Injection FearNCT05577832
Testing Different Methods of Intramuscular Injection
A study testing Helfer Skin Tap Technique, ShotBlocker Technique and Standard Technique in people with Injection Fear and Injection Site Bruising, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare in different injection techniques. The main question[s] it aims to answer are: Is there a difference between the pain levels due to needle insertion in the injection made with the HST Technique, the ShotBlocker technique and the standard technique? Is there a difference… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injection Fear, Injection Site Bruising, Pain, Acute
- What is being tested?
- Helfer Skin Tap Technique, ShotBlocker Technique and Standard Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 25 Dec 2023
- 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
- be over 18 years old
- Having intramuscular Dodex 1 ml amp injection treatment once a week for at least 3 consecutive weeks
- Not using anticoagulant drugs
- Absence of scarring, incision, lipodystrophy, infection at the injection site
- Absence of a history of drug allergy
- Absence of any disease that prevents perception of pain, fear and similar variables (vision, hearing, loss of sensation, cognitive disability, stroke, DM)
Show all 10Show fewer
- Not using centrally or peripherally effective analgesics or sedatives
- Lack of arm limbs
- Body mass index within normal limits
- Prescribing Dodex amp 1 ml
Who cannot join
- Failure to show up 3 times for injection administration
- Drug-induced allergy development
- The patient's desire to withdraw from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing Different Methods of Intramuscular Injection : A Randomized Controlled Study
The goal of this clinical trial is to compare in different injection techniques. The main question[s] it aims to answer are:
- Is there a difference between the pain levels due to needle insertion in the injection made with the HST Technique, the ShotBlocker technique and the standard technique?
- Is there a difference between the hematoma levels of the injection made with the HST Technique, the ShotBlocker technique and the standard technique?
- Is there a difference between the comfort levels of the injection made with the HST Technique, ShotBlocker technique and standard technique?
- Is there a difference between the satisfaction levels of the patients with the injection made with the HST Technique, ShotBlocker technique and standard technique?
- Is there a difference between the injection fear levels of patients with HST Technique, ShotBlocker technique and standard technique?
Read the detailed description
Type of Research This project is a randomized controlled trial. Place and Time of Research The research will be carried out with patients who applied to the emergency department of Atatürk University Research Hospital for IM injection between January and May 2023.
Population and Sample of the Research The population of the research will be the patients who applied to the emergency department of Atatürk University Research Hospital and were prescribed Dodex 1ml amp for IM injection. The preference of patients who were prescribed Dodex 1ml in the study is due to the fact that the treatment procedure should be administered daily, at first, and then once a week.
Dodex 1ml amp application procedure It is a red colored solution in the form of 1 ml ampoules, used in the treatment of pernicious anemia, hyperchromic macrocytic anemia, neuralgia, neuritis, sciatica, containing cyanocobalamin, that is, vitamin B12. The reason for choosing Dodex treatment is that it is a frequently used drug, it is a suitable drug (1 ml) to be applied to the deltoid region, and a certain part of the treatment is done once a week. 1 ml ampoule of Dodex In anemia due to vitamin B12 deficiency, treatment is started with 250-1000 mcg vitamin B12 4/7 application every other day and this application is continued for 1-2 weeks. Then, 250 mcg of vitamin B12 is administered once a week until the results of the blood tests prove that normalcy has returned.
Ordering the Application to the Research Group As a result of the power analysis, 40 people are planned to be included in the study. Since 3 different applications will be evaluated once a week for 1 weeks(3 day), it is planned to apply the methods to be applied to the patients in a randomized order in order to avoid bias in the research. The researcher classified the methods as A, B, C. In order to determine which methods A, B, C would be, he wrote the names of the methods on 3 pieces of paper and drew them in order. In this direction; Method A: HST Technique, Method B: Standard Technique, Method C was chosen as the Shotbocker Technique. Methods A, B, C were classified as ABC, ACB, BAC, BCA, CAB, CBA, respectively. In the same way, the researcher wrote these methods on 6 papers and drew them in order. Thus, he determined the order of methods to be applied to the patient group. ACB, BAC, CAB, BCA, CBA, ABC rankings were drawn, respectively. The order of application of the methods was determined according to the order of the patients to be included in the study.
