PhlebotomyVIDNCT05678504
The Process of Blood Collection With a Vascular Imaging Device
An observational study of Phlebotomy, run by Sakarya University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Phlebotomy
- What is being tested?
- The phlebotomy procedure
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 15 Apr 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 application grup 50 control grup
Who may be able to join
- 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.
Who cannot join
- Those who do not meet the criteria for admission
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya training and research hospital
Sakarya, Adapazarı, 54100
About this study
Official title: The Effect of Using Blood Vessel Imaging Device on Pain and Satisfaction Level During the Phlebotomy Procedure
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.
Read the 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.
- Conditions
- Phlebotomy
- Being tested
- The phlebotomy procedure
- Keywords
- Phlebotomy, blood vessel imaging device, pain, satisfaction
- Medical subject headings
- Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The phlebotomy procedureDevice
The process of blood collection with a vascular imaging device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of using a blood vessel imaging device on the pain of the phlebotomy procedure
Blood vessel imaging device effective pain level
Measured: one month
Secondary outcomes (1)
The effect of using a blood vessel imaging device on satisfaction level during the phlebotomy procedure
Blood vessel imaging device effective satisfaction level
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Apr 2022
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PhlebotomyStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özlem doğu, Sakarya University
- Investigators
- özlem doğu, assoc. dr, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678504
- Sponsor's protocol ID
- Blood vessel imaging device
- Acronym
- VID
- Status last verified
- Dec 2022
- First submitted
- 10 Oct 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25335191Amick 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.
PubMed 34570003Revill 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.
PubMed 1015603Kim 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.
PubMed 33561967Zhang 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.
PubMed 35115182Aulagnier 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 25176152Eren 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 33654007Morata 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.
PubMed 33000131Skulec 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.
PubMed 31701317Yilmaz 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.
PubMed 31628067
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Blood Vessel Imaging Device on Pain and Satisfaction Level During the Phlebotomy Procedure
- ClinicalTrials.gov ID
- NCT05678504
- Acronym / sponsor ID
- VID / Blood vessel imaging device
- Conditions
- Phlebotomy
- Keywords
- Phlebotomy, blood vessel imaging device, pain, satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application Group | – | Device: The phlebotomy procedure* 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 |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 application grup 50 control grup
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (1 listed)
- Those who do not meet the criteria for admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The phlebotomy procedureThe process of blood collection with a vascular imaging device | Device | Application Group |
Primary outcome
The effect of using a blood vessel imaging device on the pain of the phlebotomy procedure
Time frame: one month
Blood vessel imaging device effective pain level
1 secondary outcome
The effect of using a blood vessel imaging device on satisfaction level during the phlebotomy procedure
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 25335191Guillon 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.
- Background: PubMed 34570003Amick 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.
- Background: PubMed 1015603Revill 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.
- Results publication: PubMed 33561967Kim 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.
- Results publication: PubMed 35115182Zhang 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.
- Results publication: PubMed 25176152Aulagnier 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.
- Results publication: PubMed 33654007Eren 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.
- Results publication: PubMed 33000131Morata 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.
- Results publication: PubMed 31701317Skulec 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.
- Results publication: PubMed 31628067Yilmaz 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.
- CURRENT APPROACH TO PEDIATRIC VASCULAR ACCESS APPLICATIONS: VESSEL VISUALIZATION TECHNIQUELink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
özlem doğu, assoc. dr principal investigator
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phlebotomy, run by Sakarya 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 10 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of using a blood vessel imaging device on the pain of the phlebotomy procedure (time frame: one month). 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 NCT05678504, which also lists 10 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 10 Jan 2023.