Protocol summary
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Study aim
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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
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Design
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A clinical trial with a control group, with parallel groups, without blinding, randomized
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Settings and conduct
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Implementation of the study in the injections section of Vasei Hospital in Sabzevar. The exact location of ventrogluteal and dorsogluteal (DG) sites was determined using V and square method respectively.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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1) in the control group all patients received dorsogluteal injection (traditional way).
2) in the anthropometric group, the algorithm presented by Larkin et al. was used to select the site of gluteal injection based on sex, weight, BMI, waist circumference (WC) and anterior superior iliac spine to iliac tubercle (ASIS-IT)
3) in the body shape pattern group, the algorithm presented by Larkin et al. was used to select the site of gluteal injection based on observed body shape indices (OBS), BMI and gender.
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Main outcome variables
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severity of intramuscular injection pain
General information
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Reason for update
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After an epidemiologist was added to the research team, the study design changed briefly. Therefore, the corrections made to the study were updated
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180826040875N1
Registration date:
2018-09-29, 1397/07/07
Registration timing:
prospective
Last update:
2020-04-10, 1399/01/22
Update count:
1
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Registration date
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2018-09-29, 1397/07/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-10-22, 1397/07/30
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Expected recruitment end date
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2018-12-21, 1397/09/30
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Actual recruitment start date
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2018-10-27, 1397/08/05
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Actual recruitment end date
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2018-12-31, 1397/10/10
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Trial completion date
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2018-12-31, 1397/10/10
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Scientific title
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A comparative study on the effect of intramuscular injection site selection according to anthropometric and demographic body shape assessment methods on pain injection
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Public title
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Does selecting the site of injection based on anthropometric indices and body shape reduces the pain of injection?
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
Patients with psychopathy, diabetes,neuropathy, delirium, dementia, coagulopathy, and those had an extreme fear of injections
Use of opiate or non-opiate analgesics 6 hours before enrollment
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
162
Actual sample size reached:
162
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Enrolled subjects were randomly assigned to a 1:1 ratio using a web-based random allocation system in undisclosed block sizes of six. There were 168 sequentially numbered opaque sealed envelopes (SNOSE) that contained a group assignment for the subjects. The envelopes were shuffled and distributed to each subject. The registered nurse chose the method of injection after opening the undisclosed envelope.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Three group randomized controlled clinical trial study
Ethics committees
1
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Ethics committee
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Approval date
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2018-09-24, 1397/07/02
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Ethics committee reference number
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IR.MEDSAB.REC.1397.037
Health conditions studied
1
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Description of health condition studied
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pain of intramuscular injection
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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severity of pain after intramuscular injection in gluteal muscles
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Timepoint
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After injection
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Method of measurement
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The Visual Analogue Scale (VAS)
Intervention groups
1
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Description
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Intervention group: Selection of injection site using an algorithm extracted from demographic and anthropometric indices
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Category
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Treatment - Other
2
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Description
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Intervention group: Selection injection site with body shape pattern and demographic indicators
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Category
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Treatment - Other
3
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Description
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Control group: Injection in the dorsogluteal position
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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The authors received no financial support for the research, authorship, and/or publication of this article.
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available