Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
Study NCT ID:
NCT06712368
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-02
First Post:
2024-11-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality on Pain, Arterial Blood Gases and Functional Capacity in Children After Open Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2024-11-24', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '1 hour /session 1 time / day for 5 consecutive days', 'description': 'Pain assessment by Wong-Baker faces scale:'}, {'measure': 'arterial blood gases', 'timeFrame': '1 hour /session 1 time / day for 5 consecutive days', 'description': 'Arterial Blood Gases Analysis to detect blood gases'}, {'measure': 'functional capacity', 'timeFrame': '1 hour /session 1 time / day for 5 consecutive days', 'description': 'The Six-Minute Walk Test (6MWT) for assessment functional capacity'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['virtual reality, heart surgery'], 'conditions': ['Children After Open Heart Surgery']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to investigate:\n\n* The effect of virtual reality on pain in children after open heart surgery,\n* The effect of virtual reality on arterial blood gases in children after open heart surgery,\n* The effect of virtual reality on functional capacity in children after open heart surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders will be included.\n* Their age range from 6 to 12 years.\n* Children after open heart surgery ( phase I cardiac rehabilitation).\n\nExclusion Criteria:\n\nThe children have one or more of the following will be excluded:\n\n* Any child Suffering from any other chronic congenital diseases.\n* Severe visual or auditory problems.\n* Neurological problems.\n* Vertigo problems.\n* Post surgical hemorrhage.\n* Post surgical arrhythmia.'}, 'identificationModule': {'nctId': 'NCT06712368', 'briefTitle': 'Effect of Virtual Reality on Pain, Arterial Blood Gases and Functional Capacity in Children After Open Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Virtual Reality on Pain, Arterial Blood Gases and Functional Capacity in Children After Open Heart Surgery', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005353'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Designed cardiac physical therapy program ( study group )', 'description': 'Designed cardiac physical therapy program', 'interventionNames': ['Other: Designed cardiac physical therapy program']}, {'type': 'EXPERIMENTAL', 'label': 'virtual reality group (study group)', 'description': 'virtual reality glasses Designed cardiac physical therapy program applied through virtual reality glasses for study group', 'interventionNames': ['Device: virtual reality glasses']}], 'interventions': [{'name': 'virtual reality glasses', 'type': 'DEVICE', 'otherNames': ['Experimental: study group'], 'description': 'Designed cardiac physical therapy program applied through virtual reality glasses for study group', 'armGroupLabels': ['virtual reality group (study group)']}, {'name': 'Designed cardiac physical therapy program', 'type': 'OTHER', 'description': 'Designed cardiac physical therapy program without virtual reality glasses', 'armGroupLabels': ['Designed cardiac physical therapy program ( study group )']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'National heart institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator at Department of Pediatrics, Faculty of Physical Therapy, Cairo University', 'investigatorFullName': 'Aya Mamdouh Abdelmoaty Abdelaal', 'investigatorAffiliation': 'Cairo University'}}}}