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| Name | Class |
|---|---|
| Ataturk University | OTHER |
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The goal of this clinical trial is to compare in different injection techniques. The main question[s] it aims to answer are:
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
1) 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.
3) 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.
4) Injecting the drug at a rate of 10 seconds/ml by holding the plunger with the active hand.
5) Wait 10 seconds before retracting the needle. 6) Straight and steady retraction of the needle with the angle inserted into the tissue.
7) Process steps 22-27 in Method A will be applied. Method C: Shotblocker Application Procedure
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helfer Skin Tap Technique | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bahar Çiftçi | Ataturk University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atatürk University | Erzurum | Erzusum | 25100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40200340 | Derived | 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. |
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| ID | Term |
|---|---|
| C000719205 | Iatrophobia |
| D059787 | Acute Pain |
| D017060 | Patient Satisfaction |
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ShotBlocker Technique | Procedure | 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 Technique | Procedure | 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. |
|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |