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Comparison the effect of massage and topical anesthetic gel on the intensity of pain due to inferior alveolar nerve block injection in 5-7 years old children

Protocol summary

Summary
Purpose: Comparison the effect of massage and topical anesthetic gel on the intensity of pain due to inferior alveolar nerve block injection in 5-7 years old children, Design: Randomized Clinical Trial, Population: Children Referred to Pediatric Department of Zahedan Dental School, Inclusion Criteria: Healthy 5-7 Years Old Children Need Bilateral Inferior Alveolar Nerve Block Injection, Exclusion Criteria: Mental Retardation, Children with Systemic Disease, History of dental treatment, History of sensitivity to anesthetics, Taking medications that affect pain, Sample Size: 2 Groups of 30 ones, Subjects Intervention: Comparison the effect of massage on the intensity of pain due to intraoral injection, Pain Time: 5 Minutes Before Using Block Injection, Outcomes: Reducing the Pain of IntraOral Injection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014111513218N4
Registration date: 2015-03-20, 1393/12/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-03-20, 1393/12/29
Registrant information
Name
Elham Hosseini
Name of organization / entity
Zahedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 937 203 9978
Email address
drelhamhosseini@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Science
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-07-06, 1393/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of massage and topical anesthetic gel on the intensity of pain due to inferior alveolar nerve block injection in 5-7 years old children
Public title
Comparison the effect of massage on the intensity of pain due to anesthetic injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Healthy children; 5-7 years old; children require Bilateral Inferior Alveolar Injection; Cooperative group (Frankel 3-4). Exclusion Criteria: Children with Systemic Disease; Mental Retardation; History of dental treatment; History of sensitivity to anesthetics; Taking medications that affect pain.
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Zahedan University of Medical Science
Street address
Zahedan University of Medical Science, Dr. Hesabi Square
City
Zahedan
Postal code
9816743463
Approval date
2014-06-01, 1393/03/11
Ethics committee reference number
6666

Health conditions studied

1

Description of health condition studied
Comparison the effect of massage and topical anesthetic gel on the intensity of pain due to inferior alveolar nerve block injection in 5-7 years old children
ICD-10 code
R52.0
ICD-10 code description
pain

Primary outcomes

1

Description
Pain of Injection
Timepoint
During injection
Method of measurement
Sum of the points of Sound, Eye and Movement according to SEM parameters. point 3(minimum pain intensity) to 12(maximum pain intensity).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: In the case group, the injection site will be massaged by finger for 1 minute before injection.
Category
Treatment - Other

2

Description
Intervention 2: In the control group, topical anesthetic gel "benzocaine" will be applied at the injection site for 1 minute before injection.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric Department, Zahedan Dental School
Full name of responsible person
Homa Rastegar
Street address
Dental School, East Azadegan street
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Dr. Hooshang Rafighdoost
Street address
Zahedan University of Medical Science, Dr. Hesabi Square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Homa Rastegar
Position
Dental Student
Other areas of specialty/work
Street address
Tehran, Sardar Jangal boulevard
City
Tehran
Postal code
1476955959
Phone
+98 21 4445 5457
Fax
Email
homa.rastegar69@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Dr. Elham Hosseini
Position
Specialist in Pediatric Dentistry
Other areas of specialty/work
Street address
Dental school, East Azadegan street
City
Zahedan
Postal code
Phone
+98 54 1244 1824
Fax
Email
drelhamhosseini@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Homa Rastegar
Position
Dental Student
Other areas of specialty/work
Street address
Tehran, Sardar Jangal boulevard
City
Tehran
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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