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Phlebitis Care and Warm Wet Application

Primary Purpose

Pain, Phlebitis, Nursing Caries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Local Warm Compress
Sponsored by
T.C. ORDU ÜNİVERSİTESİ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Pain, quality of health care, Peripheral Intravenous Catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Fatma Aksoy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Local Warm Compress

Not Local Warm Compress

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

The effect of the warm wet application on the degree of phlebitis in the care of peripheral intravenous catheter-related phlebitis.
The degree of phlebitis before and after the application will be determined according to the phlebitis scale. After the warm wet application, the degree of phlebitis will be determined again and the effectiveness of the warm wet application will be evaluated. The phlebitis scale consists of 5 degrees and as the number of degrees increases, the rate of phlebitis increases. Patients included in the study will be evaluated for approximately 69 days until April 10, 2022.

Full Information

First Posted
October 28, 2021
Last Updated
September 8, 2022
Sponsor
T.C. ORDU ÜNİVERSİTESİ
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1. Study Identification

Unique Protocol Identification Number
NCT05226312
Brief Title
Phlebitis Care and Warm Wet Application
Official Title
The Effect of Warm Wet Application in the Care of Peripheral Intravenous Catheter-related Phlebitis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
April 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Peripheral intravenous (PIV) therapy is the process of injecting fluid directly into the patient's vein. In cases where fluid and electrolyte balance cannot be achieved in patients who cannot be fed orally, in the administration of chemotherapy, antibiotics, and other intravenously administered drugs, intravenous therapy is frequently used in patients followed at the intensive care level, and fluids are given directly into the bloodstream. Although peripheral IV therapy has many benefits on the patient, complications such as phlebitis, infiltration, extravasation, thrombosis, cellulitis, and bloodstream infection may occur. The occurrence of these complications is related to inadequate catheter care, length and diameter of the catheter, length of stay in the vein, the substance it is produced, the patient's vascular structure and position, the type and flow rate of the given fluid, the length of stay in the hospital, and the individual characteristics of the patient. Peripheral intravenous catheter complications may develop during catheterization or during infusion or may occur 24-96 hours after catheter removal. When these complications are encountered, the duration of the hospital stay of the patient is prolonged, and as a result, mortality and morbidity rates increase. The incidence of PIV catheter complications in our country is close to 50%. Among the complications, the most common and the most important complication is phlebitis. While the incidence of phlebitis is between 24.3% and 31.8% according to national studies, this rate is between 2.63% and 44% in international studies. Studies have reported that the incidence of phlebitis is higher in individuals receiving chemotherapy. Because chemotherapy treatments are usually administered by the PIV route. The irritant, vesicant, non-vesicant properties of chemotherapy drugs, high pH and osmolarity levels, and repeated cure treatments damage peripheral veins. In addition, antibiotics, hypertonic solutions, blood, and nutritional products, and analgesics are risk factors for the development of phlebitis. Phlebitis is defined as the inflammation of the tunica intima layer of the vein. Phlebitis occurs in three ways: mechanical, chemical, and bacterial. Mechanical phlebitis; It is seen for reasons such as the individual characteristics of the patient, the catheter insertion site, the catheter type, and number, the material used in the catheter fixation, the length of time the catheter stays in the vein, the treatment time, the skill of the person inserting the catheter, the determination of the appropriate vein, the fluid flow rate, the use of infusion pumps, and the number of drugs given. Chemical phlebitis; It is seen when irritating drugs are given intravenously in a liquid with a density of 600 mOsm/lt or the pH of the fluids is less than 5 and greater than 9. Bacterial phlebitis is caused by factors such as cleaning the area with antiseptic, the frequency of changing the infusion set from the material on which the catheter is fixed, and the care of the catheter site. Symptoms of phlebitis are redness, erythema, pain, edema, palpable stiffness along the vein (venous cord), prominence of the venous line, tenderness, discharge, and warmth. The catheter site should be followed up with the "Visual Infusion Phlebitis Diagnostic Scale" in terms of these symptoms. However, in a study conducted by Arpa and Cengiz, it was found that nurses did not know the scale and had a lack of knowledge. Therefore, not following the catheter site and not recognizing the symptoms increase the incidence of phlebitis. When one of the symptoms of phlebitis is observed, the degree of phlebitis should be defined according to the scale and appropriate nursing interventions should be planned. In the care of the patient with phlebitis, the infusion should be terminated, the catheter should be removed, the extremity should be elevated, and a new catheter should be inserted to continue treatment from another site. The area where phlebitis develops should not be used for a new catheterization for at least 48 hours. Symptoms such as redness, pain, swelling, and length of venous cord-shaped hardening in the area where phlebitis develops should be followed according to the visual phlebitis scale. In addition, it is stated in the literature that local warm application can be applied to the area with phlebitis symptoms. However, there is no clear information in the literature regarding when to start local warm application, its duration, and frequency. Local warm application is frequently used by nurses to provide dilatation of blood vessels, to reduce inflammation by increasing oxygen circulation in hypoxic conditions, and for the non-pharmacological treatment of pain and tenderness. Hot/cold applications can be applied in two ways, wet or dry. The web application provides a moist environment in the area, increases blood flow to the area, carries nutrients, leukocytes, and antibodies, and increases the rate of wound healing. Wet application is more effective than dry application as the heat spreads rapidly to the deep tissues. However, changing the compresses frequently is important for the effectiveness of the application, as it causes evaporation with vasodilation and cooling of the skin. Thermophore, aquathermic pad, hot or cold gel, hot water bath, ice accumulators, electric heating pad, and compresses are used for hot or cold applications. In the research to be conducted, a warm wet compress will be used. Compresses are used to apply local heat. Compress temperature is brought to the range of 26-34°C (79-93°F) for warm application. Compresses can be prepared in a wide variety of sizes and allowed to apply a certain temperature to the body area. In the literature, it is stated in the literature that in the case of phlebitis, applying warm wet compresses to the affected area can be used to accelerate the blood flow and to reduce sensitivity and pain with the effect of tissue healing in the area. However, studies on this subject are limited. In a study conducted by Annisa et al. (2017) in 36 individuals aged 1 month to 17 years who developed phlebitis, one group was treated with warm water (n=16) and the other group (n=16) with 0.9% NaCl 3 to 4 times a day. Compress was applied for 20 minutes. When the phlebitis area was followed 24 and 48 hours later, it was stated that the degree of phlebitis decreased statistically significantly. In a study conducted by Hidayah et al. (2017) on 40 individuals aged 17-44 years, it was reported that there was a statistically significant difference in vessel diameter before and after warm wet application and reduced phlebitis. In the study of Gauttan and Vati (2016) with 60 individuals, it was found that wet heat and cold application for 20 minutes every two hours is equally effective and can be used for the treatment of phlebitis. The Infusion Nurses Association (IHD) stated that it is very important to reduce the incidence of phlebitis to 5% and below, to prevent its occurrence, to be recognized early and to take necessary precautions, or to care about it occurs. Nurses working in clinics such as oncology, hematology, and palliative where phlebitis is common should have sufficient knowledge of phlebitis prevention, care, treatment, and practice. Nursing care provided by following current developments and using evidence-based nursing practices will decrease the incidence of phlebitis and increase the quality of care. In the literature, it is stated that warm application can be used in the care of phlebitis. However, it is not specified what the application will be done with, the temperature and how many times a day it will be done. Therefore, the aim of this study is to determine the effect of warm wet application in the care of peripheral venous catheter-related phlebitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Phlebitis, Nursing Caries
Keywords
Pain, quality of health care, Peripheral Intravenous Catheter

