InjectionsNCT04851158
Effectiveness of Two Different Methods During Intramuscular Antibiotic Injection: ShotBlocker, Local Vibration
A study testing Effectiveness of ShotBlocker on the perceived pain and satisfaction during intramuscular antibiotic injection and Effectiveness of local vibrator device on the perceived pain and satisfaction during intramuscular antibiotic injection in people with Injections and Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
In intramuscular injection applications, which are among the responsibilities and basic skills of nurses, different methods are used to reduce the pain caused by injection and increase the individual's satisfaction. ShotBlocker and local vibration are among the methods used for this purpose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injections, Pain, Satisfaction, Patient
- What is being tested?
- Effectiveness of ShotBlocker on the perceived pain and satisfaction during intramuscular antibiotic injection and Effectiveness of local vibrator device on the perceived pain and satisfaction during intramuscular antibiotic injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2021to 30 May 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over the age of 18, Having no communication problem such as seeing, hearing and understanding problem,
- Having no disease that can cause sensory loss,
- Not having had IM injection in the last week, Having no complication related to IM injections such as pain, abscess, infection, tissue necrosis, and hematoma at the injection site.
Who cannot join
- Patients who do not meet the inclusion criteria will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Emergency Medicine Clinic
Göztepe, Istanbul, 34035
About this study
Official title: Effectiveness of Two Different Methods on the Perceived Pain and Satisfaction During Intramuscular Antibiotic Injection: ShotBlocker and Local Vibration
In intramuscular injection applications, which are among the responsibilities and basic skills of nurses, different methods are used to reduce the pain caused by injection and increase the individual's satisfaction. ShotBlocker and local vibration are among the methods used for this purpose. The aim of the study is to examine the effectiveness of ShotBlocker and local vibration, which are among the non-pharmacological methods, on the perceived pain and satisfaction during ventrogluteal intramuscular antibiotic injection.
This randomized, controlled experimental study will be carried out in the adult emergency clinic of a training and research hospital in Istanbul between February and April 2021.
Read the detailed description
The purpose of study was to evaluate four research hypotheses as follows:
H1: Using ShotBlocker during intramuscular antibiotic injection reduces the patient's injection pain.
H2: Using ShotBlocker during intramuscular antibiotic injection increases the patient's satisfaction with the injection.
H3: Using a local vibrator device during intramuscular antibiotic injection reduces the patient's injection pain.
H4: Using a local vibrator device during intramuscular antibiotic injection increases the patient's satisfaction with the injection.
Sampling of the Research: The sample number was determined at the 0.5 effect size and 0.05 error level with the power analysis performed by taking into account the numerical values of the findings obtained from a previous study on this subject. ShotBlocker group: 35; Local vibration group: 35, Control Group: 35 people.
The sample of the study will consist of volunteer patients who apply to the adult emergency department, who are administered antibiotics (amoxicillin / cefuroxime sodium) upon the physician's request, and who meet the inclusion criteria.
Data Collection Tools: Research data will be collected using the Structured Information Form created by the researchers, VAS Pain and VAS Satisfaction Scales.
Structured Information Form; Five questions regarding the descriptive characteristics of the participants (age, gender, body mass index (BMI), educational status, marital status) were included. BMI (kg/m2) of the participants will be calculated by the researcher.
Procedure:
- Initial Assessment: Verbal information will be given to the participants and their written consents will be obtained prior to the intramuscular injection. The "Structured Information Form" consisting of five questions will be applied by face to face interview method, BMI will be calculated by measuring height and weight and recorded in the "Structured Information Form". ShotBlocker is a patented tool developed by Bionix (Toledo, OH, United States). It is a small, flat, horseshoe (U-shaped) shaped plastic tool with a thickness of 2 mm, which is used for pain control in intramuscular and subcutaneous injections, suitable for all age groups, has no known side effects, does not have drug properties, is non-invasive. Since it is not an invasive device, it is stated by the manufacturer that it can be used several times for the same patient after washing with soap. The protruding surface of the vehicle is placed in the area to be applied just before injection. Short blunt bumps on the surface of the vehicle do not pierce the skin. Local Vibrator one of the electric vibrator devices (dolphin massager device, 210-240 V, 50 Hz) produced by different brands was used. These devices with interchangeable heads have the ability to affect deep muscle groups, stimulate nerve endings and accelerate blood circulation thanks to mechanical vibration. During application, the device must be in full contact with the skin. Local vibration application reduces perceived pain by stimulating nerve fibers according to Melzack and Wall's Gate Control Theory.
