Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05577832 |
| Other study ID # |
MusAlparlanU |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
December 25, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Mus Alparlan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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?
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
1. Checking the physician's order.
2. Confirming the identity of the patient, the name of the drug, the dose, route and time
of administration.
3. Obtaining information from the patient about his/her allergic status.
4. Checking the expiration date of the drug.
5. Ensuring hand hygiene.
6. Preparing the correct dose of the drug from the ampoule using the surgical aseptic
technique.
7. Changing the needle tip
8. Patient authentication
9. Do not close the room door or pull the curtain at the bedside
10. Explaining the purpose of the treatment and the way of application to the patient before
the procedure.
11. Do not wash your hands and wear disposable gloves.
12. Putting the patient in the Fowler position
13. Do not cover the patient to expose only the Deltoid region.
14. 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.)
15. Cleaning around the injection site with an antiseptic tampon and in circular motions,
overflowing the injection site, waiting for the area to dry.
16. Removing the needle sheath and holding the syringe between the thumb and forefinger of
the active hand.
17. -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.
18. 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.
19. Holding the plunger with the active hand, injecting the drug at a rate of 10 seconds/ml.
20. Wait 10 seconds before withdrawing the needle.
21. With the fourth stroke, withdraw the needle straight and steady at the angle entered
into the tissue.
22. Applying light pressure to the area, without massaging, using a dry gauze or cotton pad.
23. Do not throw the needle into the sharps waste box without putting on the sheath of the
used needle.
24. Gathering the materials and giving the patient a comfortable position.
25. Removing gloves and maintaining hand hygiene.
26. Saving the application.
27. Evaluating and recording the individual's response to the application. Method B:
Standard Technical Application Procedure
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
1. Process steps 1-15 in Method A will be applied.
2. Placing the ShotBlocker device over the deltoid region and applying light pressure on
it.
3. Removing the needle sheath and holding the syringe between the thumb and forefinger of
the active hand.
4. Inserting the needle into the tissue from the middle of the ShotBlocker device at an
angle of 72-90 degrees.
5. 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.
6. Holding the plunger with the active hand, injecting the drug at a rate of 10 seconds/ml.
7. Wait 10 seconds before retracting the needle.
8. Withdraw the needle straight and steady at the angle entered into the tissue.
9. Removing the ShotBlocker device on the deltoid region.
10. 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.
