Trial Title:
The Effects of Three Different Techniques During PIVC
NCT ID:
NCT05847816
Condition:
Pain
Arm
Visual Aura
Infrared; Rays, Injury
Conditions: Keywords:
near-infrared light
peripheral intravenous cannulation
pain
arm comfort
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 TY (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:
Experimental group: infrared vascular imaging
Description:
Experimental group - infrared vascular imaging;Before PIVC, infrared light will be
directed to the vein area and the procedure will be started after vein visibility is
achieved.
Experimental group - isometric hand exercise; Stress balls will be given to patients 10
minutes before the PIVC procedure and they will be asked to perform hand-clamping
exercises with both hands. Processing will then begin.
Arm group label:
Experimental group: infrared vascular imaging
Arm group label:
Experimental group: isometric hand exercise
Other name:
Experimental group: isometric hand exercise
Summary:
Purpose: This study will conducted to the effect of three different techniques used
during peripheral intravenous cannulation (PIVC) application on vein visibility, pain and
comfort in cancer patients receiving palliative care.
Design: This is a prospective, randomized controlled experimental study. Methods: The
population of the research will be cancer patients who applied to Ege University Medical
Faculty Hospital Oncology unit between April 2023 and November 2024. The number of
applications due to palliative care and cancer treatment in the clinic in 2021 is 352
patients. 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 (Chiao et al., 2013; Aulagnier et al., 2014).
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 120 patients, including at least 40 in each group. In the study, randomization will
be made according to vein visibility.
Detailed description:
Purpose: This study will conducted to the effect of three different techniques used
during peripheral intravenous cannulation (PIVC) application on vein visibility, pain and
comfort in cancer patients receiving palliative care. We will implement of the study
during the insert on PIVC; the vascular imaging device group; isometric hand exercise
group and control group.
Design: This is a prospective, randomized controlled experimental study.
Methods: Implementation of the study in the control group: The patient's vital signs,
skin color and skin turgor will be evaluated and recorded in the peripheral intravenous
chemotherapy application registration form. Since it is stated in the literature that the
placement of the PIVK in the arm that is not actively used is important in preventing
complications, PIVK will be placed in the arm that the patient does not actively use in
groups (Ingram and Lavery, 2005; INS, 2011). After the tourniquet is attached, the
stopwatch will be started and the catheter intervention process will be started when the
vein visibility reaches the level where the nurse can insert the catheter. The stopwatch
will be terminated at the stage of advancing the branule into the vein and fixing it with
a plaster. If the catheterization application is successful or unsuccessful in the first
attempt, it will be recorded. PIC success will be evaluated according to whether the
branule is placed in the vein. Successful catheter insertion will be considered as blood
coming into the chamber of the catheter. If the vein cannot be entered or blood is not
coming to the catheter, the catheterization will be considered unsuccessful. Patients
with two unsuccessful attempts per group will be excluded from the study, as more than
two unsuccessful attempts may result in infiltration (INS, 2011). Vein visibility after
tourniquet application, catheter number used in the procedure, time to determine the
appropriate vein, successful catheter placement time, number of attempts for successful
catheter placement will be recorded in the intravenous chemotherapy application
registration form. The pain and arm comfort levels in the form will be evaluated on a
scale ranging from 0 to 10, with 0: none, 10: many, before and after the application (at
the 5th, 30th, and 60th minutes).
Implementation of the study in the vascular imaging device group: The patient's vital
signs, skin color and skin turgor will be evaluated and recorded in the peripheral
intravenous chemotherapy application registration form. After the tourniquet is attached,
the stopwatch will be started and the catheter intervention process will be started when
the vein visibility reaches the level where the nurse can insert the catheter. The
stopwatch will be terminated at the stage of advancing the branule into the vein and
fixing it with a plaster. If the catheterization application is successful or
unsuccessful in the first attempt, it will be recorded. PIC success will be evaluated
according to whether the branule is placed in the vein. Successful catheter insertion
will be considered as blood coming into the chamber of the catheter. Patients with two
unsuccessful attempts per group will be excluded from the study, as more than two
unsuccessful attempts may result in infiltration (INS, 2011). Vein visibility after
tourniquet application, catheter number used in the procedure, time to determine the
appropriate vein, successful catheter placement time, number of attempts for successful
catheter placement will be recorded in the intravenous chemotherapy application
registration form. The pain and arm comfort levels in the form will be evaluated on a
scale ranging from 0 to 10, with 0: none, 10: many, before and after the application (at
the 5th, 30th, and 60th minutes).
Isometric hand exercise: The patients to be included in this group will have applied
isometric hand squeeze exercise, which lasted for twenty minutes a day, five days a week,
before the PIVK procedure. On the fifth day, the patient's vital signs, skin color and
skin turgor will be evaluated and recorded in the peripheral intravenous chemotherapy
application registration form. Patients will be told how to use the stress ball 5 minutes
before and during the PIVK procedure before the procedure. Patients will be taught to
count from one to three and tighten and loosen the stress ball once, and they will be
told to continue squeezing and loosening the stress ball in this way until the procedure
is over. Focus their attention on the stress ball during the procedure
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patients who not allergic to any substance,
- patients who not peripheral vascular disease
- patients who not having a chronic disease other than cancer,
- patients who non alcoholic
- patients who non-smoker
- patients who nottaking anticoagulant therapy
- patients who no signs of infiltration and phlebitis, acute trauma around the
extremity, inflammation, ecchymosis, hematoma, scar tissue, edema, metal prosthesis,
no paralysis,
- patients who no noticeable deformity and thrombocytopenia in the examination,
- patients who no mastectomy was performed,
- patients who do not have communication problems and whose mental level is suitable
for participating in the research
Exclusion Criteria:
- patients have advanced reading comprehension problems
- patients have severe hearing impairment
- patients have under 18 years of age,
- patients have who will receive chemotherapy for the first time,
- patients have change chemotherapy cure treatment,
- patients have allergic to any substance,
- patients who did not volunteer to participate in the study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Ege, Faculty of Medicine, Hospital of Oncology
Address:
City:
İzmir,
Zip:
35100
Country:
Turkey
Contact:
Last name:
Turgay Yalcinkaya, Msc
Phone:
+90 536 704 63 05
Email:
turgayyalcinkaya35@gmail.com
Start date:
May 17, 2023
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Ege University
Agency class:
Other
Source:
Ege University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05847816