- Application: Before the drug is prepared, the physician's request will be checked by the researcher. Hands will be washed, the drug (amoxicillin / cefuroxime sodium) will be prepared by diluting with 4 ml of water for injection, the needle tip will be changed to 21G (0.8x40mm - green). The patient will be verbally informed, and the drug allergy status will be questioned. The patient will be asked to lie down in the prone position. The skin surface in the area where the IM injection will be applied will be observed by the researching specialist nurse for ecchymosis, scar, inflammation or edema. The presence of tenderness or stiffness will be evaluated by palpation, paying attention to muscle integrity. To the patient group who was applied local vibration; Before injection, local vibration will be applied to the region with a vibrator for five minutes, guided by a previous study on this subject. Afterwards, the skin will be cleaned using 70% alcohol and the injection will be applied with the appropriate technique, and then a light pressure will be applied to the area with a cotton pad for 15-20 seconds. For the patient group treated with ShotBlocker; After skin cleaning, the protruding surface of the vehicle will be placed facing the skin surface and the injection will be applied with the appropriate technique, then ShotBlocker will be removed and a light pressure will be applied to the area with a cotton pad for 15-20 seconds. In the control group; IM injection into the ventrogluteal area will be performed with the appropriate technique without using any tools.
- Final Assessment:
The change from baseline in pain and satisfaction scores on the Visual Analogue Scale (VAS) will be measured immediately after intramuscular injection using VAS.
Ethical Considerations: The ethical compliance of the study was approved by the Istanbul Medeniyet University Goztepe Training and Research Hospital clinical research ethics committee (date and number: 10.02.2021/0067). Written institutional permission was obtained. After the purpose and duration of the study is explained, written informed consent is obtained from the patients on a voluntary basis.
Statistical Analyses: Data will be analyzed using SPSS (Statistical Package for Social Sciences, Chicago, Illinois) version 16.0.
Note: The research is not supported by any institution or organization.
- Conditions
- Injections, Pain, Satisfaction, Patient
- Being tested
- Effectiveness of ShotBlocker on the perceived pain and satisfaction during intramuscular antibiotic injection, Effectiveness of local vibrator device on the perceived pain and satisfaction during intramuscular antibiotic injection
- Keywords
- Intramuscular injection, pain, ShotBlocker, local vibration, nursing
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effectiveness of ShotBlocker on the perceived pain and satisfaction during intramuscular antibiotic injectionDevice
Intervention: Verbal information was given to the participants prior to the intramuscular injection, and their written consents were obtained. The "Structured Information Form" consisting of five questions was applied by face-to-face interview method. Height and weight were measured, and BMI (kg/m2) was calculated and recorded in the "Structured Information Form".
Application: ShotBlocker will be used on 35 patients during intramuscular injection.
Final assessment: VAS will be applied immediately after the intramuscular injection to determine the pain and satisfaction levels of the participants.
Effectiveness of local vibrator device on the perceived pain and satisfaction during intramuscular antibiotic injectionDevice
Intervention: Verbal information was given to the participants prior to the intramuscular injection, and their written consents were obtained. The "Structured Information Form" consisting of five questions was applied by face-to-face interview method. Height and weight were measured, and BMI (kg/m2) was calculated and recorded in the "Structured Information Form".
Application: Local vibrator device will be used on 35 patients during intramuscular injection.
