Evaluation of Proximal Massage and Palm-to-Fist Tapping on Reducing the Risk of Phlebitis

Evaluation of the Effect of Proximal Massage and Palm-to-Fist Tapping on Reducing the Risk of Phlebitis Associated With Peripheral Venous Catheter Insertion

Phlebitis is a clinical condition that develops as a complication of peripheral venous catheter use. Peripheral venous catheterization is a common clinical procedure performed in hospitalized patients, as it provides vascular access for the administration of medications, blood products, and contrast media for diagnostic imaging studies. The pathophysiology of phlebitis involves inflammation of the vascular intima, leading to luminal narrowing and impaired blood flow. These changes are clinically manifested by local signs of inflammation, including erythema, edema, and pain, which have been objectively assessed using several validated clinical assessment scales.

Study Overview

• Status: Recruiting
• Conditions: Phlebitis; Catheter Complications
• Intervention / Treatment: Other: Estandard peripheral venous catheter care protocol; Behavioral: Efecto del masaje proximal y del golpeteo de la palma al puño.

Detailed Description

Peripheral venous catheter insertion is a common clinical procedure performed in a substantial proportion of hospitalized patients. It is estimated that between 58.7% and 86.7% of hospitalized patients require a peripheral venous catheter during their hospital stay, and, ideally, catheter dwell time should not exceed six days. Indications for peripheral venous catheterization are diverse and include hemodynamic monitoring, intravenous administration of fluids and medications, blood transfusions, and the administration of contrast media for diagnostic imaging procedures.

Despite being a routine and relatively simple procedure, complications associated with peripheral venous catheter use continue to represent an important public health concern because they are associated with prolonged hospital stays, delayed patient discharge, and increased healthcare costs. The most common complications include phlebitis, infiltration, ecchymosis, extravasation, and embolism. These complications may occur while the catheter remains in place or even up to 96 hours after catheter removal. Therefore, given the widespread use of peripheral venous catheters and the potentially deleterious consequences of these complications, appropriate catheter management and care are essential to reduce their incidence.

Phlebitis is defined as inflammation of the venous intima and is clinically characterized by local inflammatory signs, including erythema, edema, and pain. Reported incidence rates range from 2% to 80%, depending largely on the control of modifiable risk factors. Three major categories of risk factors have been associated with the development of phlebitis. The first comprises patient-related factors, including age, sex, and pre-existing medical conditions. The second includes chemical factors, primarily related to the dose and osmolarity of intravenously administered medications. The third encompasses mechanical factors, such as catheter size, insertion site, and catheter material.

Several types of phlebitis have been described, each associated with different risk factors. Mechanical phlebitis is related to catheter size and material, inadequate catheter stabilization that facilitates catheter movement and subsequent irritation of the vascular wall, and catheter placement near a joint. Bacterial phlebitis develops as a consequence of poor aseptic technique or prolonged catheter dwell time. Finally, chemical phlebitis is associated with the characteristics of the cannulated vein and the type of infused solution, particularly highly acidic or alkaline solutions.

• Study Type: Interventional
• Enrollment (Estimated): 273
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra Valderrama, Dra; Phone Number: 6932 +57(601) 594616; Email: svalderrama.med@javeriana.edu.co

Study Locations

• Colombia
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia
      • Recruiting
      • Hospital Universitario San Ignacio
      • Contact: Sandra Valderrama, Dra.; Phone Number: 6932 +57 (601) 5946161; Email: slvalderrama@husi.org.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible participants will be adults aged 18 years or older who have had a PIVC inserted into an upper extremity within the previous 24 hours and are expected to require peripheral intravenous access for at least 48 hours.

Exclusion Criteria:

• Patients will be excluded if they have impaired consciousness, critical illness precluding participation in the intervention, physical limitations preventing performance of the prescribed exercises, anatomical or functional abnormalities of the catheterized upper extremity, or if adequate clinical follow-up cannot be ensured.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Estandard peripheral venous catheter care protocol; Participants assigned to the control group will receive the standard peripheral venous catheter care protocol implemented at Hospital Universitario San Ignacio	Other: Estandard peripheral venous catheter care protocol; control group will receive the standard peripheral venous catheter care protocol implemented
Experimental: Effect of proximal massage and palm-to-fist tapping; The intervention will consist of two non-pharmacological components. Following hand hygiene, participants will receive gentle massage using the palmar surface of the fingers over an area located approximately 2-3 cm proximal to the peripheral intravenous catheter insertion site. Each session will last approximately 2-3 minutes and will be performed three times daily for up to four consecutive days or until catheter removal, whichever occurs first.	Behavioral: Efecto del masaje proximal y del golpeteo de la palma al puño.; Following hand hygiene, participants will receive gentle massage using the palmar surface of the fingers over an area located approximately 2-3 cm proximal to the peripheral intravenous catheter insertion site. Each session will last approximately 2-3 minutes and will be performed three times daily for up to four consecutive days or until catheter removal, whichever occurs first

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of phlebitis during the observation period	To evaluate the effect of proximal massage and palm-to-fist tapping exercises on reducing the risk of peripheral venous catheter-related phlebitis during the first 96 hours after catheter insertion	Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first episode of phlebitis, maximum phlebitis severity during follow-up and evaluate factors associated with the development of phlebitis	Participants assigned to the intervention group will receive standardized instruction from the study investigators and will be encouraged	Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.

Collaborators and Investigators

• Sponsor: Hospital Universitario San Ignacio
• Investigators: Principal Investigator: Ángel García, Dr, Hospital Universitario San Ignacio

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.
• Cihan Erdoğ an B, Zehra GB. Nursing initiatives in peripheral intravenous catheter re- lated flebit and preventıon. Gazi J Heal Sci 2020;5:30-36
• Ozturk D, Erdogan BC, Dogan N, Kiziltepe K, Baykara ZG. Phlebitis related to peripheric intravenous catheter: A point prevalence study. J Ankara Univ Fac Med 2021;74:310-316
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2025
• Primary Completion (Actual): December 15, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Proximal Massage; Palm-to-Fist Tapping; Risk of Phlebitis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Vasculitis; Phlebitis
• Other Study ID Numbers: 2024/293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data that underlie the results reported in articles published from this study, after de-identification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No