Comparison of Two Methods of Immunization for Intramuscular Injections
|ClinicalTrials.gov Identifier: NCT01721083|
Recruitment Status : Completed
First Posted : November 5, 2012
Last Update Posted : July 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Consequences of Immunization Method||Procedure: Procedure: Z-track Procedure: Procedure: Bunch||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||511 participants|
|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|
|Study Start Date :||October 2012|
|Primary Completion Date :||July 2014|
|Study Completion Date :||July 2014|
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.
- Perceived pain [ Time Frame: 72 hours ]Subjects will be asked to rate perceived pain on scale of 0-10
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721083
|United States, Delaware|
|Christiana Care Health System|
|Newark, Delaware, United States, 19716|
|Principal Investigator:||Lynn E Bayne, PhD, ARNP, NNP-BC||Christiana Care Health Services|