Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-31 @ 11:28 PM
Study NCT ID:
NCT01952106
Status:
COMPLETED
Last Update Posted:
2014-12-08
First Post:
2013-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Distraction on Pain and Distress During Venepuncture in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-04', 'studyFirstSubmitDate': '2013-09-17', 'studyFirstSubmitQcDate': '2013-09-24', 'lastUpdatePostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Visual Analogue pain Scale will be used to evaluate children's pain perception", 'timeFrame': 'approximately 15 mins during venepuncture process', 'description': "monitor the children's oxygen saturation and pain scale."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['venepuncture', 'distraction', 'distress'], 'conditions': ['Hospitalism in Children', 'Pain']}, 'descriptionModule': {'briefSummary': "The main purpose of this study is Investigating the effectiveness of distraction by evaluating the children's perception of pain during venepuncture."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5-7 years old\n* understanding numeral\n\nExclusion Criteria:\n\n* mental retard and can not nuderstand numeral'}, 'identificationModule': {'nctId': 'NCT01952106', 'briefTitle': 'Effects of Distraction on Pain and Distress During Venepuncture in Children', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effects of Distraction on Pain and Distress During Venepuncture in Children', 'orgStudyIdInfo': {'id': '201305092RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'distraction', 'description': "use the computer game to distract children's pain and anxiety during venepuncture", 'interventionNames': ['Other: play computer game']}], 'interventions': [{'name': 'play computer game', 'type': 'OTHER', 'armGroupLabels': ['distraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital'}], 'overallOfficials': [{'name': 'chiying Tseng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}