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Reducing the Risk of Phlebitis From Peripheral Venous Catheter

Primary Purpose

Phlebitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous Catheter
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Phlebitis focused on measuring Phlebitis, Peripheric venous catheter, Nursıng Care, Palm fisting, Proximal massage

Eligibility Criteria

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

Inclusion Criteria: Patients who volunteered to participate in the study, Who are over 18 years old, Having no barriers to written and verbal communication in Turkish, IV treatment was applied during the hospitalization period and IV treatment was recently started, Patients with IV cannula in the upper extremity In the last six months before hospitalization, IV treatment was not applied, A maximum of 2 IV attempts should be made on a patient. Patients without chronic dermatological and/or vascular disease. Exclusion Criteria: Patients who did not volunteer to participate in the study, unconscious patients, IV attempts were made to the same patient more than 4 times in total, Patients with IV cannula in the lower extremity.

Sites / Locations

  • Kahramanmaras Sutcu Imam University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Proximal massage and fist clenching

Standard care for PVC

Arm Description

The experimental group of 36 patients underwent proximal massage and fist clenching after IV insertion. Proximal massage: For a total of 5 to 10 minutes, twice daily for 4 days, between 30 seconds- 1 minute in sessions of approximately 20 strokes, a light massage is administered utilizing the palm surfaces of the fingers. Fist Clenching : Under the researcher's supervision, participants in the activity known as palm fisting squeeze a soft palm ball 20 times in each of twice a day for four days, lasting between 30 seconds - 1 minute. The Peripheral Venous Catheter-Related Phlebitis Risk Scale, the Phlebitis Diagnostic Scale, and the Patient Information Form were employed right after following PVC (0. hour). The Phlebitis Diagnostic Scale was used for 96 hours to assess the patient's vascular access at the 24th, 48th, 72nd, and 96th hours.

The standard care group of 36 patients received typical nursing PVC care. Standard nurse PVC care: Only standard PVC care and follow-up were provided. It was carefully avoided that the patients would interact with one another or be in the same patient room. The Peripheral Venous Catheter-Related Phlebitis Risk Scale, the Phlebitis Diagnostic Scale, and the Patient Information Form were employed right after following PVC (0. hour). The Phlebitis Diagnostic Scale was used for 96 hours to assess the patient's vascular access at the 24th, 48th, 72nd, and 96th hours.

Outcomes

Primary Outcome Measures

Phlebitis Assessment Scale
The scale has five ratings as follows. Phlebitis with this scale: Grade 0: no symptoms, Grade 1: redness and/or pain at the catheter insertion site, Grade 2: redness, pain and/or edema at the catheter insertion site, Grade 3: redness, pain and/or edema at the catheter insertion site , red line, cable-like palpation of the vein, Grade 4: redness, pain and/or edema at the catheter insertion site, red line, cable-like palpation of the vein and if it is longer than 2.5 cm, it is considered as purulent discharge.

Secondary Outcome Measures

Peripheral Venous Catheter-Related Phlebitis Risk Scale
The scale consists of 14 items and three sub-dimensions. There are 3 items in the Individual Risk Factors sub-dimension, 6 items in the Chemical Risk Factors sub-dimension, and 5 items in the Mechanical Risk Factors sub-dimension. The scale has a 2-point rating and is designed to calculate the score for each item as "Yes=2 points" and "No=1 points". There is no reverse item in the scale. An increase in the score obtained from the scale indicates that the risk of phlebitis due to peripheral venous catheters increases.

Full Information

First Posted
January 8, 2023
Last Updated
February 3, 2023
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT05714137
Brief Title
Reducing the Risk of Phlebitis From Peripheral Venous Catheter
Official Title
Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

