Comparison of Two Methods of Immunization for Intramuscular Injections

This study is currently recruiting participants.
Verified November 2013 by Christiana Care Health Services
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01721083
First received: November 1, 2012
Last updated: November 25, 2013
Last verified: November 2013
  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.


Estimated Enrollment: 600
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721083

Locations
United States, Delaware
Christiana Care Health System Recruiting
Newark, Delaware, United States, 19716
Contact: Lynn E. Bayne, PhD, ARNP, NNP-BC    302-733-1583    LBayne@christianacare.org   
Contact: Ruth Mooney, PhD, RN    302-733-1578    RMooney@christianacare.org   
Principal Investigator: Lynn E Bayne, PhD, ARNP, NNP-BC         
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: November 25, 2013
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 April 22, 2014