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

NCT07550764 | Active Not Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/596
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial investigates the effect of Near-Infrared (NIR) vein visualization technology on patient comfort, procedural pain, and nurse-patient trust during peripheral intravenous catheterization in lung cancer patients receiving chemotherapy. Lung cancer patients undergoing chemotherapy frequently experience progressive venous damage, making peripheral intravenous catheterization increasingly difficult. Failed catheterization attempts lead to increased pain, anxiety, reduced treatment adherence, and compromised nurse-patient trust. This study uses an explanatory sequential mixed-methods design (QUAN→qual). In the quantitative phase, 160 patients (80 intervention, 80 control) will be randomized. The intervention group will receive NIR-assisted catheterization, while the control group will receive standard palpation-based catheterization. Primary outcomes include patient comfort, pain levels (VAS), and nurse-patient trust scores. Secondary outcomes include first-attempt success rate, procedure duration, and complication rates. In the qualitative phase, 15-20 patients from the intervention group will be interviewed using a phenomenological approach to explore their experiences with NIR technology. The study is conducted at Ataturk University Research Hospital Chemotherapy Unit in Erzurum, Turkey.

Conditions

Lung Cancer (Diagnosis)

Keywords

nursing; near infrared; lung cancer

Outcome Measures

Primary Outcomes (3)

• Patient Comfort Score Assessed by Patient Comfort Scale (PCS)

  Patient comfort level during peripheral intravenous catheterization assessed using the Patient Comfort Scale (PCS). Scores range from 0 to 10, with higher scores indicating greater comfort. Assessed before (T0) and immediately after the catheterization procedure (T2).

  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)

• Nurse-Patient Trust Score Assessed by the Nurse-Patient Trust Scale (NPTS)

  Nurse-patient trust level assessed using the Nurse-Patient Trust Scale (NPTS). Higher scores indicate greater trust in the nurse-patient relationship. Measured before (T0) and immediately after the catheterization procedure (T2).

  Immediately after the catheterization procedure (within 30 minutes)

Study Arms (2)

NIR-Assisted Catheterization Group

EXPERIMENTAL

Participants (n=80) receive peripheral intravenous catheterization using a Near-Infrared (NIR) vein visualization device. The NIR device uses 700-950 nm wavelength light to visualize veins up to 15 mm deep in real-time, projecting a vein map onto the skin surface. The procedure is performed by the same trained nurse. Maximum 3 attempts allowed.

Device: Device-assisted catheterization

Standard Catheterization Group

ACTIVE COMPARATOR

Participants (n=80) receive peripheral intravenous catheterization using the standard palpation and visual inspection method without any technological assistance. The procedure is performed by the same trained nurse as in the experimental group to minimize bias. Maximum 3 attempts allowed.

Procedure: Routine Catheterization

Interventions

Device-assisted catheterization DEVICE

A Near-Infrared (NIR) vein visualization device is used to assist peripheral intravenous catheterization. The device emits 700-950 nm wavelength near-infrared light, which is absorbed more by hemoglobin in the blood than surrounding tissue. The reflected light is captured and processed to create a real-time vein map projected onto the patient's skin surface, visualizing veins up to 15 mm deep. This allows the nurse to identify optimal vein location, branching patterns, valve positions, and blood flow before needle insertion, thereby improving first-attempt success and reducing procedural pain.

Also known as: Device

NIR-Assisted Catheterization Group

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

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with Lung Cancer.
• Being over 17 years old.
• no communication barriers
• needing a peripheral catheter

You may not qualify if:

• Communication problem
• loss of limb
• having a central venous catheter

Sponsors & Collaborators

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

Study Sites (1)

Ataturk University

Erzurum, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Interventions

Equipment and Supplies

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: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 24, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)