Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT03693469
Status:
UNKNOWN
Last Update Posted:
2019-01-18
First Post:
2018-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-16', 'studyFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2018-09-30', 'lastUpdatePostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain using the Faces Pain Scale - Revised', 'timeFrame': 'Pain is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete.', 'description': 'Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2.'}], 'secondaryOutcomes': [{'measure': 'Anxiety using the Venham Situational Anxiety Score', 'timeFrame': 'Anxiety is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete.', 'description': 'Level of Situational Anxiety as reported by children using the Venham Situational Anxiety Score. This scale includes 8 sets of 2 images of children which represent differing levels of anxiety. Children point to the child that best represents them in that instance. In each set of 2 images of children, one represents greater anxiety (scored as 1) and one represents lesser anxiety (scored as 0). The points from each set of images are totaled. The minimum score is 0 (least anxious) and maximum score is 8 (most anxious).'}, {'measure': 'Patient Satisfaction determined by Global Rating Scale', 'timeFrame': 'Satisfaction question is reported by children immediately following completion of the immunization (within 5 minutes post immunization)', 'description': 'Satisfaction from the procedure is determined by asking 4 questions on a global rating scale. This scale goes from 0-10 where 0 represents "not very much" and 10 represents "very much." Questions are developed from previous virtual reality research. "Overall, how satisfied are you with pain management during plastic surgery?" "Overall, how satisfied are you with anxiety management during plastic surgery?" "To what extent did you feel like you went into the virtual world?" "How much fun did you have while playing in the virtual world?" These questions will be analyzed individually not summed.'}, {'measure': 'Medication Dose', 'timeFrame': 'These will be recorded during the procedure and immediately following the procedure using the patient chart', 'description': 'How much topical or local anesthetics are used and when they are used (24 hour time); how much sedatives are used and when they are used (24 hour time); how much analgesics are used and when they are used (24 hour time).'}, {'measure': 'Length of time of procedure', 'timeFrame': 'This will be documented during the procedure', 'description': 'Time in minutes from readiness for procedure (availability of child, staff and equipment) until completion of procedure (healthcare practitioner does not need to touch the patient anymore)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Pain', 'Anxiety'], 'conditions': ['Vaccination']}, 'descriptionModule': {'briefSummary': "Children need routine immunizations which can be a painful procedure associated with pain and anxiety. This is particularly true of children visiting the children's hospital to visit relatives during flu season. No topical anesthetic or oral analgesia is commonly used.\n\nVirtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.\n\nThis study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while receiving immunizations. Investigators will measure pain, anxiety and satisfaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children age 6 to 16 years\n2. Patients arriving to the immunization clinic for immunization.\n3. Parents will sign a consent form and children will sign an assent form\n\nExclusion Criteria:\n\n1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)\n2. Facial features or injury prohibiting wearing the VR goggles\n3. VR system may interfere with immunization'}, 'identificationModule': {'nctId': 'NCT03693469', 'briefTitle': 'Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children', 'orgStudyIdInfo': {'id': 'H18-01851'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality', 'description': 'Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during immunization.', 'interventionNames': ['Device: Virtual Reality']}, {'type': 'NO_INTERVENTION', 'label': 'Control (Standard-of-Care)', 'description': 'Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.'}], 'interventions': [{'name': 'Virtual Reality', 'type': 'DEVICE', 'description': 'Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.', 'armGroupLabels': ['Virtual Reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ran D Goldman, MD', 'role': 'CONTACT', 'email': 'rgoldman@cw.bc.ca', 'phone': '604-875-2000'}], 'facility': "BC Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Ran Goldman, MD', 'role': 'CONTACT', 'email': 'rgoldman@cw.bc.ca', 'phone': '604-875-2345', 'phoneExt': '7333'}], 'overallOfficials': [{'name': 'Ran Goldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital", 'investigatorFullName': 'Ran Goldman', 'investigatorAffiliation': 'University of British Columbia'}}}}