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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05714137
Other study ID # 4819
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date November 30, 2022

Study information

Verified date February 2023
Source Kahramanmaras Sutcu Imam University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date November 30, 2022
Est. primary completion date October 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous Catheter
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.

Locations

Country Name City State
Turkey Kahramanmaras Sutcu Imam University Karaman Kahramanmaras

Sponsors (1)

Lead Sponsor Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Within 96 hours, the development of PVC-related phlebitis will be evaluated.
Secondary 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. Within the first 24 hours, the patient will be assessed using the Peripheral Venous Catheter-Associated Phlebitis Risk Scale.
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