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

NCT07703618 | Recruiting

• 1 other identifier: 2024/293
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Phlebitis; Catheter Complications

Keywords

Proximal Massage; Palm-to-Fist Tapping; Risk of Phlebitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to first episode of phlebitis, maximum phlebitis severity during follow-up and evaluate factors associated with the development of phlebitis

  Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.

Study Arms (2)

Estandard peripheral venous catheter care protocol

PLACEBO COMPARATOR

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

Effect of proximal massage and palm-to-fist tapping

EXPERIMENTAL

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.

Interventions

Estandard peripheral venous catheter care protocol OTHER

control group will receive the standard peripheral venous catheter care protocol implemented

Estandard peripheral venous catheter care protocol

Efecto del masaje proximal y del golpeteo de la palma al puño. BEHAVIORAL

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

Effect of proximal massage and palm-to-fist tapping

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. 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.

You may not qualify if:

• a.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.

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, Bogota D.C., Colombia

RECRUITING

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: 31606488 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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: 31547791 BACKGROUND

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Officials

• Ángel García, Dr

  Hospital Universitario San Ignacio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Valderrama, Dra

CONTACT

+57(601) 594616; svalderrama.med@javeriana.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study will be conducted as an open-label, randomized controlled trial among hospitalized adult patients at Hospital Universitario San Ignacio, Bogotá, Colombia. The study has been designed in accordance with the CONSORT 2010 Statement for randomized controlled trials, and the Template for Intervention Description and Replication Checklist
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention or the control group using a computer-generated randomization sequence created through the REDCap randomization module. The allocation sequence will be generated by an independent investigator who will not participate in participant recruitment, intervention delivery, outcome assessment, or statistical analysis. Allocation concealment will be ensured by the REDCap system, which will reveal treatment assignment only after participant eligibility has been confirmed and enrollment completed. Owing to the nature of the intervention, blinding of participants and investigators delivering the intervention will not be feasible. However, outcome assessments will be performed by trained evaluators who will remain blinded to treatment allocation.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: June 3, 2025
• Primary Completion: December 15, 2025
• Study Completion: July 31, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)