Given that little research has been done on examining the relationship between a person's actual pain threshold and what it expresses by the severity of the pain, we found it useful to find the similarity or difference of pain expressed by anesthetic injection and pain threshold and to determine whether the pain reported from The patient is affected by factors such as anxiety, fear of needle and injection, and then compare it with the actual threshold of pain via compression pain threshold (other than the needle and injection process).
Design
Clinical trial, easy sampling, two groups with more and less pain threshold
Settings and conduct
At each visit, the threshold of compressive pain is measured using an algometer method (other than dental) and then the severity of pain due to infiltration of the maxillary infiltration (in the dental setting) is recorded by the VAS method. Of all subjects, 50% of those with higher pain thresholds (group B) compared with 50% of those with lower pain thresholds (group A) compared the severity of sensations associated with injections of maxillary infiltration, and the results were compared. The following is reported.
Participants/Inclusion and exclusion criteria
General health, lidocaine insensitivity, non-sedation and antidepressant medication for two weeks, no myofascial pain and cervical cramps, no dental pain during the past month
Intervention groups
Of those who met the criteria, 200 were selected by easy sampling.At first, pain thresholds are measured by algometric method and then divided into two groups with higher and lower pain thresholds.The two groups underwent topical anesthesia and the patient's reported pain was compared with the pain threshold.
Main outcome variables
Pain threshold, pain during injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190803044415N1
Registration date:2019-08-05, 1398/05/14
Registration timing:prospective
Last update:2019-08-05, 1398/05/14
Update count:0
Registration date
2019-08-05, 1398/05/14
Registrant information
Name
amirhossein azimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8847 2511
Email address
dr.amirh1996.azimi96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of relation between pressure pain threshold and pain severity of anterior maxillary infiltration injection
Public title
Evaluation of relation between pressure pain threshold and pain severity of anterior maxillary infiltration injection
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
general health
Not allergic to lidocaine
Lack of toothache over the past month
Exclusion criteria:
Use of sedatives and antidepressants over the past two weeks
Myofascial pain and neck cramps
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kermanshah University of Medical Sciences
Street address
padis, Amiriyeh Towers, Block lale 2, Floor 8, Unit 8
City
kermanshah
Province
Kermanshah
Postal code
6718815785
Approval date
2019-06-24, 1398/04/03
Ethics committee reference number
ir.kums.rec.1398.265
Health conditions studied
1
Description of health condition studied
The Relationship between Pressure Pain Threshold and Pain from Anesthesia Injection
ICD-10 code
F43.8
ICD-10 code description
Other reactions to severe stress
Primary outcomes
1
Description
pressure pain threshold
Timepoint
At the beginning of the intervention
Method of measurement
Taiwanese Lutron power meter with a measuring accuracy of 0.01 kg
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After recalling patients to the Restoration section, volunteers fill out a Beck Anxiety Inventory to determine the level of anxiety. Of those who met the criteria, 200 were selected by easy sampling. At each visit, the threshold of compressive pain is measured using an algebraic method (other than dental) and then the severity of pain due to infiltration of the maxilla (in the dental setting) is recorded by the VAS method. Of all subjects, 50% of those with higher pain thresholds (group B) compared with 50% of those with lower pain thresholds (group A) compared the severity of sensations associated with injections of maxillary infiltration, and the results were compared. The following is reported.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah Dental School
Full name of responsible person
Amirhossein Azimi
Street address
Shariati
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
dr.amirh1996.azimi96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Mohamad Moslem Imani
Street address
Shriati,Kermanshah town
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
dr.amirh1996.azimi96@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
70
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Roohallh Sharifi Lorestani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dr. Shariati Street,Above Shura Street, in front of the Post Office
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
dr.amirh1996.azimi96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
DrRohallah Sharifi Lorestani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shariati
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
37227151
Email
R.sharifi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amirhossein Azimi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Pardis,Amirie tower
City
Kermanshah
Province
Kermanshah
Postal code
6718815785
Phone
0098337287517
Email
dr.amirh1996.azimi96@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
No - There is not a plan to make this available
Title and more details about the data/document
Registered forms are provided
When the data will become available and for how long
12 months after printing the results
To whom data/document is available
Kermanshah Dental School Professors
Under which criteria data/document could be used
Possibility of re-investigation
From where data/document is obtainable
Dr Rohallah Sharifi
What processes are involved for a request to access data/document
Initially, the request will be sent by email, then the documents will be presented in person.