Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-28 @ 12:05 PM
Study NCT ID:
NCT06569004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-23
First Post:
2024-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IR Beam Used Before Peripheral Intravenous Catheter Application on Vein Visibility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2024-01-15', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of IR beam used before peripheral intravenous catheter application', 'timeFrame': '6 mounths', 'description': 'question form'}], 'secondaryOutcomes': [{'measure': 'Effect of IR beam on pain', 'timeFrame': '6 mounths', 'description': 'Pain scale'}, {'measure': 'Effect of IR beam on anxiety', 'timeFrame': '6 mounths', 'description': 'Anxiety scale'}, {'measure': 'Effect of IR beam on satisfaction', 'timeFrame': '6 mounths', 'description': 'Satisfaction scale'}, {'measure': 'Effect of IR beam on application', 'timeFrame': '6 mounth', 'description': 'Question form'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vein', 'intravenous', 'nurse'], 'conditions': ['Questionnaire']}, 'descriptionModule': {'briefSummary': "The study will be conducted in the Oncology and Cardiovascular Surgery (CVS) services of a university hospital. In the research, 30 patients will constitute the control group and 30 patients will constitute the experimental group. A nurse working in the clinics where the study will be conducted will perform the PIVK procedure, and we will randomly select the control and experimental groups and apply light to the area where the PIVK will be applied to the patients in the experimental groups with a flashlight that emits infrared rays for 10 minutes. The nurse will not be aware of whether the radiation application was made to the patient or not. The veins will be evaluated by the nurse performing PIVK. We will fill out the necessary forms in ANNEX 1 (control group) and APPENDIX 2 (experimental group) while the PIVK procedure is applied. After the procedure is completed, the patient's pain, anxiety and satisfaction level during the procedure will be marked. The data will be entered into the SPSS program and evaluated with statistical tests. According to the results, the effect of IR rays used before PIVK application on the patient's pain, anxiety and satisfaction and on the procedure time spent by the nurse for the application will be determined.", 'detailedDescription': 'A nurse from the ward where the study will be conducted will be contacted and a meeting of approximately 20 minutes will be held about the study. The nurse will fill out the forms before and after inserting the catheter into the patient. Routine procedures such as tourniquet, hand opening and closing will be applied to the control group before catheter application. In the experimental group, catheter application will be made after the IR beam is applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAre between the ages of 18-70,\n\n* PIVK will be inserted,\n* Not receiving anticoagulant treatment,\n* Does not have diabetes or peripheral neuropathy,\n* No signs of infiltration or thrombophlebitis in the extremity where IR beam will be used,\n* Dialysis patients without arteriovenous fistula,\n* Does not have any communication problems and whose mental level does not cause any problems in participating in the research,\n* Patients who volunteer to participate in the research will be recruited.\n\nExclusion Criteria:\n\n* Sudden movements during PICK insertion,\n* Missing patient data'}, 'identificationModule': {'nctId': 'NCT06569004', 'briefTitle': 'IR Beam Used Before Peripheral Intravenous Catheter Application on Vein Visibility', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Karadeniz Technical University - Tubitak Student Project', 'orgStudyIdInfo': {'id': 'Karadeniz Tek. Univ. 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IR beam used before peripheral intravenous catheter application on vein visibility', 'description': 'IR beam application', 'interventionNames': ['Device: randomised study, two group (experimental and control)']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Only parenteral catheter application'}], 'interventions': [{'name': 'randomised study, two group (experimental and control)', 'type': 'DEVICE', 'otherNames': ['IR beam'], 'description': 'Use of IR beam before peripheral intravenous catheter application', 'armGroupLabels': ['IR beam used before peripheral intravenous catheter application on vein visibility']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61080', 'city': 'Trabzon', 'state': 'Ortahisar', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Merve Çiçek', 'role': 'CONTACT', 'email': 'mervecicek2961@gmail.com', 'phone': '4623778866'}, {'name': 'Hüdanur TOSUN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Şule BIYIK BAYRAM', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}, {'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Merve Çiçek', 'role': 'CONTACT', 'email': 'sulebiyik@gmail.com', 'phone': '4623778866'}, {'name': 'Hüdanur TOSUN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Şule', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}, {'zip': '61080', 'city': 'Trabzon', 'state': 'Üniversite', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hüdanur Tosun', 'role': 'CONTACT', 'email': 'hdnrtsnyo2325@gmail.com', 'phone': '4623778866'}, {'name': 'Merve ÇİÇEK', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Karadeniz Technical University Faculty of Health Sciences', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'centralContacts': [{'name': 'Şule Bıyık Bayram, phD', 'role': 'CONTACT', 'email': 'sulebiyik@gmail.com', 'phone': '4623778866'}, {'name': 'Merve ÇİÇEK', 'role': 'CONTACT', 'email': 'mervecicek2961@gmail.com', 'phone': '4633778866'}], 'overallOfficials': [{'name': 'Sule BIYIK BAYRAM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karadeniz Technical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor Karadeniz Technical University', 'investigatorFullName': 'Sule BIYIK BAYRAM', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}