NCT05678504

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
Last Updated

January 10, 2023

Status Verified

December 1, 2022

Enrollment Period

14 days

First QC Date

October 10, 2022

Last Update Submit

December 28, 2022

Conditions

Keywords

Phlebotomyblood vessel imaging devicepainsatisfaction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The effect of using a blood vessel imaging device on satisfaction level during the phlebotomy procedure

    one month

Study Arms (2)

Application Group

* Filling out the pre-initiative volunteering form and sociodemographic data * Preparation of the individual for the transaction * Monitoring the vein with a vein imaging device and operating a stopwatch * Implementation of the initiative * Stopping the stopwatch at the end of the process * Application of VAS Pain and VAS satisfaction Scale

Device: The phlebotomy procedure

Control Group

* Filling out the pre-initiative volunteering form and sociodemographic data * Preparation of the individual for the transaction * Starting routine blood collection and starting the stopwatch * Implementation of the initiative * Stopping the stopwatch at the end of the process * Application of VAS Pain and VAS satisfaction Scale

Interventions

The process of blood collection with a vascular imaging device

Application Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

50 application grup 50 control grup

You may qualify if:

  • 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.

You may not qualify if:

  • Those who do not meet the criteria for admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya training and research hospital

Sakarya, Adapazarı, 54100, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    PMID: 25335191BACKGROUND
  • 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.

    PMID: 34570003BACKGROUND
  • 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.

    PMID: 1015603BACKGROUND
  • 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 Feb 6;18(4):1548. doi: 10.3390/ijerph18041548.

  • 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 Trial. J Emerg Nurs. 2022 Mar;48(2):159-166. doi: 10.1016/j.jen.2021.10.001. Epub 2021 Oct 12.

  • 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.

  • 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.

  • 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.

  • 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):303-310. doi: 10.1007/s11739-019-02226-w. Epub 2019 Nov 7.

  • 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 Oct 15.

Related Links

MeSH Terms

Conditions

PainPersonal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • özlem doğu, assoc. dr

    Sakarya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Dr.

Study Record Dates

First Submitted

October 10, 2022

First Posted

January 10, 2023

Study Start

April 1, 2022

Primary Completion

April 15, 2022

Study Completion

April 15, 2022

Last Updated

January 10, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations