PhlebitisNCT05714137

Reducing the Risk of Phlebitis From Peripheral Venous Catheter

A study testing Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous Catheter in people with Phlebitis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Phlebitis
What is being tested?: Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous Catheter
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Oct 2022to 30 Nov 2022
Phase: Interventional
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Kahramanmaras Sutcu Imam University
Karaman, Kahramanmaraş

Other trials in Turkey (Türkiye)

About this study

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

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.

Conditions: Phlebitis
Being tested: Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous Catheter
Keywords: Phlebitis, Peripheric venous catheter, Nursıng Care, Palm fisting, Proximal massage
Medical subject headings: Phlebitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous CatheterBehavioural
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.

Study groups in NCT05714137
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202230 Nov 2022

First posted6 Feb 2023
Study start1 Oct 2022
Primary completion15 Oct 2022
Study completion30 Nov 2022

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: Parallel groups
Model description: two groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05714137
Sponsor's protocol ID: 4819
Status last verified: Feb 2023
First submitted: 8 Jan 2023
Last updated: 8 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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
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.
PubMed 38366675

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of Proximal Massage and Palm-to-Fist Tapping on Reducing the Risk of Phlebitis
Phlebitis, Catheter Complications
Not yet recruitingObservational study
Implementing an Evidence-based, Standardized Care Bundle Targeting Register Nurses and Anaesthesiologists, to Enhance Patient Safety and Quality of Intravascular Access Devices Care Management - The Safe-IVADs Project. A Longitudinell Implementation Intervention With an Embedded Process Evaluation.
Phlebitis, Thrombophlebitis
Recruiting
Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter Survival
Peripheral Intravenous Vein Catheter Phlebitis, Intravenous Infection
Not yet recruitingPhase 2
Comparing of Sesame Oil, Nitroglycerin Ointment, and Aloe Vera Gel
Cancer, Chemotherapy
Not yet recruiting
Prevention of Phlebitis, Infiltration and Extravasation With Infusion Monitoring System
Extravasation, Intensive Care Units (ICUs)

All Phlebitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous Catheter
ClinicalTrials.gov ID: NCT05714137
Acronym / sponsor ID: 4819
Conditions: Phlebitis
Keywords: Phlebitis, Peripheric venous catheter, Nursıng Care, Palm fisting, Proximal massage
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
Study start: 1 Oct 2022 (actual)
Primary completion: 15 Oct 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 6 Feb 2023 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: two groups

Arm	Type	Receives
Proximal massage and fist clenching	Experimental	Behavioral: Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous CatheterThe 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.
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (3 listed)

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.

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
Evaluation of the Effect of Proximal Massage and Fist Clenching in Reducing the Risk of Phlebitis From Peripheral Venous CatheterProximal 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.	Behavioural	Proximal massage and fist clenching

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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.
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.
Background: PubMed 19931816Zingg 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.
Derived from this study: PubMed 38366675Tosun 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.
Individual participant dataSharing planned: No

Related trials for Phlebitis

Recruiting
Evaluation of Proximal Massage and Palm-to-Fist Tapping on Reducing the Risk of Phlebitis
Phlebitis, Catheter Complications
Not yet recruitingObservational study
Implementing an Evidence-based, Standardized Care Bundle Targeting Register Nurses and Anaesthesiologists, to Enhance Patient Safety and Quality of Intravascular Access Devices Care Management - The Safe-IVADs Project. A Longitudinell Implementation Intervention With an Embedded Process Evaluation.
Phlebitis, Thrombophlebitis
Recruiting
Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter Survival
Peripheral Intravenous Vein Catheter Phlebitis, Intravenous Infection
Not yet recruitingPhase 2
Comparing of Sesame Oil, Nitroglycerin Ointment, and Aloe Vera Gel
Cancer, Chemotherapy
Not yet recruiting
Prevention of Phlebitis, Infiltration and Extravasation With Infusion Monitoring System
Extravasation, Intensive Care Units (ICUs)

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 3 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: finished, as of the sponsor's last update on 8 Feb 2023. 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 Turkey (Türkiye). 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phlebitis Assessment Scale (time frame: Within 96 hours, the development of PVC-related phlebitis will be evaluated.). 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 NCT05714137, 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 8 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.