Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-25 @ 1:25 AM
Study NCT ID:
NCT04081935
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2019-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Distraction Using VR for Children During IV in an Emergency Department
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-06', 'studyFirstSubmitDate': '2019-09-01', 'studyFirstSubmitQcDate': '2019-09-06', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The degrees of pain experienced by the children.', 'timeFrame': 'The posttests 8 min after the tourniquets were worn.', 'description': 'Measurement of pain using the Wong-Baker FACES Pain Rating Scale(WBFPS). The scale contains six cartoon faces showing pain ratings of 0-10, which are, from left to right, no pain (0), a little pain (2), mild pain (4), average pain (6), severe pain (8), and excruciating pain (10).The children, primary caregivers, and nurses were asked to select the faces that best described the pain levels experienced by the children receiving intravenous injections; the pain levels were subsequently converted into numerical values .'}, {'measure': 'The degrees of fear experienced by the children.', 'timeFrame': 'The posttests 8 min after the tourniquets were worn.', 'description': 'Measurement of fear using the Choldren Fear Scale(CFS).The scale consists of five cartoon faces showing fear ratings of 0-4, which were no fear (0), a little fear (1), some fear (2), very fear(3) and extreme fear (4). The children, primary caregivers, and nurses were asked to select the faces that best described the fear levels of the children receiving intravenous injections. The pain levels were subsequently converted into numerical values.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['school-age children, emergency treatment, intravenous placement, virtual reality, pain, fear'], 'conditions': ['Pain', 'Fear']}, 'referencesModule': {'references': [{'pmid': '31715039', 'type': 'DERIVED', 'citation': 'Chen YJ, Cheng SF, Lee PC, Lai CH, Hou IC, Chen CW. Distraction using virtual reality for children during intravenous injections in an emergency department: A randomised trial. J Clin Nurs. 2020 Feb;29(3-4):503-510. doi: 10.1111/jocn.15088. Epub 2019 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'Exploring the use of virtual reality as a distracting intervention strategy for school-age children to receive intravenous placement in emergency department, and further understand the effectiveness of reducing pain and fear during the invasive procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children ages 7-12\n* Children who were clearly conscious\n* Children who agreed and were required to receive intravenous injections after physicians' diagnoses\n* Children and their primary caregivers who could communicate in Mandarin or Taiwanese\n* Children and their primary caregivers who could read Chinese that agreed to participate in this study and sign written consent forms\n\nExclusion Criteria:\n\n* Children with developmental delay, epilepsy, or heart diseases\n* Children undergoing chemotherapy; children who were visually or hearing impaired\n* Children who were nearsighted with more than 8.0 diopters or farsighted with 5.0 diopters\n* Children who had sustained head trauma in the past month\n* Children who were confirmed to be obese according to the recommended body mass index values for children and adolescents\n* Children who required blood transfusions and blood preparation to be performed according to physician diagnoses\n* Children who received two or more intravenous injections and had their blood drawn only one time"}, 'identificationModule': {'nctId': 'NCT04081935', 'briefTitle': 'Distraction Using VR for Children During IV in an Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'Distraction Using Virtual Reality for Children During Intravenous Injections in an Emergency Department: A Randomized Trial', 'orgStudyIdInfo': {'id': '2017B002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduce pain and fair', 'description': 'To determine whether the virtual reality as a distracting intervention could reduce pain and fear in school-age children receiving intravenous injections at an emergency department.', 'interventionNames': ['Device: Virtual Reality']}, {'type': 'NO_INTERVENTION', 'label': 'Compared', 'description': 'Normal treatment'}], 'interventions': [{'name': 'Virtual Reality', 'type': 'DEVICE', 'description': 'virtual reality (VR) as a distracting intervention could reduce pain and fear during an IV placement for school-age children in the emergent department.', 'armGroupLabels': ['Reduce pain and fair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Yang-Ming University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}