
Children with dental problems in the age range of 4 to 6 years who refer to Tadayon Health Center and the School of Dentistry, if they wish to participate in the study, enter the study with the informed consent of their parents. After measuring anxiety, anger and pain, randomization is performed and the relevant intervention is performed and then the dependent variables are measured before entering the office and after anesthesia injection.
Participants/Inclusion and exclusion criteria
The desire of the patient (parents) to participate in the study Children in the age range of 4 to 6 First visit to dentistry No disturbance in the five senses Do not take sedatives the day before Not having a known case of mental illness Absence of asthma, bronchitis, chronic respiratory diseases
Intervention groups
In the animation group, before the child goes to the dentist room, an animation is shown to the child for 3 minutes by a tablet. In the lavender group, 2 drops of 100% lavender essential oil prepared by Barij Essential Oil Company are poured on a piece of gauze 10 minutes before going to the dentist's room and attached to the patient's collar and removed before going to the room. No action is taken in the control group
Main outcome variables
Child Anxiety Measured using the Anxiety Scale Video Scale Anger, which is measured using the Anger Image Scale Pain, which is measured by the scale of behavioral reactions caused by pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110430006342N13
Registration date: 2022-01-07, 1400/10/17
Registration timing: prospective

Last update: 2022-01-07, 1400/10/17
Update count: 0
Registration date
2022-01-07, 1400/10/17
Registrant information
Name
Ali Asghar Ghods
Name of organization / entity
Semnan Universioty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4192
Email address
aaghods@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of educational animation and lavender scent on anxiety, anger and pain in children referred to dentistry
Public title
The effect of animation and lavender on anxiety, anger and pain in children in dentistry
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All children 4 to 6 years old referring to dentistry
Exclusion criteria:
Second or more visits to the dentist - having a disorder of the five senses - taking sedatives the day before the visit - a known case of mental illness - the presence of asthma, bronchitis and chronic respiratory diseases
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocks by gender using a table of random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research
Street address
Deputy of research and technology, Central Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2021-12-28, 1400/10/07
Ethics committee reference number
IR.SEMUMS.REC.1400.261

Health conditions studied

1

Description of health condition studied
Dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries

Primary outcomes

1

Description
Anxiety score
Timepoint
Before the intervention, immediately after the intervention and after the anesthetic injection
Method of measurement
Wenham Anxiety Scale

2

Description
Anger score
Timepoint
Before the intervention, immediately after the intervention and after the anesthetic injection
Method of measurement
Visual Anger Scale

3

Description
Pain score
Timepoint
Before the intervention, immediately after the intervention and after the anesthetic injection
Method of measurement
behavioral pain assessment scale

Secondary outcomes

1

Description
Pulse rate
Timepoint
Before the intervention, immediately after the intervention and after the anesthetic injection
Method of measurement
Count the pulse number

2

Description
Respiration rate
Timepoint
Before the intervention, immediately after the intervention and after the anesthetic injection
Method of measurement
Count the respiration number

Intervention groups

1

Description
Intervention group:
Category
Prevention

2

Description
Intervention group:
Category
Prevention

3

Description
Control group:
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dentistry faculty
Full name of responsible person
Elham Mirahmadi
Street address
School of Dentistry, 17 Shahrivar Blvd.
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 4700
Email
dent@semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Deputy of research and technology, Central Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3105 2120
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
aaghods@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Associare Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
aaghods@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
aaghods@yahoo.com

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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
After collecting the data, the report will be submitted to the Deputy Minister of Research and Technology
When the data will become available and for how long
one year after data collection
To whom data/document is available
researchers
Under which criteria data/document could be used
Citing the source
From where data/document is obtainable
Responsible researcher
What processes are involved for a request to access data/document
Delivered one month after request
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