Necessity of Aspiration in the Ventrogluteal Site

NCT ID: NCT04421599

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

834 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2020-06-20

Brief Summary

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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

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Conditions

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Nursing Injection Site

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental Group A

Experimental Group A who were administered intramuscular injection during which aspiration lasted for 5-10 seconds.

Group Type EXPERIMENTAL

The Necessity of Aspiration

Intervention Type OTHER

The patients who met the inclusion criteria and agreed to participate in the study were assigned to the Experimental Group A who were administered IM injection during which aspiration lasted for 5-10 seconds, to the Control Group who were administered IM injection during which aspiration lasted for 1-2 seconds, and to the Experimental Group B who were not administered IM injection according to the stratified block randomization list. The same "Intramuscular Injection Application Protocol" was applied while all the injections were administered.

Control Group

Control Group who were administered intramuscular injection during which aspiration lasted for 1-2 seconds.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Group B

Experimental Group B who were not administered aspiration during IM injection.

Group Type EXPERIMENTAL

The Necessity of Aspiration

Intervention Type OTHER

The patients who met the inclusion criteria and agreed to participate in the study were assigned to the Experimental Group A who were administered IM injection during which aspiration lasted for 5-10 seconds, to the Control Group who were administered IM injection during which aspiration lasted for 1-2 seconds, and to the Experimental Group B who were not administered IM injection according to the stratified block randomization list. The same "Intramuscular Injection Application Protocol" was applied while all the injections were administered.

Interventions

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The Necessity of Aspiration

The patients who met the inclusion criteria and agreed to participate in the study were assigned to the Experimental Group A who were administered IM injection during which aspiration lasted for 5-10 seconds, to the Control Group who were administered IM injection during which aspiration lasted for 1-2 seconds, and to the Experimental Group B who were not administered IM injection according to the stratified block randomization list. The same "Intramuscular Injection Application Protocol" was applied while all the injections were administered.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Leyla BARAN

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ege University Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Beyea SC, Nicoll LH. Administration of medications via the intramuscular route: an integrative review of the literature and research-based protocol for the procedure. Appl Nurs Res. 1995 Feb;8(1):23-33. doi: 10.1016/s0897-1897(95)80279-7.

Reference Type BACKGROUND
PMID: 7695353 (View on PubMed)

Baran L, Gunes U, Donmez H. Investigation of the Necessity of Aspiration During the Intramuscular Injection Administered in the Ventrogluteal Site and Its Effect on Pain: A Randomized Controlled Trial. Clin Nurs Res. 2023 May;32(4):821-829. doi: 10.1177/10547738221136470. Epub 2022 Dec 20.

Reference Type DERIVED
PMID: 36540016 (View on PubMed)

Other Identifiers

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0000-0001-7881-8556

Identifier Type: -

Identifier Source: org_study_id

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