Comparison of the Efficacy of Shotblocker and Acupressure in Reducing Pain Due to Intramuscular Injection

July 10, 2022 updated by: Tülay KILINÇ, Ataturk University

Comparison of the Efficacy of Shotblocker and Acupressure in Reducing Pain Due to Intramuscular Injection in the Emergency Department: A Single-Blind, Randomized Controlled Study

Various non-pharmacological approaches are used in the relief of pain caused by intramuscular injection. Shotblocher and acupressure, which are among these methods, are easy to apply.More evidence-based studies are needed to fully understand the effectiveness of acupressure an d shotblocher in reducing pain associated with intramuscular injection.This study will be conducted to compare the effectiveness of shotblocker and acupressure in reducing pain associated with intramuscular injection in the emergency department.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intramuscular injection is a nursing practice that is frequently used in clinical practice. If intramuscular injection is not performed with correct and appropriate methods, it can cause serious complications. These complications include pain, cellulitis, muscle fibrosis and contracture, sterile abscesses, tissue necrosis, granuloma, intravascular injection, hematoma, and nerve injuries. Although it has healing and therapeutic properties, intramuscular injection can cause pain and discomfort in the patient. Intramuscular injection pain develops due to the mechanical trauma caused by the needle entry and the sudden pressure created when the drug is injected into the muscle. Nurses play an active role in eliminating or reducing the pain that occurs in this process. Pharmacological and non-pharmacological methods are used to reduce pain associated with intramuscular injection. Topical anesthetics, one of the pharmacological methods, are limited in use in emergency services due to their slow analgesic effects, risk of systemic toxicity and local side effects. There are various non-pharmacological methods applied to control pain caused by injection. One of the non-pharmacological methods applied to reduce the pain experienced during intramuscular injection is Shotblocker application. It is reported that ShotBlocker reduces pain by temporarily blocking the peripheral nerve endings by preventing the perception of pain and its transmission to the central nervous system. Another method used to reduce pain due to injection is acupressure. Experimental and clinical evidence suggests that acupressure may relieve pain and promote relaxation. In addition, this non-invasive application involves minimal risk and can be easily integrated into the application. Acupressure points such as UB31, UB32, UB33 and UB34 are stated to be beneficial for low back pain, hernia, dysmenorrhea, dysuria, pain. Of these, UB32 and UB31 are clinically frequently used acupressure points. In this study, the UB32 acupressure point will be used to reduce the pain associated with multiple injections.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those who are admitted to the emergency room for the administration of prescription drugs or those who are planned to be injected intramuscularly by the emergency room physician
  • Diclofenac sodium (75 mg/3 ml) was ordered to the patient in the emergency department.
  • 18 years and older
  • Patients who have not had an injection in the same area in the last 2 week
  • Having no problems with vision and hearing
  • Does not have a disease that can cause loss of sensation and sensory loss
  • Open to communication and cooperation
  • Patients willing to participate in the study will be included in the study.

Exclusion Criteria:

  • Those who apply to the emergency department with complaints of anxiety or trauma (soft tissue traumas, multiple traumas due to traffic accidents or falls, or bone fractures),
  • Those who experience a change in consciousness,
  • Patients with clinical conditions that require urgent intervention,
  • Infection at the injection site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acupressure
Before the injection, patients will be asked to lie in the prone position. The acupressure point (UB32) will be located on the side to be injected. The UB32 point is located in the sacrum region, below the medial and posterior superior iliac spine, in the second sacral foramen. The acupressure point UB32 will be pressed circularly with a stopwatch for 1 minute. Then the acupressure point will be pressed three times in sequence with the thumb directly (pressure equal to 4.5 kg/cm2). Diclofenac sodium (75mg/3ml) will be injected after acupressure.
Other: acupressure application
Acupressure will be applied to the UB32 point
Experimental: Shotblocher
Before the injection, patients will be asked to lie in the prone position. The protruding surface of the Shotblocker will be placed in the area just before the injection so that the point of entry with the needle will not be contaminated. Pressure will be applied by keeping the Shotblocker constant throughout the process. The injector will be quickly inserted through the gap in the middle of the shortblocher. Shotblocker will be removed after drug administration.
Device: Shotblocher
Shotblocher will be administered during injection
No Intervention: Control group
No intervention will be applied before the injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual analog scale
Time Frame: 2 minutes
The visual analog scale will be used to assess the patient's pain intensity. It is a self-reported scale in the form of a 10-cm ruler indicating no pain at one end and unbearable pain at the other. Accordingly, the patient is told to evaluate his/her pain between 0 and 10, with 0 indicating "no pain" and 10 indicating "unbearable pain
2 minutes
Verbal category scale
Time Frame: 2 minutes
The verbal category scale is a one-dimensional, simple, descriptive scale. Patients are asked to state the most appropriate word to describe their pain while filling in the scale. To describe the severity of pain, the patients had to choose from among (1) mild, (2) disturbing, (3) severe, (4) very severe, and (5) unbearable 5. The verbal category scale is a one-dimensional, simple, descriptive scale. Patients are asked to state the most appropriate word to describe their pain while filling in the scale. To describe the severity of pain, the patients had to choose from among (1) mild, (2) disturbing, (3) severe, (4) very severe, and (5) unbearable
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • tulay23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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