Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-06 @ 2:20 PM
Study NCT ID:
NCT03202433
Status:
UNKNOWN
Last Update Posted:
2017-11-28
First Post:
2017-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduce Stress Associated With Needle Aspiration, in Voluntary and Replacement Blood Donors
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': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blocks swapped.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Allocation of two groups (Study and Control)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-30'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11-24'}, 'lastUpdateSubmitDate': '2017-11-24', 'studyFirstSubmitDate': '2017-06-18', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical scale of pain (EN)', 'timeFrame': 'Once finalized the donation that should last a maximum of 15 minutes.', 'description': 'Main measure for pain perception'}], 'secondaryOutcomes': [{'measure': 'Heart rate. Measurement with automatic equipment', 'timeFrame': 'Before donating, after the puncture and after the extraction of the needle.Maximum duration of the procedure, 15 minutes', 'description': 'Measure for the perception of stress'}, {'measure': 'Blood pressure. Measurement with automatic equipment', 'timeFrame': 'Before donating, after the puncture and after the extraction of the needle.Maximum duration of the procedure, 15 minutes', 'description': 'Measure for the perception of stress'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Stress Reduction', 'Needle Aspiration', 'Blood Donors', 'Intervention'], 'conditions': ['Stress']}, 'referencesModule': {'availIpds': [{'url': 'http://www.researchgate.net/publication/287542931_Psychological_coping_with_invasive_and_painful_medical_procedures_in_the_treatment_of_childhood_and_adolescent_cancer_The_cognitive-behavioural_approach', 'type': 'Clinical Study Report'}, {'id': 'ISSN 0124-8146', 'url': 'http://scielo.org.co/scielo.php?script=sci_arttext&pid=S0124-81462013000200010', 'type': 'Study Protocol'}, {'url': 'http://www.criscancer.org', 'type': 'Clinical Practice Guide'}], 'references': [{'pmid': '20543263', 'type': 'BACKGROUND', 'citation': 'Riva G, Raspelli S, Pallavicini F, Grassi A, Algeri D, Wiederhold BK, Gaggioli A. Interreality in the management of psychological stress: a clinical scenario. Stud Health Technol Inform. 2010;154:20-5.'}, {'pmid': '19272275', 'type': 'BACKGROUND', 'citation': 'Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.'}]}, 'descriptionModule': {'briefSummary': 'Reduce stress associated with needle aspiration, in voluntary and replacement blood donors.\n\nThis study has not been completed.', 'detailedDescription': 'The purpose of the study is to investigate the effectiveness of Virtual Reality (as a form of distraction) to reduce the stress associated with extraction needle puncture in the volunteer blood donors and reposition of Fixed Collection of the Valparaiso Blood Center, Of the Valparaíso San Antonio Health Service.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand and / or visualize the numerical scale of pain\n* Spanish spoken\n* Greater than 50 Kilograms of weight\n* Blood hemoglobin: Greater than 12.5 g% in women and greater than 13.5 g% in men\n* Have been accepted as a blood donor.\n\nExclusion Criteria:\n\n* Unable to understand and / or visualize the numerical scale of pain\n* Does not speak Spanish\n* Less than 50 Kilograms\n* Blood hemoglobin: Less than 12.5 g% in women and less than 13.5 g% in men.\n* Have been rejected as a blood donor.'}, 'identificationModule': {'nctId': 'NCT03202433', 'briefTitle': 'Reduce Stress Associated With Needle Aspiration, in Voluntary and Replacement Blood Donors', 'organization': {'class': 'OTHER', 'fullName': 'Center for Blood and Tissues IV and V Region, Chile'}, 'officialTitle': 'Use of Virtual Reality in Blood Donors, an Innovative Tool', 'orgStudyIdInfo': {'id': 'ORD1083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Distractor', 'description': 'The objective is to apply a technique, using virtual reality lenses, with relaxing audio-visual contents of no more than ten minutes, to reduce stress before and during the blood donation process and to respond to the level of pain perceived during donation, either post-puncture and withdrawal of the needle', 'interventionNames': ['Device: Use of virtual reality lenses, with relaxing audio-visual contents']}, {'type': 'NO_INTERVENTION', 'label': 'Traditional Blood Donation Process', 'description': 'The objective is to respond to the level of pain perceived during donation, either post-puncture and withdrawal of the needle, without virtual reality support'}], 'interventions': [{'name': 'Use of virtual reality lenses, with relaxing audio-visual contents', 'type': 'DEVICE', 'description': 'Use of virtual reality lenses (and audio) as a distraction for the blood donor patients.', 'armGroupLabels': ['Virtual Reality Distractor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2340000', 'city': 'Valparaíso', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Octavio Guzmán', 'role': 'CONTACT', 'email': 'octavio.guzman@redsalud.gov.cl', 'phone': '+56961907508'}, {'name': 'Pedro Meneses', 'role': 'CONTACT', 'email': 'pedro.meneses@redsalud.gov.cl', 'phone': '322571678'}], 'facility': 'Blood and Tissue Center', 'geoPoint': {'lat': -33.036, 'lon': -71.62963}}], 'centralContacts': [{'name': 'Octavio Guzmán', 'role': 'CONTACT', 'email': 'octavio.guzman@redsalud.gov.cl', 'phone': '+56961907508'}, {'name': 'Francisco Rendich', 'role': 'CONTACT', 'email': 'frendich@gmail.com', 'phone': '+56945582922'}], 'overallOfficials': [{'name': 'Pedro Meneses', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical College of Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Blood and Tissues IV and V Region, Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Technologist', 'investigatorFullName': 'Adrián Erich Goecke Varela', 'investigatorAffiliation': 'Center for Blood and Tissues IV and V Region, Chile'}}}}