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Comparative evaluation of effectiveness of using “external cold and vibration” and “cold” on amount of pain caused by maxillary infiltration in 6-12 year-old children

Protocol summary

Study aim
Considering the importance of pain and stress control in pediatric we decided to improve pain management techniques and increase treatment satisfaction for children
Design
Randomized clinical trial, crossover control, double blind, on 30 patients.
Settings and conduct
The site of this study is doctor mehdi jafarzade clinic. After applying BUZZY, we calculate the amount of pain felt with two scales, Wong-Baker and FLACC. we write down pulse rate before, during and after the injection. To blind the child, we put the device off his face in the control session. We use a pulse oximeter to measure heart rate.
Participants/Inclusion and exclusion criteria
Children 6-12 years old are physically and mentally healthy, have no underlying disease, do not take painkillers or sedatives. Be positive or completely positive about frankl's behavioral classification. Have no previous history of dental treatment and toothache at the time of visit, require deep D or E teeth restoration on both sides of the maxilla. Children with chronic illness, mental problems, behavioral problems, congenital disorders, hearing and speech disorders, if the area to be implanted has pathology or inflammation, non-working children will be excluded from the study.
Intervention groups
The Buzzy places on the skin of the injection site and holds it for two minutes. The dentist then applies 20% benzocaine surface anesthesia gel to the mucosa of the injection site with an applicator and performs the infiltration anesthesia for one minute after 30 seconds. In the control session, only the superficial anesthesia gel is used.
Main outcome variables
Amount of felt pain, heart rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210815052196N1
Registration date: 2021-09-04, 1400/06/13
Registration timing: registered_while_recruiting

Last update: 2021-09-04, 1400/06/13
Update count: 0
Registration date
2021-09-04, 1400/06/13
Registrant information
Name
Fateme Shadmanfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 9123
Email address
fatemeshd@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-25, 1400/06/03
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of effectiveness of using “external cold and vibration” and “cold” on amount of pain caused by maxillary infiltration in 6-12 year-old children
Public title
Effect of cold and external vibration in local anesthesia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Children who are physically and mentally healthy, they have no underlying disease they are not currently taking painkillers or sedatives Children should be positive or completely positive about Frankl's behavioral classification during the dental examination he child should have no history of previous dental treatment and toothache at the time of referral they require deep D or E tooth restorations on both sides of the maxilla they are willing to participate in the study
Exclusion criteria:
Have a history of hospitalization due to dental surgery children with chronic illnesses (such as asthma, allergies, diabetes, sickle cell disease, cystic fibrosis, dermatitis) children with behavioral problems (such as autism, ADHD, learning disabilities) patients with mental health problems, patients Congenital disorders, hearing and speech disorders are also not included in the study The child will be excluded from the study if the area to be implanted has pathology or if there is inflammation at the injection site non-working children will not participate in the study.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
Each child has an intervention session and a control session, each session being performed on one side of the jaw
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is done by sealing the envelope. The randomization unit is individual. There are two envelopes, one with the word buzzy and the other with the word control. We ask the child to choose an envelope at the beginning of the session. The package that will be chosen will be the treatment method in the first session.
Blinding (investigator's opinion)
Double blinded
Blinding description
The analyzer does not know the data related to intervention and control. Also, in the control session for blinding the participant, the device is placed off on the child's face.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St, Esfahan
City
Esfahan
Province
Isfehan
Postal code
7346181746
Approval date
2021-08-22, 1400/05/31
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.220

Health conditions studied

1

Description of health condition studied
A child has deep caries in the maxillary D and E teeth that requires local anesthesia.
ICD-10 code
K02
ICD-10 code description
Dental caries

Primary outcomes

1

Description
Pain index
Timepoint
Measure of pain index immediately after injection
Method of measurement
Wong-baker index, FLACC index

2

Description
Heart rate
Timepoint
5 minutes before injection, during injection, 5 minutes after injection
Method of measurement
Pulse oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The parent places the Buzzy on the skin of the injection site and holds it for two minutes. The dentist applies surface anesthesia gel to the mucusa of the injection site with an ear cleaner, and after 30 seconds of injection, performs the infiltration anesthesia for one minute. The device should be in place during the application of the superficial anesthetic gel and the injection.
Category
Treatment - Devices

2

Description
Control group: only cold and surface anesthesia gel are used. To blind the baby, we put the Buzzy on the baby's face without turning on the vibration and cold wings, and after two minutes, the surface anesthetic gel is applied by the ear cleaner for 30 seconds and the injection is done.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Doctor mehdi jafarzade clinic
Full name of responsible person
Doctor mehdi jafarzade
Street address
Third floor, Sepehr Building, corner of Hezar Jerib, Darvase Shiraz, Esfahan.
City
Esfahan
Province
Isfehan
Postal code
8168953381
Phone
+98 31 3669 8825
Email
Mejsamani@yahoo.co.uk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh haghjoy javanmard
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St, Esfahan.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Dr Reyhane Faghihian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
9th floor, Block 4, Doctors Building, Aref St., Third Moshtaq, Esfahan.
City
Esfahan
Province
Isfehan
Postal code
8158184959
Phone
+98 31 3263 8163
Email
Reyhane.fgh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Reyhane Faghihian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
9th floor, Block 4, Doctors Building, Aref St., Third Moshtaq, Esfahan.
City
Esfahan
Province
Isfehan
Postal code
8158184959
Phone
+98 31 3263 8163
Email
Reyhane.fgh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Reyhane Faghihian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
9th floor, Block 4, Doctors Building, Aref St., Third Moshtaq, Esfahan.
City
Esfahan
Province
Isfehan
Postal code
8158184959
Phone
+98 31 3263 8163
Email
reyhane.fgh@gmail.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
Age and gender, Frankel classification, fear score, children's heart rate after non-identification
When the data will become available and for how long
Access starts one month after publication
To whom data/document is available
General dentists and pediatric dentists , researchers working in academic institutions can apply for it.
Under which criteria data/document could be used
The use of data for systematic review and meta analysis will be allowed.
From where data/document is obtainable
Dr. Reyhane Faghihian reyhane.fgh@gmail.com Fateme shadmanfar. fatemeshd@yahoo.com
What processes are involved for a request to access data/document
The applicant must submit their application via email. The email must state the reason for the request and the use of it. Data will be sent up to one month after the request is submitted.
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