VID: The Process of Blood Collection With a Vascular Imaging Device

• Sponsor: Sakarya University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05678504
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Days): 14
• Patients Per Site Per Month: 217.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Phlebotomy	Device: The phlebotomy procedure

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: The Effect of Using Blood Vessel Imaging Device on Pain and Satisfaction Level During the Phlebotomy Procedure
• Actual Study Start Date: Apr 1, 2022
• Actual Primary Completion Date: Apr 15, 2022
• Actual Study Completion Date: Apr 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
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; The process of blood collection with a vascular imaging device
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

Outcome Measures

Primary Outcome Measures

1. The effect of using a blood vessel imaging device on the pain of the phlebotomy procedure [one month]

   Blood vessel imaging device effective pain level

Secondary Outcome Measures

1. The effect of using a blood vessel imaging device on satisfaction level during the phlebotomy procedure [one month]

   Blood vessel imaging device effective satisfaction level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sakarya training and research hospital	Sakarya	Adapazarı	Turkey	54100

Sponsors and Collaborators

• Sakarya University

Investigators

• Principal Investigator: özlem doğu, assoc. dr, Sakarya University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Zhu, Q., Zhang, Z., Liu, N., & Sun, H. (2015). Near infrared hand vein image acquisition and extraction algorithm. Optics, 126(24), 5682-5687.
• The Effect of Vibration on Pain and Anxiety During Intravenous Blood Sampling in Adults
• CURRENT APPROACH TO PEDIATRIC VASCULAR ACCESS APPLICATIONS: VESSEL VISUALIZATION TECHNIQUE

Publications

• 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.
• 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.
• 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.

• Responsible Party: özlem doğu, Assoc. Dr., Sakarya University
• ClinicalTrials.gov Identifier: NCT05678504
• Other Study ID Numbers: Blood vessel imaging device
• First Posted: Jan 10, 2023
• Last Update Posted: Jan 10, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by özlem doğu, Assoc. Dr., Sakarya University: Phlebotomy; blood vessel imaging device; pain; satisfaction

Study Results

No Results Posted as of Jan 10, 2023