PhlebitisNCT07703618
Evaluation of Proximal Massage and Palm-to-Fist Tapping on Reducing the Risk of Phlebitis
A study testing Estandard peripheral venous catheter care protocol and Efecto del masaje proximal y del golpeteo de la palma al puño. in people with Phlebitis and Catheter Complications, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Phlebitis, Catheter Complications
- What is being tested?
- Estandard peripheral venous catheter care protocol and Efecto del masaje proximal y del golpeteo de la palma al puño.
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 1 siteColombia
- Study dates
- 3 Jun 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Universitario San Ignacio
Bogotá, Bogota D.C.
Sandra Valderrama, Dra., +57 (601) 5946161 ext. 6932, slvalderrama@husi.org.co
About this study
Official title: 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.
Read the 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.
- Conditions
- Phlebitis, Catheter Complications
- Being tested
- Estandard peripheral venous catheter care protocol, Efecto del masaje proximal y del golpeteo de la palma al puño.
- Keywords
- Proximal Massage, Palm-to-Fist Tapping, Risk of Phlebitis
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estandard peripheral venous catheter care protocolOther
control group will receive the standard peripheral venous catheter care protocol implemented
Efecto del masaje proximal y del golpeteo de la palma al puño.Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Efecto del masaje proximal y del golpeteo de la palma al puño. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 assigned to the intervention group will receive standardized instruction from the study investigators and will be encouraged
Measured: Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start3 Jun 2025
- Primary completion15 Dec 2025
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PhlebitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 273 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ángel García, Dr, Principal investigator, Hospital Universitario San Ignacio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703618
- Sponsor's protocol ID
- 2024/293
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
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 31606488Cihan 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.
PubMed 31547791
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Proximal Massage and Palm-to-Fist Tapping on Reducing the Risk of Phlebitis Associated With Peripheral Venous Catheter Insertion
- ClinicalTrials.gov ID
- NCT07703618
- Acronym / sponsor ID
- 2024/293
- Conditions
- Phlebitis, Catheter Complications
- Keywords
- Proximal Massage, Palm-to-Fist Tapping, Risk of Phlebitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 273 participants (estimated)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Estandard peripheral venous catheter care protocol | Placebo comparator | Other: Estandard peripheral venous catheter care protocolParticipants assigned to the control group will receive the standard peripheral venous catheter care protocol implemented at Hospital Universitario San Ignacio |
| Effect of proximal massage and palm-to-fist tapping | Experimental | Behavioral: Efecto del masaje proximal y del golpeteo de la palma al puño.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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estandard peripheral venous catheter care protocolcontrol group will receive the standard peripheral venous catheter care protocol implemented | Other | Estandard peripheral venous catheter care protocol |
| 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 | Behavioural | Effect of proximal massage and palm-to-fist tapping |
Primary outcome
Incidence of phlebitis during the observation period
Time frame: Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
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
1 secondary outcome
Time to first episode of phlebitis, maximum phlebitis severity during follow-up and evaluate factors associated with the development of phlebitis
Time frame: Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 31606488Heng 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.
- BackgroundCihan Erdoğ an B, Zehra GB. Nursing initiatives in peripheral intravenous catheter re- lated flebit and preventıon. Gazi J Heal Sci 2020;5:30-36
- BackgroundOzturk 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: PubMed 31547791Lv 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ángel García, Dr principal investigator
Hospital Universitario San Ignacio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estandard peripheral venous catheter care protocol and Efecto del masaje proximal y del golpeteo de la palma al puño. in people with Phlebitis and Catheter Complications, run by Hospital Universitario San Ignacio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Valderrama, Dra (+57(601) 594616 ext. 6932, svalderrama.med@javeriana.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of phlebitis during the observation period (time frame: Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07703618, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.