Method A: HST Process Steps
- Checking the physician's order.
- Confirming the identity of the patient, the name of the drug, the dose, route and time of administration.
- Obtaining information from the patient about his/her allergic status.
- Checking the expiration date of the drug.
- Ensuring hand hygiene.
- Preparing the correct dose of the drug from the ampoule using the surgical aseptic technique.
- Changing the needle tip
- Patient authentication
- Do not close the room door or pull the curtain at the bedside
- Explaining the purpose of the treatment and the way of application to the patient before the procedure.
- Do not wash your hands and wear disposable gloves.
- Putting the patient in the Fowler position
- Do not cover the patient to expose only the Deltoid region.
- Detection of deltoid region. (In the determination of the deltoid region, a horizontal line will be drawn about one centimeter below the acromion process of the upper arm towards the outer lateral surfaces of the arm, both ends of this imaginary line will be joined at the axillary level to obtain an inverted triangle. The midpoint of the triangle shows the injection point.)
- Cleaning around the injection site with an antiseptic tampon and in circular motions, overflowing the injection site, waiting for the area to dry.
- Removing the needle sheath and holding the syringe between the thumb and forefinger of the active hand.
- -Do not hit the lower part of the injection site, the lower part of the deltoid muscle twice, in a way that does not hurt the patient and does not touch the injection site. In the 3rd tapping process, penetrating the detected area with a needle to synchronize with tapping.
- As soon as the needle is inserted, hold the lower end of the syringe using the thumb and index finger of the passive hand and check for blood by pulling back the plunger with the active hand.
- Holding the plunger with the active hand, injecting the drug at a rate of 10 seconds/ml.
- Wait 10 seconds before withdrawing the needle.
- With the fourth stroke, withdraw the needle straight and steady at the angle entered into the tissue.
- Applying light pressure to the area, without massaging, using a dry gauze or cotton pad.
- Do not throw the needle into the sharps waste box without putting on the sheath of the used needle.
- Gathering the materials and giving the patient a comfortable position.
- Removing gloves and maintaining hand hygiene.
- Saving the application.
- Evaluating and recording the individual's response to the application. Method B: Standard Technical Application Procedure
- Process steps 1-15 in Method A will be applied. 2) Removing the needle sheath and holding the syringe between the thumb and forefinger of the active hand.
- As soon as the needle is inserted, hold the lower end of the syringe using the thumb and forefinger of the passive hand and check for blood by pulling back the plunger with the active hand.
- Injecting the drug at a rate of 10 seconds/ml by holding the plunger with the active hand.
- Wait 10 seconds before retracting the needle. 6) Straight and steady retraction of the needle with the angle inserted into the tissue.
- Process steps 22-27 in Method A will be applied. Method C: Shotblocker Application Procedure
- Process steps 1-15 in Method A will be applied.
- Placing the ShotBlocker device over the deltoid region and applying light pressure on it.
- Removing the needle sheath and holding the syringe between the thumb and forefinger of the active hand.
- Inserting the needle into the tissue from the middle of the ShotBlocker device at an angle of 72-90 degrees.
- As soon as the needle is inserted, hold the lower end of the syringe using the thumb and index finger of the passive hand and check for blood by pulling back the plunger with the active hand.
- Holding the plunger with the active hand, injecting the drug at a rate of 10 seconds/ml.
- Wait 10 seconds before retracting the needle.
- Withdraw the needle straight and steady at the angle entered into the tissue.
- Removing the ShotBlocker device on the deltoid region.
- Process steps 22-27 in Method A will be applied Data Collection Before starting the research, patients will be given information about the purpose, method, etc. of the research, and the "Sociodemographic Characteristics Form" will be filled in with the patients who agree to participate in the research. Three different methods will be applied to the patients once a week. "Visual Comparison Scale", "Comfort Scale", Injection Satisfaction Evaluation Scale", "Pain Level and Duration Record Form", "Injection Fear Scale" and "Injection Application Form" will be prepared for each application separately. These forms will be filled after each application. "Opsite-Flexigrid Measurement Registration Form" will be filled in 48 hours after injection applications.
