An interventional study of ShotBlocker in Patients Above 18 Years, sponsored by Yağmur SÜRMELİ. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Yağmur SÜRMELİ · Not applicable, Interventional, and Supportive care
This randomized, double-blind study aimed to determine the effect of ShotBlocker on IMI pain in adult patients who received diclofenac sodium and metamizole sodium as IMI in the emergency department. The main question(s) it aims to answer are as follows:
The study is planned to be conducted between October 2024 and December 2024. The population of the study will consist of adult patients who have applied to the emergency department of a state hospital in Turkey between October 2024 and December 2024 due to the use of previously prescribed drugs (diclofenac sodium and metamizole sodium) or who need to be administered IMI diclofenac sodium and metamizole sodium upon the order of the emergency room physician. The minimum sample size expected to complete the data collection form of the study was calculated with G power analysis at a 95% confidence level before the data collection phase. Accordingly, the sample size required for the study was determined as 25 for each group, with an alpha value of 0.01, an effect size of 1.583, and a theoretical power of 99% [23]. In case of sample loss during the study, it was planned to take 20% more samples than the calculated sample and to include 30 people in each group (with and without ShotBlocker).
As data collection tools; Personal and Applied Drug Information Form and Visual Analog Scale will be used. Personal Information Form will consist of 8 questions in total, 7 of which include the patients' introductory characteristics (age, gender, height, weight, fear of injection) and 1 question including the name of the drug. In addition to this form, Visual Analog Scale (VAS) is used to measure the pain perceived by the person. In this scale, the person can indicate his/her own pain by drawing a line, putting a dot or pointing between the part where there is no pain (zero) on one end of the ruler and the part where there is the most severe pain (10 cm) on the other end. The distance from the point where there is no pain to the point marked by the person is measured in centimeters and the value found indicates the person's pain intensity. In the VAS scale, 0-44 mm reflects mild pain, 45-74 mm reflects moderate pain and 75-100 mm reflects severe pain.
Research Application Procedure Step 1: Before starting the application, a preliminary interview will be conducted with practitioners who are not included in the study and who work as nurses in the emergency department. Information will be provided about the purpose of the study and the scale to be used. It will also be stated that these forms will be filled out by patients who received diclofenac sodium and metamizole sodium as IMI from the ventrogluteal region, used ShotBlocker during this period and met the research criteria.
Step 2: VAS will be applied to the patients immediately after the application. Step 3: VAS will also be applied to patients in the control group who received diclofenac sodium and metamizole sodium as IMI from the ventrogluteal region, did not use ShotBlocker during this period and met the research criteria.
Yağmur SÜRMELİ is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ShotBlocker will be applied to the experimental group.
Device: ShotBlocker
no intervention will be made
A randomized study investigating ShotBlocker in painkillers containing different active ingredients could not be found.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is used to measure the pain perceived by the person. In this scale, the individual can indicate their own pain by drawing a line, putting a dot, or pointing between the 10 cm (100 mm) section of the ruler where there is no pain (zero) on one end and the most severe pain on the other end. The distance from the point where there is no pain to the point marked by the individual is measured in centimeters and the value found indicates the individual\'s pain intensity. On the VAS scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm reflects severe pain.
Time frame: 12 week.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Yağmur SÜRMELİ