Comparison of Two Methods of Immunization for Intramuscular Injections
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|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|
|Actual Primary Completion Date :||July 2014|
|Actual 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.
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
|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|