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
Nurses frequently use peripheral venous catheters in hospitals to provide medications and fluids for therapeutic and diagnostic purposes. Peripheral venous catheter use brought various problems, including phlebitis, infiltration, extravasation, ecchymosis, thrombophlebitis, and embolism, in addition to being a regularly utilized nursing practice. The literature used techniques like heat application, fist clenching, and proximal massage to lower the risk of thrombophlebitis and associated problems.
Detailed Description
Between October and November 2022, individuals who received orthopedic care at a state hospital and had peripheral venous catheters participated in the trial as a randomized controlled experimental study. The control group received routine nursing care, while the experimental group received proximal massage and palm fist exercises. The numbers used to identify the control and experimental groups were drawn at random from a table of random numbers, and each group had 36 patients. The researcher used the "Patient Information Form," "Plebitis Risk Scale Due to Peripheral Venous Catheter," and "Plebitis Diagnostic Scale" to collect data using in-person interviews and observational methods. The p value for statistical significance is p<0.05. Proximal massage: For a total of 5 to 10 minutes, twice daily for 4 days, between 30 seconds- 1 minute in sessions of approximately 20 strokes, a light massage is administered utilizing the palm surfaces of the fingers. Under the researcher's supervision, participants in the activity known as fist clenching squeeze a soft palm ball 20 times in each of twice a day for four days, lasting between 30 Seconds - 1 minute.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phlebitis
Keywords
Phlebitis, Peripheric venous catheter, Nursıng Care, Palm fisting, Proximal massage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proximal massage and fist clenching
Arm Type
Experimental
Arm Description
The experimental group of 36 patients underwent proximal massage and fist clenching after IV insertion. Proximal massage: For a total of 5 to 10 minutes, twice daily for 4 days, between 30 seconds- 1 minute in sessions of approximately 20 strokes, a light massage is administered utilizing the palm surfaces of the fingers. Fist Clenching : Under the researcher's supervision, participants in the activity known as palm fisting squeeze a soft palm ball 20 times in each of twice a day for four days, lasting between 30 seconds - 1 minute. The Peripheral Venous Catheter-Related Phlebitis Risk Scale, the Phlebitis Diagnostic Scale, and the Patient Information Form were employed right after following PVC (0. hour). The Phlebitis Diagnostic Scale was used for 96 hours to assess the patient's vascular access at the 24th, 48th, 72nd, and 96th hours.
Arm Title
Standard care for PVC
Arm Type
No Intervention
Arm Description
The standard care group of 36 patients received typical nursing PVC care. Standard nurse PVC care: Only standard PVC care and follow-up were provided. It was carefully avoided that the patients would interact with one another or be in the same patient room. The Peripheral Venous Catheter-Related Phlebitis Risk Scale, the Phlebitis Diagnostic Scale, and the Patient Information Form were employed right after following PVC (0. hour). The Phlebitis Diagnostic Scale was used for 96 hours to assess the patient's vascular access at the 24th, 48th, 72nd, and 96th hours.
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous Catheter
Intervention Description
Proximal massage: For a total of 5 to 10 minutes, twice daily for 4 days, between 30 seconds- 1 minute in sessions of approximately 20 strokes, a light massage is administered utilizing the palm surfaces of the fingers. Fist Clenching : Under the researcher's supervision, participants in the activity known as palm fisting squeeze a soft palm ball 20 times in each of 2 days a day for four days, lasting between 30 seconds - 1 minute.
Primary Outcome Measure Information:
Title
Phlebitis Assessment Scale
Description
The scale has five ratings as follows. Phlebitis with this scale: Grade 0: no symptoms, Grade 1: redness and/or pain at the catheter insertion site, Grade 2: redness, pain and/or edema at the catheter insertion site, Grade 3: redness, pain and/or edema at the catheter insertion site , red line, cable-like palpation of the vein, Grade 4: redness, pain and/or edema at the catheter insertion site, red line, cable-like palpation of the vein and if it is longer than 2.5 cm, it is considered as purulent discharge.
Time Frame
Within 96 hours, the development of PVC-related phlebitis will be evaluated.
Secondary Outcome Measure Information:
Title
Peripheral Venous Catheter-Related Phlebitis Risk Scale
Description
The scale consists of 14 items and three sub-dimensions. There are 3 items in the Individual Risk Factors sub-dimension, 6 items in the Chemical Risk Factors sub-dimension, and 5 items in the Mechanical Risk Factors sub-dimension. The scale has a 2-point rating and is designed to calculate the score for each item as "Yes=2 points" and "No=1 points". There is no reverse item in the scale. An increase in the score obtained from the scale indicates that the risk of phlebitis due to peripheral venous catheters increases.
Time Frame
Within the first 24 hours, the patient will be assessed using the Peripheral Venous Catheter-Associated Phlebitis Risk Scale.

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who volunteered to participate in the study, Who are over 18 years old, Having no barriers to written and verbal communication in Turkish, IV treatment was applied during the hospitalization period and IV treatment was recently started, Patients with IV cannula in the upper extremity In the last six months before hospitalization, IV treatment was not applied, A maximum of 2 IV attempts should be made on a patient. Patients without chronic dermatological and/or vascular disease. Exclusion Criteria: Patients who did not volunteer to participate in the study, unconscious patients, IV attempts were made to the same patient more than 4 times in total, Patients with IV cannula in the lower extremity.
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University
City
Karaman
State/Province
Kahramanmaraş
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31606488
Citation
Heng SY, Yap RT, Tie J, McGrouther DA. Peripheral Vein Thrombophlebitis in the Upper Extremity: A Systematic Review of a Frequent and Important Problem. Am J Med. 2020 Apr;133(4):473-484.e3. doi: 10.1016/j.amjmed.2019.08.054. Epub 2019 Oct 10.
Results Reference
background
PubMed Identifier
31547791
Citation
Lv L, Zhang J. The incidence and risk of infusion phlebitis with peripheral intravenous catheters: A meta-analysis. J Vasc Access. 2020 May;21(3):342-349. doi: 10.1177/1129729819877323. Epub 2019 Sep 23.
Results Reference
background
PubMed Identifier
19931816
Citation
Zingg W, Pittet D. Peripheral venous catheters: an under-evaluated problem. Int J Antimicrob Agents. 2009;34 Suppl 4:S38-42. doi: 10.1016/S0924-8579(09)70565-5.
Results Reference
background
Links:
URL
http://innovationalpublishers.com/Content/uploads/PDF/1049008542_04_IJNS_07-JM-2022-08.pdf
Description
sample article

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Reducing the Risk of Phlebitis From Peripheral Venous Catheter

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