THE EFFECT OF COLD APPLICATION ON THE DEVELOPMENT OF PHLEBITIS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE TREATMENT.

Study Overview
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Brief Summary
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This study, which has a quasi-experimental, prospective, and open-label randomized controlled design, was conducted to examine the effect of cold application on the development of phlebitis in patients receiving IV amiodarone infusion treatment. Study Hypotheses H0-1: There is no difference in the rate of development of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion. H0-2: There is no difference in the grade of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion. H0-3: There is no difference in the time of development of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.

Official Title
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INVESTIGATION OF THE EFFECT OF COLD APPLICATION ON THE DEVELOPMENT OF PHLEBITIS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE TREATMENT. A RANDOMIZED OPEN-LABEL TRIAL

Conditions
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Phlebitis

Intervention / Treatment
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* Other: Cold application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged over 18, who were planned to receive 300 mg amiodarone in 150 ccs of 5% dextrose + 900 mg amiodarone (maintenance) in 50 ccs of 5% Dextrose in 30 minutes (24 hour-infusion), Patients to whom PVC was placed in the upper extremity, and who did not develop phlebitis on the PVC site Exclusion Criteria: Cold allergy/sensitivity or circulatory disorders During the study, patients who had a change in the IV amiodarone treatment protocol, whose IV amiodarone treatment was terminated before 24 hours, whose IV amiodarone treatment protocol was started, but PVC had to be replaced for any reason during the 24-hour period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold application group<br>After starting amiodarone treatment, cold application was applied a total of 12 times on the infused PVC with cold gel packs for 15 minutes at 2-hour intervals. At all stages of the study, the researcher closely monitored the patients. During the treatment, the development of phlebitis after cold application during the 24-hour infusion was evaluated every 2 hours by the researcher using the Visual Infusion Phlebitis Scale and recorded. After starting the amiodarone infusion, the patients were observed for the development of phlebitis for 24 hours until the end of the procedure and for 2 hours after the end of the treatment. | Other: Cold application<br>* Cold application was applied a total of 12 times on the infused PVC with cold gel packs for 15 minutes at 2-hour intervals.<br>|
| No Intervention: Control group<br>the patients who were started on amiodarone infusion were observed for the development of phlebitis, receiving no intervention. During the treatment, phlebitis development was evaluated and recorded by the researcher using the Visual Infusion Phlebitis Scale every 2 hours during the 24-hour infusion. After starting the amiodarone infusion, the patients were observed for the development of phlebitis for 24 hours until the end of the procedure and for 2 hours after the end of the treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of development of phlebitis | the patients were observed for the development of phlebitis for 24 hours until the end of the procedure and for 2 hours after the end of the treatment.During the treatment, the development of phlebitis after cold application during the 24-hour infusion was evaluated every 2 hours by the researcher using the Visual Infusion Phlebitis Scale and recorded. | 24+2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the grade of phlebitis | the patients were observed for the development of phlebitis for 24 hours until the end of the procedure and for 2 hours after the end of the treatment.During the treatment, the development of phlebitis after cold application during the 24-hour infusion was evaluated every 2 hours by the researcher using the Visual Infusion Phlebitis Scale and recorded. | 24+2 hours |