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| Name | Class |
|---|---|
| Atatürk University Scientific Research Projects Coordination Unit | UNKNOWN |
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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.
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.
Phase 2 (Qualitative): Phenomenological approach
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University | Erzurum | 25100 | Turkey (Türkiye) |
waiting for the work to be completed
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| 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. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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