The Effect of Infrared Light Use on Pain, Fear, and Patient Satisfaction During Peripheral Intravenous Catheter (PIVC) Procedure in Oncology Patients Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 主要终点
- Visual Analog Scale (Pain)
研究概览
简要总结
Purpose: This study will be conducted on the effect of infrared light on PIVC procedure fear, procedure pain, and patient satisfaction in oncology patients receiving chemotherapy treatment. The investigators will implement the study during the insert on PIVC; the vascular imaging device with the infrared light group; the vascular access transillumination group; and the control group.
Design: This is a prospective, randomized controlled experimental study.
详细描述
The population of the research will be cancer patients who applied to Bursa Uludag University Medical Faculty Hospital Oncology unit between June 2023 and July 2025. The population of the study will consist of patients who applied to the Chemotherapy Unit in Bursa Uludağ University Health Research and Application Center Hospital Oncology Polyclinic for outpatient treatment. It is aimed to reach all patients who agreed to participate in the study and who met the inclusion criteria of the study, rather than using the research sample selection method. However, this data does not show the number of patients who applied to the unit because of the repeated visits of the patients during the chemotherapy treatment process. For this reason, direct sample selection was not made in the study, and the sample calculation was made according to the number of patients registered in the unit and the results of previous research. Calculations were made using the "G.Power-3.17" program with 95% confidence, an effect size of 0.4, and a statistical test power of at least 80%. Accordingly, it was aimed to reach 126 patients, at least 42 in each group.However, since the losses will be ignored, it is aimed to reach 150 patients in total. The hypotheses of the research;
H0,1: In patients receiving chemotherapy, the vein imaging device has no effect on the successful PIVC procedure by determining the appropriate vein.
H1,1: In patients receiving chemotherapy, the vein imaging device has an effect on the successful PIVC procedure by determining the appropriate vein.
H2: Vascular imaging device has a lower value in terms of pain in the PIVC procedure in patients receiving chemotherapy.
H3: In patients receiving chemotherapy, the vascular imaging device has a lower level of fear in the PIVC procedure.
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
- None
盲法说明
The intervention and measurements will carried out by the researcher (for hand manipulation standard) and the patients will discovered their own groups when intervention will applied to them. Because of the nature of the intervention, blinding will not be performed.
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have undergone chemotherapy treatment and have received their first cure,
- •patients between the ages of 18 and 74,
- •patients who have not allergic to any substance,
- •patients who no peripheral vascular disease,
- •patients who does not have a chronic disease diagnosed other than cancer,
- •patients who does not use alcohol,
- •patients who non-smoker,
- •patients who not taking anticoagulant treatment,
- •patients who no signs of infiltration and phlebitis,
- •patients who have not acute trauma around the extremity, inflammation, ecchymosis, hematoma, scar tissue, edema, metal prosthesis, no paralysis,
- •patients who no visible deformity and thrombocytopenia in the examination,
- •patient who mastectomy has not been performed,
- •patients who do not have communication problems and whose mental level is suitable to participate in the research will be taken.
排除标准
- •patients who have under the age of 18 and over the age of 74,
- •patients who will receive chemotherapy for the first time,
- •patients who changing chemotherapy cure treatment,
- •patients who allergic to any substance,
- •patients who do not volunteer to participate in the study will not be included in the study.
研究组 & 干预措施
Vascular imaging device with the infrared light group
The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data obtained on PIVC placement; vein visibility, the catheter number used in the procedure, the time to identify the appropriate vein, the successful PIVC placement time, the number of attempts for successful catheter placement, the vein in which the catheter was placed, the pain and fear levels before, during and after the procedure. These data will be recorded in the data form regarding the PIVC application. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.
干预措施: Vascular imaging (Other)
Vascular access transillumination group
The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse. The vein imaging device will be opened with transilluminator, the tourniquet will be connected, and the vein visibility will be re-evaluated by the operator. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data obtained on PIVC placement; the pain and fear levels before, during and after the procedure. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.
干预措施: Vascular imaging (Other)
Control group
The patient's vital signs, skin color, and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse. Vein imaging will not be performed. No intervention will be carried out the tourniquet will be connected, and the vein visibility will be re-evaluated by the operator. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data will obtained on PIVC placement; the pain and fear levels before, during, and after the procedure. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.
结局指标
主要结局
Visual Analog Scale (Pain)
时间窗: through study completion, an average of 1 year
It is a one-dimensional scale used in the measurement of VAS pain. Among the one-dimensional scales used to determine the severity of pain in patients, it was determined that the VAS measures more sensitively and is more reliable. The scale consists of a 100 mm long horizontal line. On one end are the phrases "No Pain" and on the other end "Unbearable Pain" describing the most severe pain possible. The patient is asked to mark his pain on the scale. The length of the line from the starting point of the scale to the point marked by the patient is measured and recorded in mm. It includes minimum 0 point, maximum 100 points.
次要结局
- Visual Analog Scale (Fear)(through study completion, an average of 1 year)
研究者
Hulya Yilmaz
Principal Investigator, PhD, Msc
Uludag University