Phlebitis Care and Warm Wet Application

NCT05226312 | Completed

• 1 other identifier: OrduSBF
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Phlebitis is an inflammation of the tunica intima layer of the vein. Intravenous administration of drugs with high pH and osmolarity via a peripheral intravenous catheter damages the vascular structure, causing the drug to leak out of the vessel and cause phlebitis. Planning the care of the area where phlebitis occurs is the responsibility of the nurses. When phlebitis symptoms are seen, the infusion is terminated, the treatment is continued from another area, the extremity is elevated, and warm application is started. However, studies in the literature on what, how many degrees, how many times a day, and how long the warm application should be made are limited. Therefore, this planned thesis study was designed as a randomized controlled experimental study to determine the effect of warm wet application in the care of peripheral intravenous catheter-related phlebitis. The study will be carried out in Ordu University Training and Research Hospital oncology, hematology, palliative, infection, and obstetrics services. The population of the study will be the patients with phlebitis symptoms, and the sample will be 70 patients determined by G power analysis. Volunteer patients with phlebitis symptoms after drug infusion with a peripheral intravenous catheter will be included in the study. Data will be obtained using the "Patient Information Form", "Phlebitis Follow-up Form" and "Phlebitis Care Schedule". The patients included in the study will be divided into experimental and control groups by the randomization method. A warm wet compress will be applied to the phlebitis developing area of the patients in the experimental group, three times a day for three days. No intervention will be made in the control group. The data will be evaluated by using the SPSS 22.0 package program at a significance level of p\<0.05 with a 95% confidence interval, and by Student-t or Mann-Whitney-U test in independent groups according to their suitability for normal distribution. It is thought that the results of the study will reduce the symptoms of phlebitis, guide nurses towards care and increase patient satisfaction.

Conditions

Pain; Phlebitis; Nursing Caries

Keywords

Pain; quality of health care; Peripheral Intravenous Catheter

Outcome Measures

Primary Outcomes (3)

• The effect of warm wet application on pain in the care of peripheral intravenous catheter-related phlebitis

  The degree of pain before and after the application will be evaluated with the Numeric Rating Scale (NRS). Numeric Rating Scale (NRS) takes values between 0 and 10 points. As the pain score increases, the pain level also increases. Patients included in the study will be evaluated for approximately 69 days until April 10, 2022.

  approximately 69 days until 10 April 2022

• The effect of hot wet application on redness in the care of peripheral intravenous catheter-related phlebitis.

  The degree of redness will be determined with Opsite Flexigirit before and after application. After the warm wet application, the degree of redness will be determined again and the effectiveness of the warm wet application will be evaluated. Patients included in the study will be evaluated for approximately 69 days until April 10, 2022.

  approximately 69 days until 10 April 2022

• The effect of warm wet application on edema in the care of peripheral intravenous catheter-related phlebitis

  Before and after the warm wet application, the extent of edema will be determined with Opsite Flexigirit. When the is evaluated with Opsite Flexigirit, the width of edema increases as the surface width increases. Patients included in the study will be evaluated for approximately 69 days until April 10, 2022.

  approximately 69 days until 10 April 2022

Secondary Outcomes (1)

• The effect of the warm wet application on the degree of phlebitis in the care of peripheral intravenous catheter-related phlebitis.

  approximately 69 days until 10 April 2022

Study Arms (2)

Local Warm Compress

EXPERIMENTAL

They are gauze covers brought to a certain temperature (temperature varies between 26-34°C or 79-93°F in warm applications) as a compress material, or wraps and covers that can be reheated.

Other: Local Warm Compress

Not Local Warm Compress

NO INTERVENTION

No warm wet application will be made to this group. It will be tracked for only 3 days.

Interventions

Local Warm Compress OTHER

The warm application will be made by the researcher for 15 minutes three times a day according to the local warm application process steps.

Local Warm Compress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and over,
• Taking the medication with a peripheral intravenous catheter,
• Those with phlebitis symptoms and phlebitis symptoms are regularly monitored,
• No application other than extremity elevation after phlebitis was detected,
• Those who are conscious and able to respond

You may not qualify if:

• Neutropenia,
• Heat allergy,
• Peripheral vascular disease,
• Having a dialysis catheter in the application area,
• Receiving anticoagulant therapy,
• Those who have an open wound, scar tissue, metal prosthesis in the area where phlebitis develops,
• Unconscious and unresponsive patients discharged,
• Patients wishing to withdraw from the study

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Fatma Aksoy

Ordu, 52000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Phlebitis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Officials

• Fatma Aksoy, RN

  Ordu University

  PRINCIPAL INVESTIGATOR

• Sule Bıyık Bayram, PhD

  Karadeniz Teknik University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Randomize Control experimental study

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: February 7, 2022
• Study Start: February 8, 2022
• Primary Completion: March 10, 2022
• Study Completion: April 10, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)