Clinical trial NCT05847816: The Effects of Three Different Techniques During PIVC
Official title: The Effects of Three Different Techniques During Peripheral Intravenous Cannulation (PIVC) Administered in Vein Visibility, Pain and Comfort in Cancer Patients Receiving Palliative Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Arm
Visual Aura
Infrared; Rays, Injury
Keywords: near-infrared light
peripheral intravenous cannulation
pain
arm comfort
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
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 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

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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Arm Comfort Scale
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Vein Visibility
timeFrame: through study completion, an average of 1 year
Locations:
city: İzmir,
country: Turkey
facility: University of Ege, Faculty of Medicine, Hospital of Oncology
state: Bornova
Study officials:
References:
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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.
citation: Aulagnier J, Hoc C, Mathieu E, Dreyfus JF, Fischler M, Le Guen M. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014 Aug;21(8):858-63. doi: 10.1111/acem.12437.