Trial Title:
The Effect of Infrared Light Use in Oncology Patients Receiving Chemotherapy
NCT ID:
NCT05892978
Condition:
Pain
Fear Needles
Satisfaction, Patient
Conditions: Keywords:
Near-infrared light
Transilluminator
Peripheral intravenous cannulation
Vascular access
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a prospective, randomized controlled experimental study.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Masking description:
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.
Intervention:
Intervention type:
Other
Intervention name:
Vascular imaging
Description:
Experimental group - Vascular imaging device with the infrared light group: Before PIVC,
infrared light will be directed to the vein area and the procedure will be started after
vein visibility is achieved.
Experimental group - Vascular access transillumination group: Before PIVC, a
transilluminator will be inserted to the vein area and the procedure will be started
after vein visibility is achieved
Arm group label:
Vascular access transillumination group
Arm group label:
Vascular imaging device with the infrared light group
Other name:
Vascular imaging device with the infrared light group
Other name:
Vascular access transillumination group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
74 Years
Healthy volunteers:
No
Start date:
June 17, 2023
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Uludag University
Agency class:
Other
Source:
Uludag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05892978