Analysis of Data The data will be evaluated in the SPSS package program. In the evaluation of the data, the statistical significance value will be accepted as 0.05, the Type 1 error will be kept at 5% and the evaluation will be made with a 95% confidence interval. In order to determine the reliability of the measurement tools, the Cronbach Alpha Value will be examined, and analyzes will continue for measurements above 0.60. Skewness and Kurtosis values will be examined in order to determine whether the measurements show a normal distribution. The data will be analyzed in the light of this information. In intra-group pre-test post-test score comparisons, the t-test for normally distributed measurements will be used for dependent samples, and the Mann-Whitney U test will be used for non-normally-distributed measurements. In order to determine the difference in repeated measurements, one-factor anova for Replicated Measurements will be used for normally distributed measurements, and Friedman test will be used for non-normally distributed measurements. In order to determine from which groups the difference originates, the t-test will be used for normally distributed measurements in dependent groups, and the Wilcoxon Ordered Signs test will be used for non-normally-distributed measurements.
Variables of the Study Independent Variable: Intramuscular injection techniques to be applied to patients (HST, Shotblocker, Standard Technique) Dependent Variables: Patients' pain levels due to needle insertion, drug-induced pain level and pain duration, hematoma frequency and levels, comfort levels, satisfaction levels, injection fear levels.
Limitations of the Research One of the limitations of the study was the inclusion of patients who were prescribed a weekly intramuscular injection of Dodex 1 ml amp.
- Being tested
- Helfer Skin Tap Technique, ShotBlocker Technique, Standard Technique
- Medical subject headings
- Iatrophobia, Acute Pain, Patient Satisfaction, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helfer Skin Tap TechniqueProcedure or surgery
In a single-group design, 3 technique injections will be administered to the patients, to be randomized. The HST technique will be applied to patients in any one of 1days in a randomized fashion.
ShotBlocker TechniqueProcedure or surgery
In a single-group design, 3 technique injections will be administered to the patients, 1 technique per week, to be randomized. The ShotBlocker technique will be applied to patients in any one of 1 weeks(3 days) in a randomized manner.
Standard TechniqueProcedure or surgery
Standard Technique In a single-group design, 3 technique injections will be administered to the patients, 1 technique per days, to be randomized. The standard technique will be applied to patients in any one of 1 weeks in a randomized fashion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 3 different injection techniques in Single Group design, 1 ml intramuscular injection of dodex amp 1 ml will be applied to the deltoid muscle, one technique per week, for 1 weeks(3 day). The effects of the three techniques on pain, satisfaction with hematoma, comfort and fear of injection will be compared. Receives: Procedure: Helfer Skin Tap Technique; Procedure: ShotBlocker Technique; Procedure: Standard Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Patients will be asked to indicate and mark their post-injection pain, comfort, satisfaction, and fear of injection, with a minimum of 1 and a maximum of 10.
Measured: 3 days
Opsite-Flexigrid Measurement Registration Form
The Opsite-Flexigrid Measuring Tool is an easy-to-use film cover with transparent adhesive and moisture permeability. Opsite-Flexigrid consists of a thin polyurethane membrane coated with an acrylic adhesive layer. It is used in the measurement of hematoma diameter due to its small squares and transparency. After each injection, this tape will be attached to the arm of the individual with the injection site exposed, and will be used to determine the presence of hematoma in the individual 48 hours later. It consists of squares of centimeters divided into 10 parts of 0.1mm. Hematoma sizes measured with a transparent tape will be considered as pinpoint = needle tip if a spot-shaped color change has occurred at the needle entry point, medium if it is between 0.2-1 cm2, and large hematoma if it is larger than 1 cm2. The obtained data will be recorded in the form.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 May 2023
- Primary completion31 Aug 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injection FearStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor
- Investigators
- Bahar Çiftçi, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577832
- Sponsor's protocol ID
- MusAlparlanU
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2022
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yildiz GN, Ciftci B. Deltoid muscle intramuscular injection methods examining pain comfort satisfaction and fear in ShotBlocker helfer skin tap and standard techniques. BMC Nurs. 2025 Apr 8;24(1):390. doi: 10.1186/s12912-025-02901-8.
