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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
November 1, 2012
November 5, 2012
July 16, 2014
October 2012
July 2014   (Final data collection date for primary outcome measure)
Perceived pain [ Time Frame: 72 hours ]
Subjects will be asked to rate perceived pain on scale of 0-10
Same as current
Complete list of historical versions of study NCT01721083 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Comparison of Two Methods of Immunization for Intramuscular Injections
Comparison of Two Methods of Immunization for Intramuscular Injections
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Consequences of Immunization Method
  • Procedure: Procedure: Z-track
    Subject received immunization by z-track
  • Procedure: Procedure: Bunch
    Subject receives immunization by bunch method.
  • Experimental: Z-Track immunization
    Subject receives Intramuscular injection by z-track method during flu vaccination given by employee health Registered Nurse into deltoid muscle.
    Intervention: Procedure: Procedure: 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.
    Intervention: Procedure: Procedure: Bunch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
511
July 2014
July 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy adults without latex allergy over 18 years of age

Exclusion Criteria:

  • latex allergy
  • illness
  • 18 years or less
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01721083
DDD# 602056
No
Not Provided
Not Provided
Christiana Care Health Services
Christiana Care Health Services
Not Provided
Principal Investigator: Lynn E Bayne, PhD, ARNP, NNP-BC Christiana Care Health Services
Christiana Care Health Services
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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