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PainNCT05226312

Phlebitis Care and Warm Wet Application

A study testing Local Warm Compress in people with Pain and Phlebitis, run by Ordu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Phlebitis, Nursing Caries
What is being tested?
Local Warm Compress
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
8 Feb 2022to 10 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Fatma Aksoy

    Ordu, 52000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Warm Wet Application in the Care of Peripheral Intravenous Catheter-related Phlebitis.

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.

Read the 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.

Being tested
Local Warm Compress
Keywords
Pain, quality of health care, Peripheral Intravenous Catheter
Medical subject headings
Pain, Phlebitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local Warm CompressOther

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

Study groups in NCT05226312
Study groupRoleWhat they receive
Local Warm CompressExperimentalThey 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.
Receives: Other: Local Warm Compress
Not Local Warm CompressNo interventionNo warm wet application will be made to this group. It will be tracked for only 3 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: approximately 69 days until 10 April 2022

  2. 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.

    Measured: approximately 69 days until 10 April 2022

  3. 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.

    Measured: approximately 69 days until 10 April 2022

Secondary outcomes (1)
  1. 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.

    Measured: approximately 69 days until 10 April 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start8 Feb 2022
  3. Primary completion10 Mar 2022
  4. Study completion10 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomize Control experimental study
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05226312
Sponsor's protocol ID
OrduSBF
Status last verified
Sep 2022
First submitted
28 Oct 2021
Last updated
9 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Local Warm Compress in people with Pain and Phlebitis, run by Ordu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of warm wet application on pain in the care of peripheral intravenous catheter-related phlebitis (time frame: approximately 69 days until 10 April 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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