Pain Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | November 30, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | University of Ege, Faculty of Medicine, Hospital of Oncology | Izmir, | Bornova |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
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: — View Citation
Chapman LL, Sullivan B, Pacheco AL, Draleau CP, Becker BM. VeinViewer-assisted Intravenous catheter placement in a pediatric emergency department. Acad Emerg Med. 2011 Sep;18(9):966-71. doi: 10.1111/j.1553-2712.2011.01155.x. Epub 2011 Aug 19. — View 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. — View 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. — View Citation
Francisco MD, Chen WF, Pan CT, Lin MC, Wen ZH, Liao CF, Shiue YL. Competitive Real-Time Near Infrared (NIR) Vein Finder Imaging Device to Improve Peripheral Subcutaneous Vein Selection in Venipuncture for Clinical Laboratory Testing. Micromachines (Basel). 2021 Mar 30;12(4):373. doi: 10.3390/mi12040373. — View Citation
Hausfeld K, Baker RB, Boettcher-Prior P, Hancock D, Helms C, Jablonski T, Lin L, Menne K, Mittermeier J, Morris M. Randomized Prospective Clinical Trial Comparing Room Temperature and Warmed Intravenous Fluid Boluses on Pediatric Patients' Comfort. J Pediatr Nurs. 2015 Nov-Dec;30(6):e3-9. doi: 10.1016/j.pedn.2015.07.006. Epub 2015 Aug 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Vein Visibility | Vein visibility were recorded in real time as excellent = easily visible; medium =moderately visible or only perceived by light touch; poor = not visible and not perceived by touch by the operator student (Aulagnier et al., 2014). | through study completion, an average of 1 year | |
Primary | Visual Analog Scale | 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. | through study completion, an average of 1 year | |
Secondary | Arm Comfort Scale | The arm comfort has been developed based on VAS. The patient's subjective arm comfort evaluation at the 5th, 30th and 60th minutes before and after the PIVC administeration will be recorded on the form.
A 10 cm vertical visual analog scale will be used to evaluate the arm comfort felt by individuals during the procedure, with one end showing the discomfort and the other the best possible comfort (Hausfeld et al., 2015). |
through study completion, an average of 1 year |
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