Determination of the Effect of Acupressure on Anxiety and Pain of Local Anesthesia Injection in 5-7 Years Children
Design
2 randomized selected groups with 30 person that evaluated in the form of parallel and blinded.
Settings and conduct
This research is a blinded clinical trial that performed in children aged 5-7 years old who need to dental treatments.Children are divided into two groups of thirty and level of anxiety and pain are measured before and after acupressure.Participants and dentist and analyst will be blinded.
Participants/Inclusion and exclusion criteria
the children in the age of 5-7 years old that have two carious primary molars in mandible or maxilla that required treatment with local anesthesia
there were any wound or scars in acupressure points
history of systemic disease
mental retardation
history of unfavorable dentistry experiment or hospitalization
history of severe dental pain & acute dental infection
Lack of cooperation
Intervention groups
Intervention group: Children who receive acupressure at the main point
Control group: Children who receive acupressure at the placebo point.
Main outcome variables
anxiety and pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171020036896N6
Registration date:2018-05-30, 1397/03/09
Registration timing:registered_while_recruiting
Last update:2018-05-30, 1397/03/09
Update count:0
Registration date
2018-05-30, 1397/03/09
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32119023
Email address
sajadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupressure on Anxiety and Pain of Local Anesthesia Injection in 5-7 Years Children
Public title
The Effect of Acupressure on Anxiety and Pain of Local Anesthesia Injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
the children in the age of 5-7 years old that have two carious primary molars in mandible or maxilla that required treatment with local anesthesia
there were any wound or scars in acupressure points
Exclusion criteria:
history of systemic disease
mental retardation
history of unfavorable dentistry experiment or hospitalization
history of severe dental pain & acute dental infection
Lack of cooperation
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
In each participant, two interventions take place within two weeks, once acupressure at the main point and once at the point of the placebo, and its effect is measured on anxiety and pain
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization or unrestricted method will be used and randomization unit is Individual .we will use from Flip the coin from the methods of simple randomization because there are 2 groups in this study that actually the tool of randomization is coin. As one of the study groups, I consider the heads and the other group as tails, and according to the size of the sample(60 person), the coin is toss-up. So the subjects are divided into two groups (anxiety and pain groups). The next step Allocation concealment will be done, In such a way that the allocated group is not known before the assignment of the individual. To achieve this goal, a non-transparent, sealed, random sequence envelope is used . In this way, the statistical specialist will provide 60 envelopes and each of the randomly generated links will be recorded on a card and the cards are arranged in the envelopes . In order to maintain a random sequence, the numbering of envelopes on the outer surface is done in the same order. Finally, the envelops are enclosed and placed in the box, respectively. At the time of the implementation of the study, according to the order of entry of eligible participants, one of the envelopes is opened respectively and will determine the group assigned to that participant. In this study, the assistant of Pediatric Dentistry examines the participants in terms of inclusion and exclusion criteria. Randomization methods are done by a statistical specialist and performance of the study is done by a trained assistant of Pediatric Dentistry.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants do not know the type of intervention (the main point of acupressure)
A researcher who performs local anesthesia is not aware of the type of intervention
The data analyzer is also unaware of the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethic Committee of Kerman University of Medical Sciencess
Street address
Vice-Chancellor for Research, Kerman University of Medical Sciences, Tahmasbabad cross, Jahad Street,Kerman
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.KMU.REC.1397.067
Health conditions studied
1
Description of health condition studied
anxiety and pain
ICD-10 code
V
ICD-10 code description
Mental and behavioural disorders
Primary outcomes
1
Description
the level of anxiety
Timepoint
before and after performance of acupressure
Method of measurement
visual analogue scale
2
Description
the level of pain
Timepoint
before and after performance of acupressure
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The application of acupressure in the main point of reduction anxiety
Category
Rehabilitation
2
Description
Intervention group 2: The application of acupressure in the main point of reduction pain
Category
Rehabilitation
3
Description
Control group 1: The application of acupressure in the placebo point of reduction anxiety
Category
Rehabilitation
4
Description
Control group 2: The application of acupressure in the placebo point of reduction pain
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Department of Dental School of Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Sajadi
Street address
Pediatric Department, School of Dentistry,Shafa Street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
Sajadi@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhti
Street address
No.1 Ave,Tahmasebabad Intersection, Research - Vice Chancellor of Kerman University of Medical Science
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
kmu_research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
60
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
Kerman University of Medical Sciences
Full name of responsible person
Dr Hamidreza Poureslami
Position
Professor of Pediatric Department, Faculty of Dentistry ,
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric Department, School of Dentistry, Shafa Street, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+34 32119021
Email
poureslami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Sajadi
Position
Associate Professor of Pediatric Dentistry
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric Department, School of Dentistry, Shafa Street, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+34 32119021
Email
sajadi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Sajadi
Position
Associate Professor of Pediatric Dentistry
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric Department, School of Dentistry, Shafa Street, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+34 32119021
Email
sajadi@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because the study data do not have any other application.
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