Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624761
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Effect of Shotblocker in Reducing Intramuscular Injection Pain in Adult Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Determination of the Effect of Shotblocker in Reducing Intramuscular Injection Pain in Adult Patients A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 questions it aims to answer are as follows
Is there a difference between the pain score averages between the intervention group and the control group after ShotBlocker Participants Participants in both groups are individuals who applied to the emergency department and received IM injections according to the doctor39s order If there is a comparison group Researchers will make a comparison with the control group
Is there a difference between the pain score averages between the intervention group and the control group after ShotBlocker Participants Participants in both groups are individuals who applied to the emergency department and received IM injections according to the doctor39s order If there is a comparison group Researchers will make a comparison with the control group
Detailed Description:
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 001 an effect size of 1583 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 hisher 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 persons 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
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 hisher 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 persons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None