Necessity of Aspiration in the Ventrogluteal Site

Not Applicable

• Conditions: Nursing; Injection Site
• Interventions: Other: The Necessity of Aspiration

• Registration Number: NCT04421599
• Lead Sponsor: Ege University

Brief Summary

H1: Aspiration is not necessary for IM injections applied from the ventrogluteal region.

H2: Aspiration procedure increases pain in IM injections applied from ventrogluteal region.

H3: The duration of the aspiration procedure on IM injections applied from the ventrogluteal region is effective on pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-14
• Status Verified: 2020-06
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Last Update Submitted: 2020-06-09
• Primary Completion: 2020-06-10
• Last Update Posted: 2020-06-11
• Study Completion: 2020-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 834

Inclusion Criteria

• Patient who came to the Emergency Service Care Unit for "Diclofenac Sodium" injection
• Have no vision and hearing problems,
• Who have no disease that may affect their perception of pain
• Who can evaluate the "Visual Analog Scale" correctly, scoring 5 points or less from the VAS,
• Body Mass Index is between 18.5-24.9 kg / m2,
• Who do not have any discomfort in the extremities that will prevent them from taking the desired position,
• No complications due to intramuscular injections such as abscess, infection, tissue necrosis and hematoma in the ventrogluteal region
• No nodules or masses in the area

Exclusion Criteria

• Patients who refuse the injection are excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group A	The Necessity of Aspiration	Experimental Group A who were administered intramuscular injection during which aspiration lasted for 5-10 seconds.
Experimental Group B	The Necessity of Aspiration	Experimental Group B who were not administered aspiration during IM injection.

Primary Outcome Measures

Name	Time	Method
Individual Introductory Information Form	15 minutes	The content of the study was explained to the patients coming to the emergency room. Written informed consents were obtained in line with the "Individual Introductory Information Form" of the patients.; Individual Introductory Information Form: This form includes questions such as the patient's application group, diagnosis, age, gender, height, weight, and blood intake during aspiration in intramuscular injection. It is completed within the first 10-15 minutes of contact with the patient.
Visual Analog Scale (VAS)	5 minutes	Intramuscular injection was performed in accordance with the application group assigned to the patients who filled the Individual Introductory Information Form. The patients were not told which group they belonged to.; A nurse who except the researcher who performed the application evaluated pain levels that patients feel during injection immediately after the intramuscular injection application, with a Visual Analog Scale. The minimum score that can be obtained from this scale is 0 and the maximum score is 10. A higher score indicates that the pain is more severe. This scale was applied in minutes 1-5 after intramuscular injection.

Trial Locations

Locations (1)

Ege University Hospital; 🇹🇷 İzmir, Turkey