PubMed 40200340
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Different Methods of Intramuscular Injection : A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05577832
- Acronym / sponsor ID
- MusAlparlanU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 13 Oct 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.
The goal of this clinical trial is to compare in different injection techniques. The main question[s] it aims to answer are:
- Is there a difference between the pain levels due to needle insertion in the injection made with the HST Technique, the ShotBlocker technique and the standard technique?
- Is there a difference between the hematoma levels of the injection made with the HST Technique, the ShotBlocker technique and the standard technique?
- Is there a difference between the comfort levels of the injection made with the HST Technique, ShotBlocker technique and standard technique?
- Is there a difference between the satisfaction levels of the patients with the injection made with the HST Technique, ShotBlocker technique and standard technique?
- Is there a difference between the injection fear levels of patients with HST Technique, ShotBlocker technique and standard technique?
Detailed description
Type of Research This project is a randomized controlled trial. Place and Time of Research The research will be carried out with patients who applied to the emergency department of Atatürk University Research Hospital for IM injection between January and May 2023.
Population and Sample of the Research The population of the research will be the patients who applied to the emergency department of Atatürk University Research Hospital and were prescribed Dodex 1ml amp for IM injection. The preference of patients who were prescribed Dodex 1ml in the study is due to the fact that the treatment procedure should be administered daily, at first, and then once a week.
Dodex 1ml amp application procedure It is a red colored solution in the form of 1 ml ampoules, used in the treatment of pernicious anemia, hyperchromic macrocytic anemia, neuralgia, neuritis, sciatica, containing cyanocobalamin, that is, vitamin B12. The reason for choosing Dodex treatment is that it is a frequently used drug, it is a suitable drug (1 ml) to be applied to the deltoid region, and a certain part of the treatment is done once a week. 1 ml ampoule of Dodex In anemia due to vitamin B12 deficiency, treatment is started with 250-1000 mcg vitamin B12 4/7 application every other day and this application is continued for 1-2 weeks. Then, 250 mcg of vitamin B12 is administered once a week until the results of the blood tests prove that normalcy has returned.
Ordering the Application to the Research Group As a result of the power analysis, 40 people are planned to be included in the study. Since 3 different applications will be evaluated once a week for 1 weeks(3 day), it is planned to apply the methods to be applied to the patients in a randomized order in order to avoid bias in the research. The researcher classified the methods as A, B, C. In order to determine which methods A, B, C would be, he wrote the names of the methods on 3 pieces of paper and drew them in order. In this direction; Method A: HST Technique, Method B: Standard Technique, Method C was chosen as the Shotbocker Technique. Methods A, B, C were classified as ABC, ACB, BAC, BCA, CAB, CBA, respectively. In the same way, the researcher wrote these methods on 6 papers and drew them in order. Thus, he determined the order of methods to be applied to the patient group. ACB, BAC, CAB, BCA, CBA, ABC rankings were drawn, respectively. The order of application of the methods was determined according to the order of the patients to be included in the study.
Method A: HST Process Steps
- Checking the physician's order.
- Confirming the identity of the patient, the name of the drug, the dose, route and time of administration.
- Obtaining information from the patient about his/her allergic status.
- Checking the expiration date of the drug.
- Ensuring hand hygiene.
- Preparing the correct dose of the drug from the ampoule using the surgical aseptic technique.
- Changing the needle tip
- Patient authentication
- Do not close the room door or pull the curtain at the bedside
- Explaining the purpose of the treatment and the way of application to the patient before the procedure.
- Do not wash your hands and wear disposable gloves.
- Putting the patient in the Fowler position
- Do not cover the patient to expose only the Deltoid region.
