Clinical trial NCT05892978: The Effect of Infrared Light Use in Oncology Patients Receiving Chemotherapy
Official title: The Effect of Infrared Light Use on Pain, Fear, and Patient Satisfaction During Peripheral Intravenous Catheter (PIVC) Procedure in Oncology Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Fear Needles
Satisfaction, Patient
Keywords: Near-infrared light
Transilluminator
Peripheral intravenous cannulation
Vascular access
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized controlled experimental study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

H4: In patients receiving chemotherapy, vascular imaging device is higher in terms of patient satisfaction in PIVC procedure.

Implementation of the study in the vascular imaging device with the infrared light group: The patient will be taken to the chemotherapy application chair and rested. The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Since it is stated in the literature that the placement of the peripheral intravenous catheter in the unused arm is important in preventing complications, the PIVC procedure will be performed in the arm that the patient does not actively use. 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 infrared light, the tourniquet will be connected, and the vein visibility will be re-evaluated by the research nurse. As soon as the turnstile is connected, the stopwatch will be started. Then the PIVC placement process will be started with the help of the device. 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 branule. If there is no blood, the attempt will be considered unsuccessful. In unsuccessful cases, the PIVC attempt will be repeated up to two times in each patient. All procedures will be performed by a single research nurse to ignore the operator hand manipulation difference. 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 PIK application. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion. The satisfaction levels in the form will be evaluated on a scale ranging from 0 to 10, with 0: none, 10: many, after the application. These data will be recorded in the data form on PIVC transaction satisfaction.

Implementation of the study in the vascular access transillumination group: The processes will be repeated exactly. Transilluminator will be used instead of infrared light.

Implementation of the study in the control group: The processes will be repeated exactly. No intervention will be made for vascular access.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Analog Scale (Pain)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Visual Analog Scale (Fear)
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Patient satisfaction
timeFrame: through study completion, an average of 1 year
Locations:
Study officials:
References:
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citation: Chiao FB, Resta-Flarer F, Lesser J, Ng J, Ganz A, Pino-Luey D, Bennett H, Perkins C Jr, Witek B. Vein visualization: patient characteristic factors and efficacy of a new infrared vein finder technology. Br J Anaesth. 2013 Jun;110(6):966-71. doi: 10.1093/bja/aet003. Epub 2013 Feb 5.
citation: Eren H, Caliskan N. Effect of a Vein Imaging Device and of Fist Clenching on Determination of an Appropriate Vein and on Catheter Placement Time in Patients Receiving Chemotherapy: A Randomized Controlled Trial. Cancer Nurs. 2022 Mar-Apr 01;45(2):105-112. doi: 10.1097/NCC.0000000000000931.