Comparison of the Effects of Lidocaine Sprays and Ecupressure on Muscle Pain Injection
Design
A clinical trial with a control group with parallel group design of 252 patients, one blind, randomized control group
Settings and conduct
This study is randomized clinical trial. The research population is the patients who visit the emergency department of Neyshabour 22 Bahman Hospital for intramuscular injection. A demographic questionnaire and a VAS visual analogue instrument will be used to collect the data. The instrument complement will not be aware of the type of injection. Before injection, the method of determining the amount of pain will be taught to the patients and oral consent will be obtained from the patients. Patients in Groups A, B, and C are divided into the following simple random sampling, with the following characteristics: Group A: Intramuscular injection without any intervention Group B: Use of lidocaine sprays before muscle injection Group C: Performing intramuscular injection and performing medicine Pressure in the area (UB 31).
Participants/Inclusion and exclusion criteria
At least 15 years old؛ The desire to participate in the study
Intervention groups
Group A: Muscle infusion without any intervention
Group B: Use of lidocaine spray before intramuscular injection
Group C: Perform acupressure before muscle injection
Main outcome variables
Reducing pain in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180110038300N1
Registration date:2019-05-25, 1398/03/04
Registration timing:prospective
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Arezoo Davarinia Motlagh Quchan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4429 0161
Email address
a.davarinia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2020-03-01, 1398/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Lidocaine Sprays and Ecupressure on Muscle Pain Injection
Public title
Comparison of the Effects of Lidocaine Sprays and Ecupressure on Muscle Pain Injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 15 years
The desire to participate in the study
Exclusion criteria:
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
252
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into 3 groups A, B and C by permutation blocks.
Group A intramuscular injection without any intervention
Group B: Use of lidocaine spray before muscle injection
Group C: Acupressure before intramuscular injection
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants were blinded and do not know which of the 3 study groups would be.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Province
South Khorasan
Postal code
9617913114- 96179131
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.MEDSAB.REC.1397.115
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Lidocaine spray
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduse pain of intramuscular injection
Timepoint
Immediately after intramuscular injection
Method of measurement
Visual Analuge Score
Secondary outcomes
1
Description
Determine of Satisfaction
Timepoint
After muscle injections
Method of measurement
check list
Intervention groups
1
Description
Acupressure
Category
Treatment - Other
2
Description
Lidocaine Spray
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Neyshabour Hospital
Full name of responsible person
Arezoo DavariniaMotlagh Quchan
Street address
hekmat
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114- 96179131
Phone
+98 51 4441 7594
Email
a.davarinia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Arezoo Davarinia Motlagh Quchan
Street address
Hekmat
City
sabzevar
Province
Razavi Khorasan
Postal code
: 9617913114- 961791
Phone
+98 51 4441 8356
Email
a.davarinia@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Arezoo Davarinia Motlagh Quchan
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hekmat
City
Sabzevar
Province
Razavi Khorasan
Postal code
: 9617913114- 961791
Phone
+98 51 4441 8356
Email
a.davarinia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Arezoo Davarinia Motlagh Quchan
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hekmat
City
Sabzevar
Province
Razavi Khorasan
Postal code
: 9617913114- 961791
Phone
+98 51 4441 8356
Email
a.davarinia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
َArazoo Davarinia Motlagh Quchan
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 7, Hekmat Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
: 9617913114- 961791
Phone
+98 51 4441 8356
Email
a.davarinai@yahoo.com
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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
No - There is not 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
All information obtained will be unidentified.
When the data will become available and for how long
After printing the results
To whom data/document is available
Researchers working in medical science universities
Under which criteria data/document could be used
There is no other condition.
From where data/document is obtainable
Student research Comitee
What processes are involved for a request to access data/document