Final assessment: VAS will be applied immediately after the intramuscular injection to determine the pain and satisfaction levels of the participants.
| Study group | Role | What they receive |
|---|---|---|
| ShotBlocker | Experimental | ShotBlocker will be used on 35 patients. For the patient group that is applied ShotBlocker, after cleansing the skin, the protruding surface of the device is placed facing the skin surface. The injection is applied with the appropriate technique, then ShotBlocker is removed and a light pressure is applied to the area with a cotton pad for 15-20 seconds. Receives: Device: Effectiveness of ShotBlocker on the perceived pain and satisfaction during intramuscular antibiotic injection |
| Local Vibration | Experimental | Local Vibration will be used on 35 patients. For the patient group that was subject to local vibration, local vibration was applied to the region with a vibrator for five minutes prior to injection, following a previous study on this subject. After that, 70% alcohol was used to cleanse the skin. The injection was applied with the appropriate technique, then a light pressure was applied to the area with a cotton pad for 15-20 seconds. Receives: Device: Effectiveness of local vibrator device on the perceived pain and satisfaction during intramuscular antibiotic injection |
| Control | No intervention | For the control group (n=35), IM injection into the ventrogluteal region without using any tools is performed with the appropriate technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using ShotBlocker and local vibrator device during intramuscular antibiotic injection reduces the patient's injection related pain.
The change from baseline in pain scores will be measured immediately after intramuscular injection using Visual Analogue Scale (VAS) for pain. On a ten-centimetre long horizontal line, there are definitions of "no pain" at the left end and "unbearable pain" at the right end. High scores indicate a high level of pain.
Measured: The procedure will take a total of 10 minutes.
Using ShotBlocker and local vibrator device during intramuscular antibiotic injection increases the patient's injection related satisfaction.
The change from baseline in satisfaction scores will be measured immediately after intramuscular injection using Visual Analogue Scale (VAS) for satisfaction. On a ten-centimetre long vertical line, there is the statement "Strongly dissatisfied" at the lower end of the line, and "Strongly satisfied" at the upper end. High scores indicate a high level of satisfaction.
Measured: The procedure will take a total of 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start20 Apr 2021
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjectionsStudies of the same condition, open and under way.
- 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
- Model description
- The sample size was determined as 35 persons for each group at the 0.5 effect size and 0.05 error level with the power analysis performed by taking into account the numerical values of the findings obtained from a previous study on this subject. ShotBlocker group:35; Local vibration group: 35; Control group:35 person
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemile Savcı, Istanbul Medeniyet University
- Investigators
- Kurtuluş Açıksarı, Study chair, Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Emergency Medicine ClinicAlper Solakoğlu, Principal investigator, Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Emergency Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851158
- Sponsor's protocol ID
- 20210067
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Different Methods on the Perceived Pain and Satisfaction During Intramuscular Antibiotic Injection: ShotBlocker and Local Vibration
- ClinicalTrials.gov ID
- NCT04851158
- Acronym / sponsor ID
- 20210067
- Conditions
- Injections, Pain, Satisfaction, Patient
- Keywords
- Intramuscular injection, pain, ShotBlocker, local vibration, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 20 Apr 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.
In intramuscular injection applications, which are among the responsibilities and basic skills of nurses, different methods are used to reduce the pain caused by injection and increase the individual's satisfaction. ShotBlocker and local vibration are among the methods used for this purpose. The aim of the study is to examine the effectiveness of ShotBlocker and local vibration, which are among the non-pharmacological methods, on the perceived pain and satisfaction during ventrogluteal intramuscular antibiotic injection.
This randomized, controlled experimental study will be carried out in the adult emergency clinic of a training and research hospital in Istanbul between February and April 2021.
Detailed description
The purpose of study was to evaluate four research hypotheses as follows:
H1: Using ShotBlocker during intramuscular antibiotic injection reduces the patient's injection pain.
H2: Using ShotBlocker during intramuscular antibiotic injection increases the patient's satisfaction with the injection.
H3: Using a local vibrator device during intramuscular antibiotic injection reduces the patient's injection pain.
H4: Using a local vibrator device during intramuscular antibiotic injection increases the patient's satisfaction with the injection.
Sampling of the Research: The sample number was determined at the 0.5 effect size and 0.05 error level with the power analysis performed by taking into account the numerical values of the findings obtained from a previous study on this subject. ShotBlocker group: 35; Local vibration group: 35, Control Group: 35 people.
