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The effect of acupressure at the LI4 point on injection pain of local anesthesia in children

Protocol summary

Study aim
Determining the effect of acupressure at the LI4 point on injection pain of local anesthesia in children
Design
Sham controlled clinical trial, cross over, double-blinded, coin flip randomization, on 23 samples.
Settings and conduct
During the study, children who refer to the pediatric department of the School of Dentistry of Tehran University of Medical Sciences for treatment will be included in the study if they are eligible. It will be randomly determined with the use of a coin that the first session is acupressure or sham. This study will be double-blind so that the children and their parents and the person recording the pain intensity will not know about the type of intervention.
Participants/Inclusion and exclusion criteria
The samples are among children aged 6-12 years who have grade 1 or 2 according to the criteria of the American Society of Anesthesiology, have a score of 3 (positive) or 4 (completely positive) according to Frankel's behavioral criteria, and need a nerve block or supra periosteal injection(and the type of injection in two sessions is the same). If there is a restriction such as a wound or a bruise at the desired acupoint or there is a local or systemic infection, it will not be included in the study.
Intervention groups
Each participant is treated with the same anesthesia injection technique in at least two sessions, and the studied interventions are performed before the injection. In the intervention session, finger pressure is applied to the LI4 acupoint, and in the control session (placebo) as a sham, the LI4 point is only touched.
Main outcome variables
The pain of local anesthesia injection using face, legs, activity, cry, consolability scale and Faces Pain Scale-Revised

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230502058053N1
Registration date: 2023-06-27, 1402/04/06
Registration timing: prospective

Last update: 2023-06-27, 1402/04/06
Update count: 0
Registration date
2023-06-27, 1402/04/06
Registrant information
Name
Hanieh Moghimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2250 6338
Email address
h-moghimi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure at the LI4 point on injection pain of local anesthesia in children
Public title
Effect of acupressure on injection pain of local anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with an American Society of Anesthesiologists physical status of I or II Children with a Frankl behavior scale of 3 (positive) or 4 (definitely positive) Not receiving analgesics or sedatives at least 12 hours before the procedure Needing nerve block or supra periosteal injection (same injection technique for 2 sessions)
Exclusion criteria:
Be familiar with acupressure techniques Limitation on the acupoint like ulcers or bruise Needing for needle re-entry during injection Local or systemic infection
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 23
More than 1 sample in each individual
Number of samples in each individual: 2
In each patient, pain during injection for two teeth that are similar in terms of injection technique will be recorded in two different sessions, each based on acupressure intervention or sham (as a placebo control).
Randomization (investigator's opinion)
Randomized
Randomization description
With a coin flip randomization, each participant allocates to intervention or control (placebo) in the first session.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome evaluators are not familiar with acupressure techniques. And all the steps in the control (placebo) and intervention sessions are as same as each other, but in the control (placebo) session, LI4 acupoint will be touched.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of school of dentistry of Tehran University of Medical Sciences
Street address
School of dentistry of Tehran University of Medical Sciences, next to Atomic Energy Organization, North Karegar St.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Approval date
2023-05-22, 1402/03/01
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1402.016

Health conditions studied

1

Description of health condition studied
The pain of local anesthesia injection
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain of dental injection
Timepoint
During injection and 5 minutes after injection
Method of measurement
1)face, legs, activity, cry, consolability scale 2) faces pain scale-revised

Secondary outcomes

empty

Intervention groups

1

Description
With the flip of a coin, it is determined that each participant will receive the acupressure intervention or the control in the first session. So, if the acupressure intervention is performed in the first session, the control intervention will be performed in the second session and vice versa. Intervention session: Acupressure is performed by only one trained person. The acupoint LI4 (He Gu) is identified on the back surface of the hand and halfway between the first and second metacarpal bones (a little closer to the second metacarpal). Acupoint stimulation is done by pressing the thumb for 2 seconds and ten times. Then pressure is continuously applied for 10 seconds. And finally, the pressure is applied again for 2 seconds and ten times. The same procedure is repeated for the opposite hand. After that, the required dental injection is performed. Injection with 2% lidocaine; epinephrine 1.80000 is done in the maximum amount of 1.8 cc and one person does all the injections.
Category
Treatment - Other

2

Description
Control session (placebo): In this session as a sham, all the process mentioned in the previous section will be done, with the difference that the LI4 point is only touched by considering the mentioned times.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of dentistry, Tehran University of Medical Sciences
Full name of responsible person
Mahdie sadat Moosavi
Street address
School of dentistry of Tehran University of Medical Sciences, next to Atomic Energy Organization, North Karegar St
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4025
Email
dentistry@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Research and Technology Vice-Chancellor, 6th floor, Central Organization of the Tehran University of Medical Sciences, corner of Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hanieh Moghimi
Position
postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of dentistry of Tehran University of Medical Sciences, next to Atomic Energy Organization, North Karegar St
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4025
Email
h-moghimi@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanieh Moghimi
Position
postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of dentistry of Tehran University of Medical Sciences, next to Atomic Energy Organization, North Karegar St
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4025
Email
h-moghimi@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanieh Moghimi
Position
postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of dentistry of Tehran University of Medical Sciences, next to Atomic Energy Organization, North Karegar St
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4025
Email
h-moghimi@razi.tums.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
Patients confidentiality
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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