Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07550764

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Lung Cancer (Diagnosis) Disease Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25100, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Device

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Collaborators

  • Atatürk University Scientific Research Projects Coordination Unit

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.