Comparison of Two Methods of Immunization for Intramuscular Injections

NCT ID: NCT01721083

Last Updated: 2014-07-16

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-07-31

Brief Summary

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This study is designed to compare two different styles of intramuscular injection (Bunch versus Z-Track)during flu vaccination with the following outcome measures as basis for comparison: perceive pain, redness, medication leakage, other complications within 72 hours in healthy adult volunteer subjects.

Detailed Description

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This study is designed to compare two different styles of intramuscular injection (Bunch versus Z-Track)during flu vaccination with the following outcome measures as basis for comparison: perceive pain, redness, medication leakage, other complications within 72 hours in healthy adult volunteer subjects.

Conditions

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Consequences of Immunization Method

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Z-Track immunization

Subject receives Intramuscular injection by z-track method during flu vaccination given by employee health Registered Nurse into deltoid muscle.

Group Type EXPERIMENTAL

Procedure: Z-track

Intervention Type PROCEDURE

Subject received immunization by z-track

Bunch immunization

Subject receives Intramuscular injection by bunch method during flu vaccination given by employee health Registered Nurse into deltoid muscle.

Group Type ACTIVE_COMPARATOR

Procedure: Bunch

Intervention Type PROCEDURE

Subject receives immunization by bunch method.

Interventions

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Procedure: Z-track

Subject received immunization by z-track

Intervention Type PROCEDURE

Procedure: Bunch

Subject receives immunization by bunch method.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* healthy adults without latex allergy over 18 years of age

Exclusion Criteria

* latex allergy
* illness
* 18 years or less
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lynn E Bayne, PhD, ARNP, NNP-BC

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

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Christiana Care Health System

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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DDD# 602056

Identifier Type: -

Identifier Source: org_study_id

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