Intramuscular InjectionNCT04883723
Effect of Manual Pressure and Shotblocker on Pain and Injection Satisfaction in Intramuscular Injection Application
A study testing Shotblocker and Manual Pressure in people with Intramuscular Injection, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as a single blind randomized controlled experimental study to investigate the effect of manual pressure applied before injection and ShotBlocker's pain and injection satisfaction due to intramuscular injection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intramuscular Injection
- What is being tested?
- Shotblocker and Manual Pressure
- 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
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2019to 23 Aug 2019
- 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
- He has not had an IM injection in the last week,
- Upper respiratory tract infection patients in the Examination Department, where green field patients of the Emergency Service are located,
- Over the age of 18,
- No complications related to IM injections such as pain at the IM injection site, abscess, infection, tissue necrosis, hematoma,
- Does not have pain anywhere in the body that will affect the work result,
- Are conscious and have no communication problem,
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- No vision or hearing problems,
- Not taking analgesic in the last 24 hours,
- Does not have any known chronic disease,
- No psychiatric disorder,
- Diclofenac sodium ampoule has been ordered,
- Can evaluate "Visual Comparison Scale and Injection Satisfaction Scale" correctly,
- Individuals who volunteered to participate in the study and signed the written informed consent form were included.
Who cannot join
- Not wanting to participate in the study,
- Patients who did not meet the study acceptance criteria were not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Use of Manual Pressure and Shotblocker on Pain and Injection Satisfaction in the Application of Intramuscular Injection to the Ventrogluteal Region in Adult Patients
This study was planned as a single blind randomized controlled experimental study to investigate the effect of manual pressure applied before injection and ShotBlocker's pain and injection satisfaction due to intramuscular injection. The sample of the study consisted of a total of 120 patients over the age of 18 who applied to the Emergency Service of a public hospital and were requested Diclofenac Sodium 75mg / 3ml. The patients were included in the experiment I (shotblocker), experiment II (manual compression) and the control group with the randomization list created on the computer.
In the ShotBlocker group, the ShotBlocker was kept throughout the injection, and in the manual compression group, manual pressure was applied to the injection area for 10 seconds before injection, and in the control group, IM injection was applied without using any tools. Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. Visual Comparison Scale and Injection Satisfaction Scale were administered to the patient in the first minute after the injection. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled. Parametric or nonparametric statistical tests and correlation test were used in the analysis of the data.
- Conditions
- Intramuscular Injection
- Being tested
- Shotblocker, Manual Pressure
- Keywords
- shotblocker, manual pressure, İntramuscular injection, pain, injection satisfaction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotblockerDevice
Shotblocker is a small, flat, horseshoe-shaped plastic tool that can be used to reduce pain due to intramuscular injection, suitable for all age groups, without drug properties. It is used by keeping it on the skin surface during injection and has no side effects. Shotblocker has short, non-pointed blunt protrusions on one side that connect with the skin, there is a hole in the middle of the vehicle to expose the injection site. The protruding surface of the vehicle is placed in the area to be applied just before injection. The protrusions on the surface of the Shotblocker do not pierce the skin and provide a warning for the Door Control Theory, which is thought to exist regarding pain
Manual PressureOther
The patient was placed in a prone position and the appropriate left or right ventrogluteal region was determined. Pressure was applied to the determined injection area with the thumb of the active hand for 10 seconds. Immediately after the application of pressure was terminated, the injection site was cleaned with an alcohol cotton pad with circular movements of 5 cm diameter from inside to outside, and the alcohol was allowed to dry. With a single movement at a 90 ° angle, the compression area was entered quickly and the injection was performed. Manual pressure reduces pain within the framework of the gate control theory. According to the gate control theory, when pressure is applied to an area, a fiber transmits the feeling of pressure instead of pain and ultimately the pain sensation is alleviated. There are many studies in the literature that prove the effectiveness of this method.
