Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-28 @ 5:34 AM
Study NCT ID:
NCT03745833
Status:
UNKNOWN
Last Update Posted:
2018-11-19
First Post:
2018-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2018-11-13', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal pain', 'timeFrame': '1 hour after meals', 'description': 'We will measure pre- and post-intervention pain scores using the validated Faces Pain Scale'}], 'secondaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': '1 hour after meals', 'description': 'We will measure pre- and post-intervention anxiety scores using the validated Hamilton Anxiety Scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eating Disorder', 'Anxiety', 'Abdominal Pain']}, 'descriptionModule': {'briefSummary': 'Adolescents and young adults with eating disorders undergoing refeeding on an inpatient unit often experience abdominal pain and anxiety either as a result of their medical condition or as an expected side effect of nutritional rehabilitation. The purpose of this study is to assess if VR (Virtual Reality) mindfulness therapy is more or as effective as the standard of care (supportive care such as aromatherapy, heat packs, distraction, and nausea bands) for treating and/or preventing anxiety and pain in patients with eating disorders during the re-nourishment process. The anticipated primary outcome will be reduction of abdominal pain and anxiety with utilization of this intervention.', 'detailedDescription': 'In this study, investigators hope to 1) assess acceptance of VR mindfulness among inpatient adolescents and young adults with eating disorders 2) assess effects of VR mindfulness on perceived abdominal pain and 3) determine the impact of VR mindfulness on anxiety scores.\n\nThis study is designed to test the feasibility, acceptability and effectiveness of VR mindfulness in patients as they undergo various medical and nutritional therapies to treat their conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients admitted to the inpatient medical unit for refeeding for malnutrition\n\nExclusion Criteria:\n\n* non-English speakers'}, 'identificationModule': {'nctId': 'NCT03745833', 'briefTitle': 'Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Adolescent and Young Adult Patients With Eating Disorders', 'orgStudyIdInfo': {'id': '47146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants will be shown a brief VR-based mindfulness intervention after meals.', 'interventionNames': ['Device: Virtual Reality Mindfulness']}], 'interventions': [{'name': 'Virtual Reality Mindfulness', 'type': 'DEVICE', 'description': 'Participating patients will be provided with a VR headset (pre-programmed with mindfulness content) after lunch for 15 minutes with supervision while on strict bedrest. The headset will be collected following the intervention. Patients are currently provided with a post-meal survey following all meals as part of the standard of care, and will complete the survey following the lunchtime intervention.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Megen Vo, MD', 'role': 'CONTACT', 'email': 'megenvo@stanford.edu', 'phone': '5182218601'}, {'name': 'Colleen Surmay, NP', 'role': 'CONTACT', 'email': 'csurmay@stanfordchildrens.org', 'phone': '6509884106'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Megen Vo', 'investigatorAffiliation': 'Stanford University'}}}}