Comparison of Two Methods of Immunization for Intramuscular Injections

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: July 2014

Detailed Description

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.

Interventions

  • Procedure: Procedure: Z-track
    • Subject received immunization by z-track
  • Procedure: Procedure: Bunch
    • Subject receives immunization by bunch method.

Arms, Groups and Cohorts

  • Experimental: Z-Track immunization
    • Subject receives Intramuscular injection by z-track method during flu vaccination given by employee health Registered Nurse into deltoid muscle.
  • Active Comparator: Bunch immunization
    • Subject receives Intramuscular injection by bunch method during flu vaccination given by employee health Registered Nurse into deltoid muscle.

Clinical Trial Outcome Measures

Primary Measures

  • Perceived pain
    • Time Frame: 72 hours
    • Subjects will be asked to rate perceived pain on scale of 0-10

Secondary Measures

  • Medication leakage
    • Time Frame: 72 hours
    • Any medication leakage from either arm within 72 hours
  • Redness at injection site
    • Time Frame: 72 hours
    • Redness, as determined by naive observer at injection site immediately and up to 72 hours after study.

Participating in This Clinical Trial

Inclusion Criteria

  • healthy adults without latex allergy over 18 years of age Exclusion Criteria:

  • latex allergy – illness – 18 years or less

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Christiana Care Health Services
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lynn E Bayne, PhD, ARNP, NNP-BC, Principal Investigator, Christiana Care Health Services

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