Effect of Infrared-Assisted Intravenous Catheterization on Patient Comfort and Nurse-Patient Trust in Lung Cancer Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Patient Comfort Score Assessed by Patient Comfort Scale (PCS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being diagnosed with Lung Cancer.
- •Being over 17 years old.
- •no communication barriers
- •needing a peripheral catheter
排除标准
- •Communication problem
- •loss of limb
- •having a central venous catheter
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Routine Catheterization (Procedure)
结局指标
主要结局
Patient Comfort Score Assessed by Patient Comfort Scale (PCS)
时间窗: 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)
时间窗: 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)
时间窗: 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).
次要结局
未报告次要终点
研究者
Burak YAVUZ
Principal Investigator
Ataturk University