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomize Control experimental study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local Warm Compress
Arm Type
Experimental
Arm Description
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.
Arm Title
Not Local Warm Compress
Arm Type
No Intervention
Arm Description
No warm wet application will be made to this group. It will be tracked for only 3 days.
Intervention Type
Other
Intervention Name(s)
Local Warm Compress
Intervention Description
The warm application will be made by the researcher for 15 minutes three times a day according to the local warm application process steps.
Primary Outcome Measure Information:
Title
The effect of warm wet application on pain in the care of peripheral intravenous catheter-related phlebitis
Description
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.
Time Frame
approximately 69 days until 10 April 2022
Title
The effect of hot wet application on redness in the care of peripheral intravenous catheter-related phlebitis.
Description
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.
Time Frame
approximately 69 days until 10 April 2022
Title
The effect of warm wet application on edema in the care of peripheral intravenous catheter-related phlebitis
Description
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.
Time Frame
approximately 69 days until 10 April 2022
Secondary Outcome Measure Information:
Title
The effect of the warm wet application on the degree of phlebitis in the care of peripheral intravenous catheter-related phlebitis.
Description
The degree of phlebitis before and after the application will be determined according to the phlebitis scale. After the warm wet application, the degree of phlebitis will be determined again and the effectiveness of the warm wet application will be evaluated. The phlebitis scale consists of 5 degrees and as the number of degrees increases, the rate of phlebitis increases. Patients included in the study will be evaluated for approximately 69 days until April 10, 2022.
Time Frame
approximately 69 days until 10 April 2022

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Aksoy, RN
Organizational Affiliation
T.C. ORDU ÜNİVERSİTESİ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sule Bıyık Bayram, PhD
Organizational Affiliation
Karadeniz Teknik University
Official's Role
Study Director
Facility Information:
Facility Name
Fatma Aksoy
City
Ordu
ZIP/Postal Code
52000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Phlebitis Care and Warm Wet Application

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