Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-11 @ 5:24 PM
Study NCT ID:
NCT06504602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-18
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Elimination and Anxiety Control Through Experiential Virtual Reality
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': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement', 'timeFrame': '5 minutes before, immediately after procedure', 'description': 'Pain score on Faces Pain Scale - Revised will be assessed 5 minutes before and immediately after procedure. The minimum score is 0, and the maximum score is 10. Higher scores correlate to a worse outcome (more pain).'}], 'secondaryOutcomes': [{'measure': 'Mean Change from Baseline in Anxiety Scores on Visual Analog Scale after IV Placement', 'timeFrame': '5 minutes before, immediately after procedure', 'description': 'Anxiety score on Visual Analog Scale will be assessed 5 minutes before and immediately after procedure. The minimum score is 0, and the maximum score is 100. Higher scores correlate to a worse outcome (more anxiety).'}, {'measure': 'Mean Change from Baseline in Heart Rate after IV Placement', 'timeFrame': '5 minutes before, during, and immediately after procedure', 'description': 'Heart Rate will be measured 5 minutes before, during, and immediately after procedure'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Procedural Pain', 'Procedural Anxiety']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. The main question\\[s\\] it aims to answer \\[is/are\\]:\n\n* Will active virtual reality reduce pain score on Faces Pain Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?\n* Will active virtual reality reduce anxiety score on Visual Analog Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?\n\nIf there is a comparison group: Researchers will compare active group to passive group and standard of care.\n\nParticipants will randomized into active virtual reality, passive virtual reality or standard of care arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children and adolescents 8-21 years old undergoing IV placement .\n\n * Ability to understand study procedures and to comply with them for the entire length of the study.\n * Participants and caregiver speaking English or Spanish.\n\nExclusion Criteria:\n\n* Participants with psychiatric, developmental delay, visual or auditory deficits that would interfere with virtual reality gameplay (decision based on treating clinicians' evaluation).\n\n * Participants receiving narcotics, opioids, or anxiolytics 8 hours prior (Tylenol and ibuprofen do not count).\n * Participants with pain so significant that consent/assent is not possible (decision based on treating clinician evaluation).\n * Critically ill Participants (ESI 1)."}, 'identificationModule': {'nctId': 'NCT06504602', 'briefTitle': 'Pain Elimination and Anxiety Control Through Experiential Virtual Reality', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'Pain Elimination and Anxiety Control Through Experiential Virtual Reality', 'orgStudyIdInfo': {'id': 'CHLA-24-00171'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Virtual Reality', 'description': 'Within the active virtual reality group virtual environment, participants will play the game Bearblast using Oculus Go Headset for patients 8-21 years old. In BearBlast, participants travel on a pre-set path through an interactive environment.', 'interventionNames': ['Device: Active Virtual Reality']}, {'type': 'EXPERIMENTAL', 'label': 'Passive Virtual Reality', 'description': 'Within the passive virtual reality group virtual environment and age appropriate movie.', 'interventionNames': ['Device: Passive Virtual Reality']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Participants will receive standard of care distraction methods.'}], 'interventions': [{'name': 'Active Virtual Reality', 'type': 'DEVICE', 'description': 'Active virtual reality group will play a game through a virtual environment.', 'armGroupLabels': ['Active Virtual Reality']}, {'name': 'Passive Virtual Reality', 'type': 'DEVICE', 'description': 'Passive virtual reality group will watch a movie through a virtual environment.', 'armGroupLabels': ['Passive Virtual Reality']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Matan Paret, MD', 'role': 'CONTACT', 'email': 'mparet@chla.usc.edu', 'phone': '3233764793'}], 'overallOfficials': [{'name': 'Matan Paret, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Matan Paret', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}