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Active (not recruiting) Not applicable NCT07550764

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

No applicable phase (e.g. observational)
Conditions: Lung Cancer (Diagnosis)

Sponsor: Ataturk University

trial.available_in: БГ
Overview
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.
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
Who can participate
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
Interventions
Device-assisted catheterization
DEVICE
Routine Catheterization
PROCEDURE
Locations 1
Turkey (1)
Ataturk University
Erzurum
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
17 Years
Healthy volunteers
No
Start date
01.11.2025
Completion date
01.06.2027
Registry ID
NCT07550764
Source
clinicaltrials.gov
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