- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05456945
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
120
Phase
- 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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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
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
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)
July 20, 2022
Primary Completion (Anticipated)
September 30, 2022
Study Completion (Anticipated)
October 30, 2022
Study Registration Dates
First Submitted
July 10, 2022
First Submitted That Met QC Criteria
July 10, 2022
First Posted (Actual)
July 13, 2022
Study Record Updates
Last Update Posted (Actual)
July 13, 2022
Last Update Submitted That Met QC Criteria
July 10, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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