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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