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
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Procedural Pain Intensity Assessed by Visual Analog Scale (VAS)
研究概览
简要总结
This randomized controlled trial evaluated the effect of near-infrared (NIR) vein visualization-assisted peripheral intravenous catheterization on procedure-specific patient comfort, procedural pain and patient trust in nurses in adults with lung cancer receiving outpatient chemotherapy.
Patients receiving chemotherapy often develop progressive venous damage, which can make peripheral intravenous catheterization difficult. Failed attempts may increase pain and discomfort and may affect the patient's trust in the nurse.
The study used an explanatory sequential mixed-methods design (QUAN→qual). In the quantitative phase, 160 patients were randomized 1:1 to NIR-assisted catheterization or to standard catheterization based on visual inspection and palpation. In the qualitative phase, semi-structured individual interviews were conducted with 11 patients from the intervention group to explore their experiences with the NIR device.
The study was conducted at the Outpatient Chemotherapy Unit of Ataturk University Research Hospital, Erzurum, Turkey, as part of a doctoral thesis in Fundamentals of Nursing.
详细描述
BACKGROUND:
Peripheral intravenous catheterization (PIVC) is one of the most common invasive procedures in clinical practice. In patients receiving chemotherapy, repeated venous access and chemotherapy-related vascular damage can make catheterization difficult and can increase the number of attempts, pain and discomfort. Near-infrared (NIR) vein visualization devices project a real-time map of superficial veins onto the skin and may help the nurse select a suitable vein.
STUDY DESIGN:
Explanatory sequential mixed-methods design (QUAN→qual). The sequential nature of the design was established at the level of analysis and integration. Because patients in the outpatient unit could not easily be reached again after treatment, qualitative interviews were conducted during the same period as quantitative data collection; qualitative analysis and integration were performed after the quantitative analysis was completed. The trial is reported according to CONSORT 2025, the qualitative component according to COREQ and the mixed-methods integration according to GRAMMS.
Phase 1 (Quantitative): Single-centre, parallel-group (1:1), two-arm randomized controlled trial.
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 (Outcomes Assessor)
盲法说明
Masking of the practitioner nurse and the patient was not possible because the NIR device projects visible light onto the skin. Post-procedure outcomes (T2) were assessed by an independent researcher blinded to group allocation; patients were asked not to disclose their group. Some patients spontaneously disclosed the method used, so masking at T2 was partial. Procedure data (T1) were collected by an unblinded data collector using structured observation forms.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Histopathologically confirmed lung cancer (small cell or non-small cell)
- •Receiving active systemic chemotherapy (at least one cycle completed)
- •Indication for a peripheral intravenous catheter for chemotherapy administration
- •Able to speak and understand Turkish sufficiently to communicate
- •Read and signed the informed consent form
排除标准
- •Situations requiring emergency or life-saving catheterization
- •Presence of a central venous catheter (port, PICC or tunneled catheter)
- •Anatomical anomaly, amputation, post-mastectomy lymphedema or arteriovenous fistula in both upper extremities
- •Active local infection, dermatitis or impaired skin integrity at the planned catheterization site
- •Altered consciousness or disorientation
- •Mediastinal, supraclavicular or infraclavicular mass/lymphadenopathy that may affect upper extremity venous return
- •Withdrawal Criteria:
- •Withdrawal of consent at any stage
- •Need for an off-protocol intervention (decision for central access after failure at the third attempt)
- •Development of an acute clinical condition preventing completion of data collection
研究组 & 干预措施
Standard Catheterization Group
Participants (n=80 randomized) received peripheral intravenous catheterization using the unit's routine method of visual inspection and palpation, without any technological assistance (no NIR, ultrasound or transillumination). The same standard procedure and consumables as in the experimental group were used. Procedures were performed by the same trained unit nurses as in the experimental group (patient-level randomization). Maximum 3 attempts allowed.
干预措施: Routine Catheterization (Procedure)
NIR-Assisted Catheterization Group
Participants (n=80 randomized) received peripheral intravenous catheterization assisted by a near-infrared (NIR) vein visualization device. After tourniquet application and skin antisepsis, the device was held about 20-30 cm above the insertion site and the vein map projected onto the skin was used to select the vein; the device remained active during catheter advancement. Procedures were performed by the trained unit nurses (7 nurses in routine rotation, all with the same device training and a run-in period). Maximum 3 attempts allowed.
干预措施: Near-infrared vein visualization-assisted catheterization (Device)
结局指标
主要结局
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).
Procedure-Specific Patient Comfort Assessed by the Peripheral Intravenous Catheterization Comfort Scale (PIVCCS)
时间窗: Immediately after the catheterization procedure (within 30 minutes)
Procedure-specific patient comfort during peripheral intravenous catheterization, assessed with the 7-item Peripheral Intravenous Catheterization Comfort Scale (PIVCCS; Turkish version: PIKKO) rated on a 5-point Likert scale. Total scores range from 7 to 35, with higher scores indicating greater comfort. Assessed after the procedure (T2) by an assessor blinded to group allocation.
Patient Trust in Nurses Assessed by the Trust in Nurses Scale
时间窗: Immediately after the catheterization procedure (within 30 minutes)
Patient trust in nurses, assessed with the 5-item Trust in Nurses Scale (Radwin and Cabral; Turkish version by Yucel and Ay) rated on a 6-point Likert scale. Total scores range from 5 to 30, with higher scores indicating greater trust in nurses. Assessed after the procedure (T2) by an assessor blinded to group allocation.
次要结局
未报告次要终点
研究者
Burak YAVUZ
PhD Candidate, Registered Nurse
Ataturk University