The sample of the study will consist of volunteer patients who apply to the adult emergency department, who are administered antibiotics (amoxicillin / cefuroxime sodium) upon the physician's request, and who meet the inclusion criteria.
Data Collection Tools: Research data will be collected using the Structured Information Form created by the researchers, VAS Pain and VAS Satisfaction Scales.
Structured Information Form; Five questions regarding the descriptive characteristics of the participants (age, gender, body mass index (BMI), educational status, marital status) were included. BMI (kg/m2) of the participants will be calculated by the researcher.
Procedure:
- Initial Assessment: Verbal information will be given to the participants and their written consents will be obtained prior to the intramuscular injection. The "Structured Information Form" consisting of five questions will be applied by face to face interview method, BMI will be calculated by measuring height and weight and recorded in the "Structured Information Form". ShotBlocker is a patented tool developed by Bionix (Toledo, OH, United States). It is a small, flat, horseshoe (U-shaped) shaped plastic tool with a thickness of 2 mm, which is used for pain control in intramuscular and subcutaneous injections, suitable for all age groups, has no known side effects, does not have drug properties, is non-invasive. Since it is not an invasive device, it is stated by the manufacturer that it can be used several times for the same patient after washing with soap. The protruding surface of the vehicle is placed in the area to be applied just before injection. Short blunt bumps on the surface of the vehicle do not pierce the skin. Local Vibrator one of the electric vibrator devices (dolphin massager device, 210-240 V, 50 Hz) produced by different brands was used. These devices with interchangeable heads have the ability to affect deep muscle groups, stimulate nerve endings and accelerate blood circulation thanks to mechanical vibration. During application, the device must be in full contact with the skin. Local vibration application reduces perceived pain by stimulating nerve fibers according to Melzack and Wall's Gate Control Theory.
- Application: Before the drug is prepared, the physician's request will be checked by the researcher. Hands will be washed, the drug (amoxicillin / cefuroxime sodium) will be prepared by diluting with 4 ml of water for injection, the needle tip will be changed to 21G (0.8x40mm - green). The patient will be verbally informed, and the drug allergy status will be questioned. The patient will be asked to lie down in the prone position. The skin surface in the area where the IM injection will be applied will be observed by the researching specialist nurse for ecchymosis, scar, inflammation or edema. The presence of tenderness or stiffness will be evaluated by palpation, paying attention to muscle integrity. To the patient group who was applied local vibration; Before injection, local vibration will be applied to the region with a vibrator for five minutes, guided by a previous study on this subject. Afterwards, the skin will be cleaned using 70% alcohol and the injection will be applied with the appropriate technique, and then a light pressure will be applied to the area with a cotton pad for 15-20 seconds. For the patient group treated with ShotBlocker; After skin cleaning, the protruding surface of the vehicle will be placed facing the skin surface and the injection will be applied with the appropriate technique, then ShotBlocker will be removed and a light pressure will be applied to the area with a cotton pad for 15-20 seconds. In the control group; IM injection into the ventrogluteal area will be performed with the appropriate technique without using any tools.
- Final Assessment:
The change from baseline in pain and satisfaction scores on the Visual Analogue Scale (VAS) will be measured immediately after intramuscular injection using VAS.
Ethical Considerations: The ethical compliance of the study was approved by the Istanbul Medeniyet University Goztepe Training and Research Hospital clinical research ethics committee (date and number: 10.02.2021/0067). Written institutional permission was obtained. After the purpose and duration of the study is explained, written informed consent is obtained from the patients on a voluntary basis.
Statistical Analyses: Data will be analyzed using SPSS (Statistical Package for Social Sciences, Chicago, Illinois) version 16.0.
