Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT05678504
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2022-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Process of Blood Collection With a Vascular Imaging Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-28', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-12-28', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of using a blood vessel imaging device on the pain of the phlebotomy procedure', 'timeFrame': 'one month', 'description': 'Blood vessel imaging device effective pain level'}], 'secondaryOutcomes': [{'measure': 'The effect of using a blood vessel imaging device on satisfaction level during the phlebotomy procedure', 'timeFrame': 'one month', 'description': 'Blood vessel imaging device effective satisfaction level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phlebotomy', 'blood vessel imaging device', 'pain', 'satisfaction'], 'conditions': ['Phlebotomy']}, 'referencesModule': {'references': [{'pmid': '25335191', 'type': 'BACKGROUND', '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.'}, {'pmid': '34570003', 'type': 'BACKGROUND', 'citation': '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': '1015603', 'type': 'BACKGROUND', '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.'}, {'pmid': '33561967', 'type': 'RESULT', '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 Feb 6;18(4):1548. doi: 10.3390/ijerph18041548.'}, {'pmid': '35115182', 'type': 'RESULT', '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 Trial. J Emerg Nurs. 2022 Mar;48(2):159-166. doi: 10.1016/j.jen.2021.10.001. Epub 2021 Oct 12.'}, {'pmid': '25176152', 'type': 'RESULT', '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: 10.1111/acem.12437.'}, {'pmid': '33654007', 'type': 'RESULT', '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. doi: 10.1097/NCC.0000000000000931.'}, {'pmid': '33000131', 'type': 'RESULT', '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."}, {'pmid': '31701317', 'type': 'RESULT', '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):303-310. doi: 10.1007/s11739-019-02226-w. Epub 2019 Nov 7.'}, {'pmid': '31628067', 'type': 'RESULT', '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 Oct 15.'}], 'seeAlsoLinks': [{'url': 'https://www.infona.pl/resource/bwmeta1.element.elsevier-1d4b899a-3c22-30c7-a988-a5990180d27b', 'label': 'Zhu, Q., Zhang, Z., Liu, N., \\& Sun, H. (2015). Near infrared hand vein image acquisition and extraction algorithm. Optics, 126(24), 5682-5687.'}, {'url': 'http://journal.acibadem.edu.tr/tr/download/article-file/1701903', 'label': 'CURRENT APPROACH TO PEDIATRIC VASCULAR ACCESS APPLICATIONS: VESSEL VISUALIZATION TECHNIQUE'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '50 application grup 50 control grup', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals between the ages of 18-65,\n* Who wanted peripheral vascular access,\n* Volunteered to participate in the study,\n* Did not have any pain complaints,\n* Did not take analgesics in the last 12 hours,\n* Could be contacted,\n* Did not have obesity, dehydration, peripheral oedema, or a cancer diagnosis and did not need emergency intervention.\n\nExclusion Criteria:\n\n* Those who do not meet the criteria for admission'}, 'identificationModule': {'nctId': 'NCT05678504', 'acronym': 'VID', 'briefTitle': 'The Process of Blood Collection With a Vascular Imaging Device', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya University'}, 'officialTitle': 'The Effect of Using Blood Vessel Imaging Device on Pain and Satisfaction Level During the Phlebotomy Procedure', 'orgStudyIdInfo': {'id': 'Blood vessel imaging device'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Application Group', 'description': '* Filling out the pre-initiative volunteering form and sociodemographic data\n* Preparation of the individual for the transaction\n* Monitoring the vein with a vein imaging device and operating a stopwatch\n* Implementation of the initiative\n* Stopping the stopwatch at the end of the process\n* Application of VAS Pain and VAS satisfaction Scale', 'interventionNames': ['Device: The phlebotomy procedure']}, {'label': 'Control Group', 'description': '* Filling out the pre-initiative volunteering form and sociodemographic data\n* Preparation of the individual for the transaction\n* Starting routine blood collection and starting the stopwatch\n* Implementation of the initiative\n* Stopping the stopwatch at the end of the process\n* Application of VAS Pain and VAS satisfaction Scale'}], 'interventions': [{'name': 'The phlebotomy procedure', 'type': 'DEVICE', 'description': 'The process of blood collection with a vascular imaging device', 'armGroupLabels': ['Application Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54100', 'city': 'Sakarya', 'state': 'Adapazarı', 'country': 'Turkey (Türkiye)', 'facility': 'Sakarya training and research hospital', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}], 'overallOfficials': [{'name': 'özlem doğu, assoc. dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sakarya University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakarya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Dr.', 'investigatorFullName': 'özlem doğu', 'investigatorAffiliation': 'Sakarya University'}}}}