Testing Different Methods of Intramuscular Injection : A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Muş Alparslan University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS)
Study Overview
Brief 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?
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
- •Not using centrally or peripherally effective analgesics or sedatives
- •Lack of arm limbs
- •Body mass index within normal limits
- •Prescribing Dodex amp 1 ml
Exclusion Criteria
- •Failure to show up 3 times for injection administration
- •Drug-induced allergy development
- •The patient's desire to withdraw from the study
Arms & Interventions
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.
Intervention: Helfer Skin Tap Technique (Procedure)
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.
Intervention: ShotBlocker Technique (Procedure)
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.
Intervention: Standard Technique (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported