We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Two Methods of Immunization for Intramuscular Injections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01721083
First Posted: November 5, 2012
Last Update Posted: July 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christiana Care Health Services
  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 (Participant, 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 ]
    Subjects will be asked to rate perceived pain on scale of 0-10


Secondary Outcome 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.


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01721083     History of Changes
Other Study ID Numbers: DDD# 602056
First Submitted: November 1, 2012
First Posted: November 5, 2012
Last Update Posted: July 16, 2014
Last Verified: July 2014

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

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs