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

Primary Purpose

Acute Pain, İnjection, Acupressure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupressure application
Shotblocher
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Acupressure

    Shotblocher

    Control group

    Arm Description

    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.

    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.

    No intervention will be applied before the injection

    Outcomes

    Primary Outcome Measures

    Visual analog scale
    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
    Verbal category scale
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 10, 2022
    Last Updated
    July 10, 2022
    Sponsor
    Ataturk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05456945
    Brief Title
    Comparison of the Efficacy of Shotblocker and Acupressure in Reducing Pain Due to Intramuscular Injection
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 20, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2022 (Anticipated)
    Study Completion Date
    October 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ataturk University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pain, İnjection, Acupressure, Alternative Medicine

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupressure
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Shotblocher
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No intervention will be applied before the injection
    Intervention Type
    Other
    Intervention Name(s)
    acupressure application
    Intervention Description
    Acupressure will be applied to the UB32 point
    Intervention Type
    Device
    Intervention Name(s)
    Shotblocher
    Intervention Description
    Shotblocher will be administered during injection
    Primary Outcome Measure Information:
    Title
    Visual analog scale
    Description
    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
    Time Frame
    2 minutes
    Title
    Verbal category scale
    Description
    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
    Time Frame
    2 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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

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