Note: The research is not supported by any institution or organization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The sample size was determined as 35 persons for each group at the 0.5 effect size and 0.05 error level with the power analysis performed by taking into account the numerical values of the findings obtained from a previous study on this subject. ShotBlocker group:35; Local vibration group: 35; Control group:35 person
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker | Experimental | Device: Effectiveness of ShotBlocker on the perceived pain and satisfaction during intramuscular antibiotic injectionShotBlocker will be used on 35 patients. For the patient group that is applied ShotBlocker, after cleansing the skin, the protruding surface of the device is placed facing the skin surface. The injection is applied with the appropriate technique, then ShotBlocker is removed and a light pressure is applied to the area with a cotton pad for 15-20 seconds. |
| Local Vibration | Experimental | Device: Effectiveness of local vibrator device on the perceived pain and satisfaction during intramuscular antibiotic injectionLocal Vibration will be used on 35 patients. For the patient group that was subject to local vibration, local vibration was applied to the region with a vibrator for five minutes prior to injection, following a previous study on this subject. After that, 70% alcohol was used to cleanse the skin. The injection was applied with the appropriate technique, then a light pressure was applied to the area with a cotton pad for 15-20 seconds. |
| Control | No intervention | –For the control group (n=35), IM injection into the ventrogluteal region without using any tools is performed with the appropriate technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being over the age of 18, Having no communication problem such as seeing, hearing and understanding problem,
- Having no disease that can cause sensory loss,
- Not having had IM injection in the last week, Having no complication related to IM injections such as pain, abscess, infection, tissue necrosis, and hematoma at the injection site.
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion criteria will be excluded.
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 |
|---|---|---|
| Effectiveness of ShotBlocker on the perceived pain and satisfaction during intramuscular antibiotic injectionIntervention: Verbal information was given to the participants prior to the intramuscular injection, and their written consents were obtained. The "Structured Information Form" consisting of five questions was applied by face-to-face interview method. Height and weight were measured, and BMI (kg/m2) was calculated and recorded in the "Structured Information Form". Application: ShotBlocker will be used on 35 patients during intramuscular injection. Final assessment: VAS will be applied immediately after the intramuscular injection to determine the pain and satisfaction levels of the participants. | Device | ShotBlocker |
| Effectiveness of local vibrator device on the perceived pain and satisfaction during intramuscular antibiotic injectionIntervention: Verbal information was given to the participants prior to the intramuscular injection, and their written consents were obtained. The "Structured Information Form" consisting of five questions was applied by face-to-face interview method. Height and weight were measured, and BMI (kg/m2) was calculated and recorded in the "Structured Information Form". Application: Local vibrator device will be used on 35 patients during intramuscular injection. Final assessment: VAS will be applied immediately after the intramuscular injection to determine the pain and satisfaction levels of the participants. | Device | Local Vibration |
Primary outcome
Using ShotBlocker and local vibrator device during intramuscular antibiotic injection reduces the patient's injection related pain.
Time frame: The procedure will take a total of 10 minutes.
The change from baseline in pain scores will be measured immediately after intramuscular injection using Visual Analogue Scale (VAS) for pain. On a ten-centimetre long horizontal line, there are definitions of "no pain" at the left end and "unbearable pain" at the right end. High scores indicate a high level of pain.
Using ShotBlocker and local vibrator device during intramuscular antibiotic injection increases the patient's injection related satisfaction.
Time frame: The procedure will take a total of 10 minutes.
The change from baseline in satisfaction scores will be measured immediately after intramuscular injection using Visual Analogue Scale (VAS) for satisfaction. On a ten-centimetre long vertical line, there is the statement "Strongly dissatisfied" at the lower end of the line, and "Strongly satisfied" at the upper end. High scores indicate a high level of satisfaction.
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 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Kurtuluş Açıksarı study chair
Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Emergency Medicine Clinic
Alper Solakoğlu principal investigator
Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Emergency Medicine Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effectiveness of ShotBlocker on the perceived pain and satisfaction during intramuscular antibiotic injection and Effectiveness of local vibrator device on the perceived pain and satisfaction during intramuscular antibiotic injection in people with Injections and Pain, run by Istanbul Medeniyet 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 3 inclusion and 1 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 Mar 2023. 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?
Using ShotBlocker and local vibrator device during intramuscular antibiotic injection reduces the patient's injection related pain. (time frame: The procedure will take a total of 10 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 Mar 2023.