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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05678504
Other study ID # Blood vessel imaging device
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date April 15, 2022

Study information

Verified date December 2022
Source Sakarya University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The study was planned to determine the effect of using a blood vessel imaging device (VID) and venous blood collection procedure on the pain and satisfaction level of the individual during phlebotomy. The randomized controlled experimental design study was carried out in a blood collection unit in a training and research hospital between 1-15 April 2022. The study sample was calculated as 100 people by power analysis and the method of drawing lots was applied to the groups. Data were collected using the patient identification form, visual analogue scale (VAS), and pain and satisfaction scales.


Description:

The population of the study consisted of adult individuals who benefited from polyclinic services and applied to the blood collection unit between the specified dates in a single center.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 15, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Individuals between the ages of 18-65, - Who wanted peripheral vascular access, - Volunteered to participate in the study, - Did not have any pain complaints, - Did not take analgesics in the last 12 hours, - Could be contacted, - Did not have obesity, dehydration, peripheral oedema, or a cancer diagnosis and did not need emergency intervention. Exclusion Criteria: - Those who do not meet the criteria for admission

Study Design


Related Conditions & MeSH terms


Intervention

Device:
The phlebotomy procedure
The process of blood collection with a vascular imaging device

Locations

Country Name City State
Turkey Sakarya training and research hospital Sakarya Adapazari

Sponsors (1)

Lead Sponsor Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Amick AE, Feinsmith SE, Sell J, Davis EM, Wayne DB, Feinglass J, Barsuk JH. Ultrasound-Guided Peripheral Intravenous Catheter Insertion Training Reduces Use of Midline Catheters in Hospitalized Patients With Difficult Intravenous Access. J Patient Saf. 2022 Apr 1;18(3):e697-e703. doi: 10.1097/PTS.0000000000000910. — View 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: — 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. — View Citation

Guillon P, Makhloufi M, Baillie S, Roucoulet C, Dolimier E, Masquelier AM. Prospective evaluation of venous access difficulty and a near-infrared vein visualizer at four French haemophilia treatment centres. Haemophilia. 2015 Jan;21(1):21-6. doi: 10.1111/hae.12513. Epub 2014 Oct 21. — View Citation

Kim K, Jeong HW, Lee Y. Performance Evaluation of Dorsal Vein Network of Hand Imaging Using Relative Total Variation-Based Regularization for Smoothing Technique in a Miniaturized Vein Imaging System: A Pilot Study. Int J Environ Res Public Health. 2021 F — View Citation

Morata L, Bowers M. Ultrasound-Guided Peripheral Intravenous Catheter Insertion: The Nurse's Manual. Crit Care Nurse. 2020 Oct 1;40(5):38-46. doi: 10.4037/ccn2020240. — View Citation

Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976 Nov;31(9):1191-8. doi: 10.1111/j.1365-2044.1976.tb11971.x. — View Citation

Skulec R, Callerova J, Vojtisek P, Cerny V. Two different techniques of ultrasound-guided peripheral venous catheter placement versus the traditional approach in the pre-hospital emergency setting: a randomized study. Intern Emerg Med. 2020 Mar;15(2):303- — View Citation

Yilmaz Kurt F, Aytekin Ozdemir A, Atay S. The Effects of Two Methods on Venipuncture Pain in Children: Procedural Restraint and Cognitive-Behavioral Intervention Package. Pain Manag Nurs. 2020 Dec;21(6):594-600. doi: 10.1016/j.pmn.2019.09.002. Epub 2019 O — View Citation

Zhang Z, Wang X, Zhang L, Lou X, Su X, Wang X, Sun F, He X. Infrared Vein Imaging for Insertion of Peripheral Intravenous Catheter for Patients Requiring Isolation for Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Nonrandomized Clinical Tri — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The effect of using a blood vessel imaging device on the pain of the phlebotomy procedure Blood vessel imaging device effective pain level one month
Secondary The effect of using a blood vessel imaging device on satisfaction level during the phlebotomy procedure Blood vessel imaging device effective satisfaction level one month
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