- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07820956
Ice Application for Oxacillin-Related Phlebitis and Pain
Effect of Ice Application on Reducing Peripheral Vascular Phlebitis and Pain After Oxacillin Injection: A Randomized Single-Blind Controlled Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Fengyuan, Taiwan
- Feng Yuan Hospital, Ministry of Health and Welfare
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adults aged 20 to 60 years. Conscious and able to participate in the study. Intravenous injection site located on either hand. Receiving a single antibiotic medication during the study. Eligible regardless of sex or medical diagnosis.
Exclusion Criteria:
Dementia. Psychiatric disorders. Skin rash at the study site. Purpura. Pregnancy. Current oral corticosteroid use. Hemodialysis. Administration of a second medication or an injection containing two or more medications during the study.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Ice Application Group
Participants assigned to this group received ice application around the peripheral intravenous catheter site before intravenous oxacillin administration.
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Ice was applied around the peripheral intravenous catheter site before intravenous oxacillin administration.
The intervention was intended to reduce pain associated with oxacillin administration and the occurrence of peripheral intravenous phlebitis.
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Active Comparator: Room-Temperature Water-Bag Control Group
Participants assigned to this group received a room-temperature water-bag application around the peripheral intravenous catheter site before intravenous oxacillin administration.
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A room-temperature water bag was applied around the peripheral intravenous catheter site before intravenous oxacillin administration as the control condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity After Intravenous Oxacillin Administration
Time Frame: Up to 72 hours after intravenous oxacillin administration
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Pain intensity associated with intravenous oxacillin administration was assessed repeatedly after oxacillin administration across nine 8-hour intervals during the 72-hour observation period.
Higher pain scores indicated greater pain intensity.
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Up to 72 hours after intravenous oxacillin administration
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Pain Intensity After Intravenous Oxacillin Administration
Time Frame: From 1 to 72 hours after initiation of the study intervention, assessed at 1-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, and 65-72 hours.
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Pain intensity associated with intravenous oxacillin administration was assessed using a numerical rating scale, with higher scores indicating greater pain.
Pain was assessed repeatedly after oxacillin administration across nine 8-hour intervals during the 72-hour observation period.
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From 1 to 72 hours after initiation of the study intervention, assessed at 1-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, and 65-72 hours.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FYH-IRB-111004
- 111004 (Other Identifier: Feng Yuan Hospital, Ministry of Health and Welfare)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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