- Detection of deltoid region. (In the determination of the deltoid region, a horizontal line will be drawn about one centimeter below the acromion process of the upper arm towards the outer lateral surfaces of the arm, both ends of this imaginary line will be joined at the axillary level to obtain an inverted triangle. The midpoint of the triangle shows the injection point.)
- Cleaning around the injection site with an antiseptic tampon and in circular motions, overflowing the injection site, waiting for the area to dry.
- Removing the needle sheath and holding the syringe between the thumb and forefinger of the active hand.
- -Do not hit the lower part of the injection site, the lower part of the deltoid muscle twice, in a way that does not hurt the patient and does not touch the injection site. In the 3rd tapping process, penetrating the detected area with a needle to synchronize with tapping.
- As soon as the needle is inserted, hold the lower end of the syringe using the thumb and index finger of the passive hand and check for blood by pulling back the plunger with the active hand.
- Holding the plunger with the active hand, injecting the drug at a rate of 10 seconds/ml.
- Wait 10 seconds before withdrawing the needle.
- With the fourth stroke, withdraw the needle straight and steady at the angle entered into the tissue.
- Applying light pressure to the area, without massaging, using a dry gauze or cotton pad.
- Do not throw the needle into the sharps waste box without putting on the sheath of the used needle.
- Gathering the materials and giving the patient a comfortable position.
- Removing gloves and maintaining hand hygiene.
- Saving the application.
- Evaluating and recording the individual's response to the application. Method B: Standard Technical Application Procedure
- Process steps 1-15 in Method A will be applied. 2) Removing the needle sheath and holding the syringe between the thumb and forefinger of the active hand.
- As soon as the needle is inserted, hold the lower end of the syringe using the thumb and forefinger of the passive hand and check for blood by pulling back the plunger with the active hand.
- Injecting the drug at a rate of 10 seconds/ml by holding the plunger with the active hand.
- Wait 10 seconds before retracting the needle. 6) Straight and steady retraction of the needle with the angle inserted into the tissue.
- Process steps 22-27 in Method A will be applied. Method C: Shotblocker Application Procedure
- Process steps 1-15 in Method A will be applied.
- Placing the ShotBlocker device over the deltoid region and applying light pressure on it.
- Removing the needle sheath and holding the syringe between the thumb and forefinger of the active hand.
- Inserting the needle into the tissue from the middle of the ShotBlocker device at an angle of 72-90 degrees.
- As soon as the needle is inserted, hold the lower end of the syringe using the thumb and index finger of the passive hand and check for blood by pulling back the plunger with the active hand.
- Holding the plunger with the active hand, injecting the drug at a rate of 10 seconds/ml.
- Wait 10 seconds before retracting the needle.
- Withdraw the needle straight and steady at the angle entered into the tissue.
- Removing the ShotBlocker device on the deltoid region.
- Process steps 22-27 in Method A will be applied Data Collection Before starting the research, patients will be given information about the purpose, method, etc. of the research, and the "Sociodemographic Characteristics Form" will be filled in with the patients who agree to participate in the research. Three different methods will be applied to the patients once a week. "Visual Comparison Scale", "Comfort Scale", Injection Satisfaction Evaluation Scale", "Pain Level and Duration Record Form", "Injection Fear Scale" and "Injection Application Form" will be prepared for each application separately. These forms will be filled after each application. "Opsite-Flexigrid Measurement Registration Form" will be filled in 48 hours after injection applications.
Analysis of Data The data will be evaluated in the SPSS package program. In the evaluation of the data, the statistical significance value will be accepted as 0.05, the Type 1 error will be kept at 5% and the evaluation will be made with a 95% confidence interval. In order to determine the reliability of the measurement tools, the Cronbach Alpha Value will be examined, and analyzes will continue for measurements above 0.60. Skewness and Kurtosis values will be examined in order to determine whether the measurements show a normal distribution. The data will be analyzed in the light of this information. In intra-group pre-test post-test score comparisons, the t-test for normally distributed measurements will be used for dependent samples, and the Mann-Whitney U test will be used for non-normally-distributed measurements. In order to determine the difference in repeated measurements, one-factor anova for Replicated Measurements will be used for normally distributed measurements, and Friedman test will be used for non-normally distributed measurements. In order to determine from which groups the difference originates, the t-test will be used for normally distributed measurements in dependent groups, and the Wilcoxon Ordered Signs test will be used for non-normally-distributed measurements.
