NCT05892978

Brief Summary

Purpose: This study will be conducted on the effect of infrared light on PIVC procedure fear, procedure pain, and patient satisfaction in oncology patients receiving chemotherapy treatment. The investigators will implement the study during the insert on PIVC; the vascular imaging device with the infrared light group; the vascular access transillumination group; and the control group. Design: This is a prospective, randomized controlled experimental study.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable pain

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

June 17, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

May 29, 2023

Last Update Submit

June 6, 2023

Conditions

Keywords

Near-infrared lightTransilluminatorPeripheral intravenous cannulationVascular access

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (Pain)

    It is a one-dimensional scale used in the measurement of VAS pain. Among the one-dimensional scales used to determine the severity of pain in patients, it was determined that the VAS measures more sensitively and is more reliable. The scale consists of a 100 mm long horizontal line. On one end are the phrases "No Pain" and on the other end "Unbearable Pain" describing the most severe pain possible. The patient is asked to mark his pain on the scale. The length of the line from the starting point of the scale to the point marked by the patient is measured and recorded in mm. It includes minimum 0 point, maximum 100 points.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Visual Analog Scale (Fear)

    through study completion, an average of 1 year

Other Outcomes (1)

  • Patient satisfaction

    through study completion, an average of 1 year

Study Arms (3)

Vascular imaging device with the infrared light group

EXPERIMENTAL

The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data obtained on PIVC placement; vein visibility, the catheter number used in the procedure, the time to identify the appropriate vein, the successful PIVC placement time, the number of attempts for successful catheter placement, the vein in which the catheter was placed, the pain and fear levels before, during and after the procedure. These data will be recorded in the data form regarding the PIVC application. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

Other: Vascular imaging

Vascular access transillumination group

EXPERIMENTAL

The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse. The vein imaging device will be opened with transilluminator, the tourniquet will be connected, and the vein visibility will be re-evaluated by the operator. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data obtained on PIVC placement; the pain and fear levels before, during and after the procedure. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

Other: Vascular imaging

Control group

NO INTERVENTION

The patient's vital signs, skin color, and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse. Vein imaging will not be performed. No intervention will be carried out the tourniquet will be connected, and the vein visibility will be re-evaluated by the operator. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data will obtained on PIVC placement; the pain and fear levels before, during, and after the procedure. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

Interventions

Experimental group - Vascular imaging device with the infrared light group: Before PIVC, infrared light will be directed to the vein area and the procedure will be started after vein visibility is achieved. Experimental group - Vascular access transillumination group: Before PIVC, a transilluminator will be inserted to the vein area and the procedure will be started after vein visibility is achieved

Also known as: Vascular imaging device with the infrared light group, Vascular access transillumination group
Vascular access transillumination groupVascular imaging device with the infrared light group

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have undergone chemotherapy treatment and have received their first cure,
  • patients between the ages of 18 and 74,
  • patients who have not allergic to any substance,
  • patients who no peripheral vascular disease,
  • patients who does not have a chronic disease diagnosed other than cancer,
  • patients who does not use alcohol,
  • patients who non-smoker,
  • patients who not taking anticoagulant treatment,
  • patients who no signs of infiltration and phlebitis,
  • patients who have not acute trauma around the extremity, inflammation, ecchymosis, hematoma, scar tissue, edema, metal prosthesis, no paralysis,
  • patients who no visible deformity and thrombocytopenia in the examination,
  • patient who mastectomy has not been performed,
  • patients who do not have communication problems and whose mental level is suitable to participate in the research will be taken.

You may not qualify if:

  • patients who have under the age of 18 and over the age of 74,
  • patients who will receive chemotherapy for the first time,
  • patients who changing chemotherapy cure treatment,
  • patients who allergic to any substance,
  • patients who do not volunteer to participate in the study will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Ramer L, Hunt P, Ortega E, Knowlton J, Briggs R, Hirokawa S. Effect of Intravenous (IV) Assistive Device (VeinViewer) on IV Access Attempts, Procedural Time, and Patient and Nurse Satisfaction. J Pediatr Oncol Nurs. 2016 Jul;33(4):273-81. doi: 10.1177/1043454215600425. Epub 2015 Oct 28.

    PMID: 26510643BACKGROUND
  • Fink RM, Hjort E, Wenger B, Cook PF, Cunningham M, Orf A, Pare W, Zwink J. The impact of dry versus moist heat on peripheral IV catheter insertion in a hematology-oncology outpatient population. Oncol Nurs Forum. 2009 Jul;36(4):E198-204. doi: 10.1188/09.ONF.E198-E204.

    PMID: 19581223BACKGROUND
  • Aulagnier J, Hoc C, Mathieu E, Dreyfus JF, Fischler M, Le Guen M. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014 Aug;21(8):858-63. doi: 10.1111/acem.12437.

    PMID: 25176152BACKGROUND
  • Chiao FB, Resta-Flarer F, Lesser J, Ng J, Ganz A, Pino-Luey D, Bennett H, Perkins C Jr, Witek B. Vein visualization: patient characteristic factors and efficacy of a new infrared vein finder technology. Br J Anaesth. 2013 Jun;110(6):966-71. doi: 10.1093/bja/aet003. Epub 2013 Feb 5.

    PMID: 23384732BACKGROUND
  • Eren H, Caliskan N. Effect of a Vein Imaging Device and of Fist Clenching on Determination of an Appropriate Vein and on Catheter Placement Time in Patients Receiving Chemotherapy: A Randomized Controlled Trial. Cancer Nurs. 2022 Mar-Apr 01;45(2):105-112. doi: 10.1097/NCC.0000000000000931.

    PMID: 33654007BACKGROUND
  • Yilmaz H, Karacan Y, Macun S, Evrensel T. The effect of using vein visualization devices to facilitate peripheral intravenous cannulation on pain, fear, and patient satisfaction in adult oncology patients: a randomized controlled trial. Support Care Cancer. 2025 Nov 24;33(12):1123. doi: 10.1007/s00520-025-10187-4.

MeSH Terms

Conditions

PainIatrophobiaPatient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Yasemin Karacan, PhD

CONTACT

Türkkan Evrensel, Prof, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The intervention and measurements will carried out by the researcher (for hand manipulation standard) and the patients will discovered their own groups when intervention will applied to them. Because of the nature of the intervention, blinding will not be performed.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a prospective, randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD, Msc

Study Record Dates

First Submitted

May 29, 2023

First Posted

June 7, 2023

Study Start

June 17, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) doesn't share any other researchers. Only research team will see data on IPD. After the data collection phase is completed and turned into a publication, other researchers can access the publication.