A comparative study on the effect of intramuscular injection site selection according to anthropometric and demographic body shape assessment methods on pain injection
Determining thethe effect of intramuscular injection site selection according to anthropometric and demographic body shape assessment methods on pain injection
Comparison of the severity of injection pain in two methods of selecting an injection site based on anthropometric and demographic indicators with body shape, body mass index and sex
Design
Clinical practice with two intervention groups And a community-based, action-oriented control group with Factorial groups , One-sided blind, randomized with permutation blocks
Settings and conduct
Implementation of the study in the injections section of Vasei Hospital in Sabzevar، Available sampling،Allocation of random groups of permutable blocks،Then the Selection site of injection and injection was the standard protocol Then the intensity of the injection pain is measured.
Participants/Inclusion and exclusion criteria
Problems in communicating, cognitive problems, having sensory or motor problems, stiffness and sensitivity or history of injection in the site and history of mental illness, diabetes and Norpathy prevents people from entering the study
Intervention groups
Group 1: Injection site based on anthropometric algorithm Then the intensity of the injection pain is measured.
Group 2: The injection site is selected based on the body shape pattern Then the intensity of the injection pain is measured.
Group 3: Selection of injection site with traditional method Then the intensity of the injection pain is measured.
Main outcome variables
intensity pain intramuscular injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180826040875N1
Registration date:2018-09-29, 1397/07/07
Registration timing:prospective
Last update:2018-09-29, 1397/07/07
Update count:1
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Azam Khosrojerdy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4429 6339
Email address
khosrojerdia95@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of intramuscular injection site selection according to anthropometric and demographic body shape assessment methods on pain injection
Public title
The effect site selection on pain intensity of intramuscular injection
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Participants in the research have written consent
There is no problem communicating (example: hearing, vision, speech, common language)
At least 18 years old and maximum 65 years
Exclusion criteria:
Having very severe pain due to the disease
Having a physical (motor or sensory) problem
Toughness and tenderness and pain at the injection site
Having a former injection site in the last two weeks
History of mental illness, diabetes and light-headedness
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
162
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling method, the method of assigning patients to permutational block using statistical software
Blinding (investigator's opinion)
Single blinded
Blinding description
participants
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Vasei Hospital, Nuclear Martyrs Blvd
City
Khorasan Razavi
Province
Razavi Khorasan
Postal code
9617747431
Approval date
2018-09-24, 1397/07/02
Ethics committee reference number
IR.MEDSAB.REC.1397.037
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
2
Description of health condition studied
intramuscular injection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Timepoint
Method of measurement
2
Description
intensity pain intramuscular injection
Timepoint
During injection and immediately after injection
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Timepoint
Method of measurement
2
Description
Timepoint
Method of measurement
3
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: Selection of injection site using an algorithm extracted from demographic and anthropometric indices
Category
Treatment - Other
2
Description
Intervention group: Selection injection site with body shape pattern and demographic indicators
Category
Treatment - Other
3
Description
Control group: Select the injection site with the traditional method
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei Hospital in Sabzevar
Full name of responsible person
Azam Khosrojerdy
Street address
Nuclear Martyrs Blvd, Vassie Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
khosrojerdiA95@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Gharat
Street address
Vassie Hospital, Nuclear Martyrs Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
khosrojerdiA95@medsab.ac.ir
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
Azam Khosrojerdy
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vassie Hospital, Nuclear Martyrs Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747131
Phone
+98 51 4465 1300
Email
khosrojerdiA95@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Abdul Ghader Assarroudi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1014
Email
khosrojerdiA95@medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Azam Khosrojerdy
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vassie Hospital, Nuclear Martyrs Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
khosrojerdiA95@medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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