The Effects of Three Different Techniques During PIVC
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started May 2023
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedStudy Start
First participant enrolled
May 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedMay 8, 2023
May 1, 2023
1.5 years
April 3, 2023
May 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Arm Comfort Scale
through study completion, an average of 1 year
Other Outcomes (1)
Vein Visibility
through study completion, an average of 1 year
Study Arms (3)
Experimental group: infrared vascular imaging
EXPERIMENTALThe 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. 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).
Experimental group: isometric hand exercise
EXPERIMENTALThe 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.
Control group: no intervention
NO INTERVENTIONThe 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 stop watch 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. If the PIVC 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. 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ege Universitylead
Study Sites (1)
University of Ege, Faculty of Medicine, Hospital of Oncology
Izmir, Bornova, 35100, Turkey (Türkiye)
Related Publications (6)
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.
PMID: 23384732BACKGROUNDChapman 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.
PMID: 21854488BACKGROUNDFrancisco 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.
PMID: 33808493BACKGROUNDHausfeld 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.
PMID: 26277355BACKGROUNDEren 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.
PMID: 33654007BACKGROUNDAulagnier 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.
PMID: 25176152RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- 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
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, PhD, Msc
Study Record Dates
First Submitted
April 3, 2023
First Posted
May 8, 2023
Study Start
May 17, 2023
Primary Completion
November 30, 2024
Study Completion
November 30, 2024
Last Updated
May 8, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) doesn't share any other researchers. Only research team will see data on IPD. After the data collection phase is completed and turned into a publication, other researchers can access the publication.