- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05714137
Reducing the Risk of Phlebitis From Peripheral Venous Catheter
Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous Catheter
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kahramanmaraş
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Karaman, Kahramanmaraş, Turkey
- Kahramanmaras Sutcu Imam University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Standard care for PVC
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.
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|
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EXPERIMENTAL: Proximal massage and fist clenching
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phlebitis Assessment Scale
Time Frame: Within 96 hours, the development of PVC-related phlebitis will be evaluated.
|
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.
|
Within 96 hours, the development of PVC-related phlebitis will be evaluated.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peripheral Venous Catheter-Related Phlebitis Risk Scale
Time Frame: Within the first 24 hours, the patient will be assessed using the Peripheral Venous Catheter-Associated 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.
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Within the first 24 hours, the patient will be assessed using the Peripheral Venous Catheter-Associated Phlebitis Risk Scale.
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4819
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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