| Study group | Role | What they receive |
|---|---|---|
| Experiment I (Shotblocker) Group | Experimental | Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. The patient was placed in a prone position. The determined injection site was cleaned with a cotton pad with alcohol, with circular movements of 5 cm diameter from inside to outside, and the alcohol was allowed to dry. The protruding surface of the Shotblocker was placed in the area just before the injection, so that the needle entry point would not be contaminated. It was lightly pressed into the shotblocker with fingertips and the injection was performed. ShotBlocker has been removed after removing the needle. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled. Receives: Device: Shotblocker |
| Experiment II (Manual Pressure) Group | Experimental | Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. The patient was placed in a prone position and the appropriate left or right ventrogluteal region was determined. Pressure was applied to the determined injection area with the thumb of the active hand for 10 seconds. Immediately after the application of pressure was terminated, the injection site was cleaned with an alcohol cotton pad with circular movements of 5 cm diameter from inside to outside and the alcohol was allowed to dry. With a single movement at a 90 ° angle, the compression area was entered quickly and the injection was performed. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled. Receives: Other: Manual Pressure |
| Control Group | No intervention | The patients in the Manual Pressure group were given detailed information about the procedure and the research, and the patients who agreed to participate in the study were signed by an informed consent form. Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. The patient was placed in a prone position and the appropriate left or right ventrogluteal region was determined. Injection was given using the normal intramuscular injection procedure. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Benchmark Scale
It is a one-dimensional scale used in the measurement of pain. It was found that the sensitivity of the visual comparison scale was higher than other methods in the assessment of pain severity. The scale consists of a 100 mm long line. On one end there are the words "No Pain" and "Unbearable Pain" on the other. The patient is instructed to mark a point on the line that accurately reflects his or her pain. Between the onset of no pain and this point marked by the patient, it is measured and recorded.
Measured: Immediately after the injection
Injection Satisfaction Rating Scale
The satisfaction level of the patients after injection was evaluated using a scale consisting of a 100 mm vertical line with "Very Satisfied" on one end and "Not Satisfied" on the other.
Measured: Immediately after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start22 Apr 2019
- Primary completion23 Aug 2019
- Study completion23 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intramuscular InjectionStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- During the data collection, 120 individuals who met the inclusion criteria and were selected with the randomization list created on the computer constituted the sample of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaplan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883723
- Sponsor's protocol ID
- Ali KAPLAN-Erciyes University
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Use of Manual Pressure and Shotblocker on Pain and Injection Satisfaction in the Application of Intramuscular Injection to the Ventrogluteal Region in Adult Patients
- ClinicalTrials.gov ID
- NCT04883723
- Acronym / sponsor ID
- Ali KAPLAN-Erciyes University
- Conditions
- Intramuscular Injection
- Keywords
- shotblocker, manual pressure, İntramuscular injection, pain, injection satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 12 May 2021 (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.
This study was planned as a single blind randomized controlled experimental study to investigate the effect of manual pressure applied before injection and ShotBlocker's pain and injection satisfaction due to intramuscular injection. The sample of the study consisted of a total of 120 patients over the age of 18 who applied to the Emergency Service of a public hospital and were requested Diclofenac Sodium 75mg / 3ml. The patients were included in the experiment I (shotblocker), experiment II (manual compression) and the control group with the randomization list created on the computer.
In the ShotBlocker group, the ShotBlocker was kept throughout the injection, and in the manual compression group, manual pressure was applied to the injection area for 10 seconds before injection, and in the control group, IM injection was applied without using any tools. Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. Visual Comparison Scale and Injection Satisfaction Scale were administered to the patient in the first minute after the injection. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled. Parametric or nonparametric statistical tests and correlation test were used in the analysis of the data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- During the data collection, 120 individuals who met the inclusion criteria and were selected with the randomization list created on the computer constituted the sample of the study.
