Comparison of Two Methods of Immunization for Intramuscular Injections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01721083
First received: November 1, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Consequences of Immunization Method
Procedure: Procedure: Z-track
Procedure: Procedure: Bunch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparison of Two Methods of Immunization for Intramuscular Injections

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Perceived pain [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Subjects will be asked to rate perceived pain on scale of 0-10


Secondary Outcome Measures:
  • Medication leakage [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Any medication leakage from either arm within 72 hours

  • Redness at injection site [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Redness, as determined by naive observer at injection site immediately and up to 72 hours after study.


Enrollment: 511
Study Start Date: October 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Z-Track immunization
Subject receives Intramuscular injection by z-track method during flu vaccination given by employee health Registered Nurse into deltoid muscle.
Procedure: Procedure: Z-track
Subject received immunization by z-track
Active Comparator: Bunch immunization
Subject receives Intramuscular injection by bunch method during flu vaccination given by employee health Registered Nurse into deltoid muscle.
Procedure: Procedure: Bunch
Subject receives immunization by bunch method.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adults without latex allergy over 18 years of age

Exclusion Criteria:

  • latex allergy
  • illness
  • 18 years or less
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721083

Locations
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19716
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Lynn E Bayne, PhD, ARNP, NNP-BC Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01721083     History of Changes
Other Study ID Numbers: DDD# 602056
Study First Received: November 1, 2012
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Christiana Care Health Services:
intramuscular injection
bunch
z-track

ClinicalTrials.gov processed this record on July 24, 2014