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CompletedNCT05714137Updated Feb 8, 2023

Reducing the Risk of Phlebitis From Peripheral Venous Catheter

An interventional study of Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous Catheter in Phlebitis, sponsored by Kahramanmaras Sutcu Imam University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2022, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Phlebitis

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Keywords

  • Phlebitis
  • Peripheric venous catheter
  • Nursıng Care
  • Palm fisting
  • Proximal massage
03

In context

Phlebitis

45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.

This study's enrollment of 36 is below the median of 134 across 38 interventional studies indexed under Phlebitis.

Browse Phlebitis studies →

Lead sponsor

Kahramanmaras Sutcu Imam University is the lead sponsor of 198 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • 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.

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

  • 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.

Interventions

  • BehavioralEvaluation 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 96 hours, the development of PVC-related phlebitis will be evaluated.

Secondary outcomes

  1. 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.

    Time frame: Within the first 24 hours, the patient will be assessed using the Peripheral Venous Catheter-Associated Phlebitis Risk Scale.

07

Study locations

1 site
  • Kahramanmaras Sutcu Imam University
    Karaman, Kahramanmaraş, Turkey
08

References and documents

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. PubMed 31606488 ↗
  • 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. PubMed 31547791 ↗
  • 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. PubMed 19931816 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2022 to primary completion in Oct 2022, 0 months.

Of 21 interventional studies with no phase under Phlebitis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2023
First posted
Feb 6, 2023
StartActual
Oct 1, 2022
Primary completionActual
Oct 15, 2022
CompletionActual
Nov 30, 2022
Last update
Feb 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05714137
Responsible party
SERAP GÜNGÖR (Principal Investigator, Kahramanmaras Sutcu Imam University) — Principal investigator
First posted
Feb 6, 2023
Start date
Oct 1, 2022
Primary completion
Oct 15, 2022
Completion
Nov 30, 2022
Last update
Feb 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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