Effect of Infrared-Assisted Intravenous Catheterization on Patient Comfort and Nurse-Patient Trust in Lung Cancer Patients: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ataturk University
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Patient Comfort Score Assessed by Patient Comfort Scale (PCS)
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Device-assisted catheterization (Device)
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.
Intervention: Routine Catheterization (Procedure)
Outcomes
Primary Outcomes
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).
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).
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Burak YAVUZ
Principal Investigator
Ataturk University