| Arm | Type | Receives |
|---|---|---|
| Experiment I (Shotblocker) Group | Experimental | Device: ShotblockerBefore the injection, the heart rate and blood pressure values of the patient were measured and recorded. The patient was placed in a prone position. The determined injection site was cleaned with a cotton pad with alcohol, with circular movements of 5 cm diameter from inside to outside, and the alcohol was allowed to dry. The protruding surface of the Shotblocker was placed in the area just before the injection, so that the needle entry point would not be contaminated. It was lightly pressed into the shotblocker with fingertips and the injection was performed. ShotBlocker has been removed after removing the needle. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled. |
| Experiment II (Manual Pressure) Group | Experimental | Other: Manual PressureBefore the injection, the heart rate and blood pressure values of the patient were measured and recorded. The patient was placed in a prone position and the appropriate left or right ventrogluteal region was determined. Pressure was applied to the determined injection area with the thumb of the active hand for 10 seconds. Immediately after the application of pressure was terminated, the injection site was cleaned with an alcohol cotton pad with circular movements of 5 cm diameter from inside to outside and the alcohol was allowed to dry. With a single movement at a 90 ° angle, the compression area was entered quickly and the injection was performed. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled. |
| Control Group | No intervention | –The patients in the Manual Pressure group were given detailed information about the procedure and the research, and the patients who agreed to participate in the study were signed by an informed consent form. Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. The patient was placed in a prone position and the appropriate left or right ventrogluteal region was determined. Injection was given using the normal intramuscular injection procedure. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- He has not had an IM injection in the last week,
- Upper respiratory tract infection patients in the Examination Department, where green field patients of the Emergency Service are located,
- Over the age of 18,
- No complications related to IM injections such as pain at the IM injection site, abscess, infection, tissue necrosis, hematoma,
- Does not have pain anywhere in the body that will affect the work result,
Key exclusion criteria (2 listed)
- Not wanting to participate in the study,
- Patients who did not meet the study acceptance criteria were not included.
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 |
|---|---|---|
| ShotblockerShotblocker is a small, flat, horseshoe-shaped plastic tool that can be used to reduce pain due to intramuscular injection, suitable for all age groups, without drug properties. It is used by keeping it on the skin surface during injection and has no side effects. Shotblocker has short, non-pointed blunt protrusions on one side that connect with the skin, there is a hole in the middle of the vehicle to expose the injection site. The protruding surface of the vehicle is placed in the area to be applied just before injection. The protrusions on the surface of the Shotblocker do not pierce the skin and provide a warning for the Door Control Theory, which is thought to exist regarding pain | Device | Experiment I (Shotblocker) Group |
| Manual PressureThe patient was placed in a prone position and the appropriate left or right ventrogluteal region was determined. Pressure was applied to the determined injection area with the thumb of the active hand for 10 seconds. Immediately after the application of pressure was terminated, the injection site was cleaned with an alcohol cotton pad with circular movements of 5 cm diameter from inside to outside, and the alcohol was allowed to dry. With a single movement at a 90 ° angle, the compression area was entered quickly and the injection was performed. Manual pressure reduces pain within the framework of the gate control theory. According to the gate control theory, when pressure is applied to an area, a fiber transmits the feeling of pressure instead of pain and ultimately the pain sensation is alleviated. There are many studies in the literature that prove the effectiveness of this method. | Other | Experiment II (Manual Pressure) Group |
Primary outcome
Visual Benchmark Scale
Time frame: Immediately after the injection
It is a one-dimensional scale used in the measurement of pain. It was found that the sensitivity of the visual comparison scale was higher than other methods in the assessment of pain severity. The scale consists of a 100 mm long line. On one end there are the words "No Pain" and "Unbearable Pain" on the other. The patient is instructed to mark a point on the line that accurately reflects his or her pain. Between the onset of no pain and this point marked by the patient, it is measured and recorded.
Injection Satisfaction Rating Scale
Time frame: Immediately after the injection
The satisfaction level of the patients after injection was evaluated using a scale consisting of a 100 mm vertical line with "Very Satisfied" on one end and "Not Satisfied" on the other.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shotblocker and Manual Pressure in people with Intramuscular Injection, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 13 inclusion and 2 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: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Benchmark Scale (time frame: Immediately after the injection). 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 May 2021.