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PainNCT05847816

The Effects of Three Different Techniques During PIVC

A study testing Experimental group: infrared vascular imaging in people with Pain and Arm, run by Ege University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Arm, Visual Aura
What is being tested?
Experimental group: infrared vascular imaging
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 May 2023to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

SEBNEM CINAR YUCEL, Prof, PhD contact

+905073752579

sebnemcinar@gmail.com

Turkey (Türkiye)1 site
  • University of Ege, Faculty of Medicine, Hospital of Oncology

    Izmir, Bornova, 35100

    Turgay Yalcinkaya, Msc, +90 536 704 63 05, turgayyalcinkaya35@gmail.com

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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

Being tested
Experimental group: infrared vascular imaging
Keywords
near-infrared light, peripheral intravenous cannulation, pain, arm comfort
Medical subject headings
Pain, Epilepsy, Partial, Sensory, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental group: infrared vascular imagingOther

    Also called Experimental group: isometric hand exercise

    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.

Study groups in NCT05847816
Study groupRoleWhat they receive
Experimental group: infrared vascular imagingExperimentalThe 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).
Receives: Other: Experimental group: infrared vascular imaging
Experimental group: isometric hand exerciseExperimentalThe 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.
Receives: Other: Experimental group: infrared vascular imaging
Control group: no interventionNo 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)
  1. 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).

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2023
  2. Study start17 May 2023 (estimated)
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion30 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, randomized controlled experimental study.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05847816
Sponsor's protocol ID
28/09/2022 - 713/693
Status last verified
May 2023
First submitted
3 Apr 2023
Last updated
8 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 23384732
  • 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.

    PubMed 21854488
  • 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.

    PubMed 33808493
  • 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.

    PubMed 26277355
  • 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.

    PubMed 33654007
  • 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.

    PubMed 25176152

Questions about this trial

What is this clinical trial studying?

A study testing Experimental group: infrared vascular imaging in people with Pain and Arm, run by Ege University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Turgay Yalcinkaya (+905367046305, turgayyalcinkaya35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05847816, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023; AzTrials last refreshed its copy on 31 Oct 2026.

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