Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-04 @ 1:36 PM
Study NCT ID:
NCT02969902
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buzzy Distraction During Venipuncture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073818', 'term': 'Pain, Procedural'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-16', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported pain', 'timeFrame': 'Within 5 minutes after the procedure', 'description': 'Children from 4 to 7 years of age record their pain using the Faces Pain Scale-Revised (FPS-R); children from 8 to 12 years using a Numerical Rating Scale, with scores from zero to 10.'}], 'secondaryOutcomes': [{'measure': 'Pain evaluated by parents', 'timeFrame': 'Within 5 minutes after the procedure', 'description': 'Pain evaluated using a Numerical Rating Scale, with scores from zero to 10'}, {'measure': 'Pain evaluated by nurses', 'timeFrame': 'Within 5 minutes after the procedure', 'description': 'Pain evaluated using a Numerical Rating Scale, with scores from zero to 10'}, {'measure': 'Success at first attempt', 'timeFrame': 'Intraprocedural', 'description': 'Percentage of success at first attempt'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 15 minutes after the procedure', 'description': 'The number and the type of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Procedural pain', 'Phlebotomy', 'Distraction', 'Hand-held computer', 'Children'], 'conditions': ['Pain Relief']}, 'descriptionModule': {'briefSummary': "Venipuncture is one of the most common iatrogenic painful and stressful procedures performed on children. Interventions aimed at reducing the distress related to this experience are widely and strongly recommended. Pain and anxiety management is even more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture related pain and distress, with a strong evidence supporting its efficacy in children and adolescents.\n\nIn recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines distraction and physical analgesia (vibration and cold) and it was positively tested during venipuncture, intravenous cannulation and painful injections in children. Even though its efficacy it's well established, most of the published trials did not compare Buzzy with other interventions, so that little data are available about its usefulness compared with other distractions techniques.\n\nHand-held computers are reusable tools, which offer a technological-based active distraction. There is evidence supporting their used during painful procedures such as venipuncture and a recent published study showed that hand-held computer distraction was as effective as nurse-led passive distraction techniques in children.\n\nThe aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in pain relief during venipuncture."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children from 4 to 12 years of age needing venipuncture\n\nExclusion Criteria:\n\n* the presence of damage, denuded or broken skin in the site of Buzzy application;\n* use of topical, enteral or parenteral analgesics within eight hours before enrolment;\n* the presence of cognitive impairment or the inability to report pain verbally;\n* the presence of chronic disease, included epilepsy, or of diseases associated with cold hypersensitivity (i.e., sickle cell anaemia, Raynaud's disease)."}, 'identificationModule': {'nctId': 'NCT02969902', 'briefTitle': 'Buzzy Distraction During Venipuncture', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Burlo Garofolo'}, 'officialTitle': 'Randomized Controlled Trial to Compare Buzzy and Hand-held Computer Distraction for Pain Control in Children Underwent Venipuncture.', 'orgStudyIdInfo': {'id': 'RC 19/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buzzy® device', 'description': 'The Buzzy® device is applied just above the selected site of the venipuncture; an ice pack is attached under the device; the device is turned on and after 15 second the venipuncture is made.', 'interventionNames': ['Device: Buzzy® device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hand-held computer', 'description': 'Using an hand-held computer, children start to play with an age-appropriate videogame three minutes before the procedure. They continue to play during the venipuncture.', 'interventionNames': ['Device: Hand-held computer']}], 'interventions': [{'name': 'Buzzy® device', 'type': 'DEVICE', 'armGroupLabels': ['Buzzy® device']}, {'name': 'Hand-held computer', 'type': 'DEVICE', 'armGroupLabels': ['Hand-held computer']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Egidio Barbi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS Burlo Garofolo'}, {'name': 'Franca Crevatin, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS Burlo Garofolo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Clinical Epidemiology and Public Health Research Unit', 'investigatorFullName': 'Luca Ronfani', 'investigatorAffiliation': 'IRCCS Burlo Garofolo'}}}}