Effect of Infrared-Assisted Intravenous Catheterization on Patient Comfort and Nurse-Patient Trust in Lung Cancer Patients

NCT07550764 | Completed

• 2 other identifiers: B.30.2.ATA.0.01.00/596TDK-2025-16156
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluated the effect of near-infrared (NIR) vein visualization-assisted peripheral intravenous catheterization on procedure-specific patient comfort, procedural pain and patient trust in nurses in adults with lung cancer receiving outpatient chemotherapy. Patients receiving chemotherapy often develop progressive venous damage, which can make peripheral intravenous catheterization difficult. Failed attempts may increase pain and discomfort and may affect the patient's trust in the nurse. The study used an explanatory sequential mixed-methods design (QUAN→qual). In the quantitative phase, 160 patients were randomized 1:1 to NIR-assisted catheterization or to standard catheterization based on visual inspection and palpation. In the qualitative phase, semi-structured individual interviews were conducted with 11 patients from the intervention group to explore their experiences with the NIR device. The study was conducted at the Outpatient Chemotherapy Unit of Ataturk University Research Hospital, Erzurum, Turkey, as part of a doctoral thesis in Fundamentals of Nursing.

Conditions

Lung Cancer (Diagnosis)

Keywords

nursing; near infrared; lung cancer; peripheral intravenous catheterization; vein visualization; patient comfort; trust; chemotherapy

Outcome Measures

Primary Outcomes (3)

• Procedure-Specific Patient Comfort Assessed by the Peripheral Intravenous Catheterization Comfort Scale (PIVCCS)

  Procedure-specific patient comfort during peripheral intravenous catheterization, assessed with the 7-item Peripheral Intravenous Catheterization Comfort Scale (PIVCCS; Turkish version: PIKKO) rated on a 5-point Likert scale. Total scores range from 7 to 35, with higher scores indicating greater comfort. Assessed after the procedure (T2) by an assessor blinded to group allocation.

  Immediately after the catheterization procedure (within 30 minutes)

• Procedural Pain Intensity Assessed by Visual Analog Scale (VAS)

  Procedural pain intensity during peripheral intravenous catheterization assessed using the Visual Analog Scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain). Measured immediately after the catheterization procedure (T2).

  Immediately after the catheterization procedure (within 30 minutes)

• Patient Trust in Nurses Assessed by the Trust in Nurses Scale

  Patient trust in nurses, assessed with the 5-item Trust in Nurses Scale (Radwin and Cabral; Turkish version by Yucel and Ay) rated on a 6-point Likert scale. Total scores range from 5 to 30, with higher scores indicating greater trust in nurses. Assessed after the procedure (T2) by an assessor blinded to group allocation.

  Immediately after the catheterization procedure (within 30 minutes)

Study Arms (2)

NIR-Assisted Catheterization Group

EXPERIMENTAL

Participants (n=80 randomized) received peripheral intravenous catheterization assisted by a near-infrared (NIR) vein visualization device. After tourniquet application and skin antisepsis, the device was held about 20-30 cm above the insertion site and the vein map projected onto the skin was used to select the vein; the device remained active during catheter advancement. Procedures were performed by the trained unit nurses (7 nurses in routine rotation, all with the same device training and a run-in period). Maximum 3 attempts allowed.

Device: Near-infrared vein visualization-assisted catheterization

Standard Catheterization Group

ACTIVE COMPARATOR

Participants (n=80 randomized) received peripheral intravenous catheterization using the unit's routine method of visual inspection and palpation, without any technological assistance (no NIR, ultrasound or transillumination). The same standard procedure and consumables as in the experimental group were used. Procedures were performed by the same trained unit nurses as in the experimental group (patient-level randomization). Maximum 3 attempts allowed.

Procedure: Routine Catheterization

Interventions

Routine Catheterization PROCEDURE

Standard peripheral intravenous catheterization performed using conventional palpation and visual inspection technique without any technological assistance. The nurse identifies the vein by touch and visual assessment, applies a tourniquet, and inserts the catheter based on clinical experience. This represents the current standard of care in most clinical settings.

Standard Catheterization Group

Near-infrared vein visualization-assisted catheterization DEVICE

A near-infrared (NIR) vein visualization device was used to assist peripheral intravenous catheterization. The device uses near-infrared light (700-950 nm), which is absorbed more by hemoglobin than by the surrounding tissue, and projects a real-time map of superficial veins onto the skin. After tourniquet application and skin antisepsis, the device was positioned about 20-30 cm above the insertion site; the nurse used the projected image to assess the course, branching and diameter of the veins and to select the most suitable vein. The device was kept active during catheter advancement.

Also known as: NIR vein finder

NIR-Assisted Catheterization Group

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older
• Histopathologically confirmed lung cancer (small cell or non-small cell)
• Receiving active systemic chemotherapy (at least one cycle completed)
• Indication for a peripheral intravenous catheter for chemotherapy administration
• Able to speak and understand Turkish sufficiently to communicate
• Read and signed the informed consent form

You may not qualify if:

• Situations requiring emergency or life-saving catheterization
• Presence of a central venous catheter (port, PICC or tunneled catheter)
• Anatomical anomaly, amputation, post-mastectomy lymphedema or arteriovenous fistula in both upper extremities
• Active local infection, dermatitis or impaired skin integrity at the planned catheterization site
• Altered consciousness or disorientation
• Mediastinal, supraclavicular or infraclavicular mass/lymphadenopathy that may affect upper extremity venous return
• Withdrawal Criteria:
• Withdrawal of consent at any stage
• Need for an off-protocol intervention (decision for central access after failure at the third attempt)
• Development of an acute clinical condition preventing completion of data collection

Sponsors & Collaborators

• Ataturk University: lead
• Atatürk University Scientific Research Projects Coordination Unit: collaborator

Study Sites (1)

Ataturk University Research Hospital

Erzurum, Erzurum, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking of the practitioner nurse and the patient was not possible because the NIR device projects visible light onto the skin. Post-procedure outcomes (T2) were assessed by an independent researcher blinded to group allocation; patients were asked not to disclose their group. Some patients spontaneously disclosed the method used, so masking at T2 was partial. Procedure data (T1) were collected by an unblinded data collector using structured observation forms.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Registered Nurse

Model Details: Explanatory sequential mixed-methods study. Phase 1: single-centre, parallel-group (1:1) randomized controlled trial comparing NIR-assisted and standard peripheral intravenous catheterization. Phase 2: qualitative interviews with 11 patients from the NIR group.

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 24, 2026
• Study Start: April 1, 2026
• Primary Completion: August 31, 2026
• Study Completion: August 31, 2026
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)