Variables of the Study Independent Variable: Intramuscular injection techniques to be applied to patients (HST, Shotblocker, Standard Technique) Dependent Variables: Patients' pain levels due to needle insertion, drug-induced pain level and pain duration, hematoma frequency and levels, comfort levels, satisfaction levels, injection fear levels.
Limitations of the Research One of the limitations of the study was the inclusion of patients who were prescribed a weekly intramuscular injection of Dodex 1 ml amp.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Helfer Skin Tap Technique, Procedure: ShotBlocker Technique, Procedure: Standard Technique3 different injection techniques in Single Group design, 1 ml intramuscular injection of dodex amp 1 ml will be applied to the deltoid muscle, one technique per week, for 1 weeks(3 day). The effects of the three techniques on pain, satisfaction with hematoma, comfort and fear of injection will be compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- be over 18 years old
- Having intramuscular Dodex 1 ml amp injection treatment once a week for at least 3 consecutive weeks
- Not using anticoagulant drugs
- Absence of scarring, incision, lipodystrophy, infection at the injection site
- Absence of a history of drug allergy
Key exclusion criteria (3 listed)
- Failure to show up 3 times for injection administration
- Drug-induced allergy development
- The patient's desire to withdraw from the study
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 |
|---|---|---|
| Helfer Skin Tap TechniqueIn a single-group design, 3 technique injections will be administered to the patients, to be randomized. The HST technique will be applied to patients in any one of 1days in a randomized fashion. | Procedure or surgery | Experimental |
| ShotBlocker TechniqueIn a single-group design, 3 technique injections will be administered to the patients, 1 technique per week, to be randomized. The ShotBlocker technique will be applied to patients in any one of 1 weeks(3 days) in a randomized manner. | Procedure or surgery | Experimental |
| Standard TechniqueStandard Technique In a single-group design, 3 technique injections will be administered to the patients, 1 technique per days, to be randomized. The standard technique will be applied to patients in any one of 1 weeks in a randomized fashion. | Procedure or surgery | Experimental |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 3 days
Patients will be asked to indicate and mark their post-injection pain, comfort, satisfaction, and fear of injection, with a minimum of 1 and a maximum of 10.
Opsite-Flexigrid Measurement Registration Form
Time frame: 3 days
The Opsite-Flexigrid Measuring Tool is an easy-to-use film cover with transparent adhesive and moisture permeability. Opsite-Flexigrid consists of a thin polyurethane membrane coated with an acrylic adhesive layer. It is used in the measurement of hematoma diameter due to its small squares and transparency. After each injection, this tape will be attached to the arm of the individual with the injection site exposed, and will be used to determine the presence of hematoma in the individual 48 hours later. It consists of squares of centimeters divided into 10 parts of 0.1mm. Hematoma sizes measured with a transparent tape will be considered as pinpoint = needle tip if a spot-shaped color change has occurred at the needle entry point, medium if it is between 0.2-1 cm2, and large hematoma if it is larger than 1 cm2. The obtained data will be recorded in the form.
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 25 Mar 2024.
- Derived from this study: PubMed 40200340Yildiz GN, Ciftci B. Deltoid muscle intramuscular injection methods examining pain comfort satisfaction and fear in ShotBlocker helfer skin tap and standard techniques. BMC Nurs. 2025 Apr 8;24(1):390. doi: 10.1186/s12912-025-02901-8.
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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.
Bahar Çiftçi study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helfer Skin Tap Technique, ShotBlocker Technique and Standard Technique in people with Injection Fear and Injection Site Bruising, run by Muş Alparslan 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 10 inclusion and 3 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 25 Mar 2024. 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 Analog Scale (VAS) (time frame: 3 days). 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?
On the ClinicalTrials.gov record for NCT05577832, which also lists 1 linked publication.
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 25 Mar 2024.