Acute PainNCT05456945
Comparison of the Efficacy of Shotblocker and Acupressure in Reducing Pain Due to Intramuscular Injection
A study testing acupressure application and Shotblocher in people with Acute Pain and İnjection, run by Ataturk University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, İnjection, Acupressure
- What is being tested?
- acupressure application and Shotblocher
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Acute Pain, İnjection, Acupressure, Alternative Medicine
- Being tested
- acupressure application, Shotblocher
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure applicationOther
Acupressure will be applied to the UB32 point
ShotblocherDevice
Shotblocher will be administered during injection
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | 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. Receives: Other: acupressure application |
| Shotblocher | Experimental | 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. Receives: Device: Shotblocher |
| Control group | No intervention | No intervention will be applied before the injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 minutes
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
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start20 Jul 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülay KILINÇ, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456945
- Sponsor's protocol ID
- tulay23
- Status last verified
- Jul 2022
- First submitted
- 10 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05456945
- Acronym / sponsor ID
- tulay23
- Conditions
- Acute Pain, İnjection, Acupressure, Alternative Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 20 Jul 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Other: acupressure applicationBefore 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. |
| Shotblocher | Experimental | Device: ShotblocherBefore 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. |
| Control group | No intervention | –No intervention will be applied before the injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressure applicationAcupressure will be applied to the UB32 point | Other | Acupressure |
| ShotblocherShotblocher will be administered during injection | Device | Shotblocher |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure application and Shotblocher in people with Acute Pain and İnjection, run by Ataturk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: 2 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.