NCT05714137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

14 days

First QC Date

January 8, 2023

Last Update Submit

February 3, 2023

Conditions

Keywords

PhlebitisPeripheric venous catheterNursıng CarePalm fistingProximal massage

Outcome Measures

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.

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

Secondary Outcomes (1)

  • Peripheral Venous Catheter-Related Phlebitis Risk Scale

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

Study Arms (2)

Proximal massage and fist clenching

EXPERIMENTAL

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

Standard care for PVC

NO INTERVENTION

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

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.

Proximal massage and fist clenching

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Karaman, Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 31606488BACKGROUND
  • 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.

    PMID: 31547791BACKGROUND
  • 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.

    PMID: 19931816BACKGROUND
  • Tosun B, Gungor S, Agkale E, Andi S. Evaluation of the effect of proximal massage and palm fisting in reducing the risk of peripheral venous catheter-related phlebitis: randomized control study. Eur J Cardiovasc Nurs. 2024 Sep 5;23(6):644-651. doi: 10.1093/eurjcn/zvae024.

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesVasculitis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: two groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2023

First Posted

February 6, 2023

Study Start

October 1, 2022

Primary Completion

October 15, 2022

Study Completion

November 30, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations