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

Not Applicable

Completed

• Conditions: Phlebitis
• Interventions: Other: Cold application

• Registration Number: NCT05058053
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cold application group	Cold application	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.

Primary Outcome Measures

Name	Time	Method
the rate of development of phlebitis	24+2 hours	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.

Secondary Outcome Measures

Name	Time	Method
the grade of phlebitis	24+2 hours	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.

Trial Locations

Locations (1)

Gulhane Training and Research Hospital; 🇹🇷 Ankara, Turkey