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

April 22, 2026 updated by: Burak YAVUZ, Ataturk University

Effect of Infrared-Assisted Intravenous Catheterization on Patient Comfort and Nurse-Patient Trust in Lung Cancer Patients: A Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

Peripheral intravenous catheterization (PIVC) is one of the most common invasive procedures in clinical settings. First-attempt success rates range from 65% to 87% in adults, but can drop to as low as 40% in cancer patients with chemotherapy-induced vascular damage. Near-Infrared (NIR) vein visualization technology uses 700-950 nm wavelength light to create real-time maps of veins up to 15 mm deep, potentially improving catheterization outcomes.

STUDY DESIGN:

This is a pragmatic, explanatory sequential mixed-methods study with two phases:

Phase 1 (Quantitative): Randomized controlled trial with parallel group design.

  • Intervention group (n=80): PIVC using NIR vein visualization device
  • Control group (n=80): PIVC using standard palpation and inspection method
  • Both groups: Maximum 3 attempts allowed per patient
  • Same trained nurse performs catheterization for both groups to minimize bias

Phase 2 (Qualitative): Phenomenological approach

  • 15-20 patients selected from intervention group using maximum variation sampling
  • Semi-structured in-depth interviews (30-45 minutes)
  • Audio recorded and transcribed
  • Thematic analysis with two independent coders (Cohen's Kappa > 0.80)

SAMPLE SIZE CALCULATION:

Calculated using G*Power 3.1.9.7 with alpha=0.05, power=0.80, medium effect size (d=0.50). Minimum 64 patients per group, inflated to 80 per group (total 160) accounting for 20% attrition.

DATA COLLECTION TIMEPOINTS:

T0 (Baseline): Patient demographics and trust scale pre-test T1 (During procedure): Number of attempts, procedure duration, complications T2 (Post-procedure): VAS pain scores and trust scale post-test

STATISTICAL ANALYSIS:

Quantitative: Independent samples t-test, Mann-Whitney U test, Chi-square test, ANCOVA for trust scale scores, Cohen's d for effect sizes (SPSS 28.0) Qualitative: Thematic analysis, joint display tables for mixed-methods integration

HYPOTHESES:

H1: NIR-assisted PIVC significantly increases patient comfort compared to standard method H2: NIR-assisted PIVC significantly reduces procedural pain H3: NIR technology positively affects nurse-patient trust relationship H4: Patients experience NIR technology as safe, comfortable, and preferable

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIR-Assisted Catheterization Group
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
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.
Other Names:
  • Device
Active Comparator: Standard Catheterization Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Comfort Score Assessed by Patient Comfort Scale (PCS)
Time Frame: Immediately after the catheterization procedure (within 30 minutes)
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)
Time Frame: Immediately after the catheterization procedure (within 30 minutes)
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)
Time Frame: Immediately after the catheterization procedure (within 30 minutes)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Collaborators

Atatürk University Scientific Research Projects Coordination Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 12, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/596

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

waiting for the work to be completed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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