Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT05135260
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2021-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063367', 'term': 'Virtual Reality Exposure Therapy'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-11', 'size': 1378695, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-11-08T17:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive or negative effect of Virtual Reality therapy on improving the experience of participants receiving chemotherapy', 'timeFrame': 'Approximately 12 months', 'description': 'Measured by the Positive and Negative Affect Scale (0=minimum to 5=maximum). Consisting of a number of words that describe different feelings and emotions. Patients are instructed to indicate to what extent they currently feel each of the feelings or emotions. Afterwards, patient responses are scored to produce a numerical positive affect score and a negative affect score.'}, {'measure': 'Measure the affect of Virtual Reality Therapy on improving stress', 'timeFrame': 'Approximately 12 months', 'description': 'Measured by stress level using the stress numerical rating'}, {'measure': 'Measure the affect of Virtual Reality Therapy on improving pain', 'timeFrame': 'Approximately 12 months', 'description': 'Measured by pain level using the pain numerical score (scale 0 (none) to 10 (worst)'}], 'secondaryOutcomes': [{'measure': 'Rate of cyber sickness (Virtual Reality Therapy Arm Only)', 'timeFrame': 'Approximately 12 months', 'description': 'Measured with the Fast MS Scale (FMS), a verbal rating scale ranging from zero (no sickness at all) to 20 (frank sickness).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Chemotherapy']}, 'descriptionModule': {'briefSummary': 'This study will investigate the ability of virtual reality to function as a novel distraction intervention and improve the experience of patients who are receiving chemotherapy in the infusion clinic.', 'detailedDescription': 'Objectives:\n\nPrimary Objective:\n\n\\- To deploy and evaluate virtual reality as an intervention for stress, pain, and negative affect\n\nSecondary Objective:\n\n\\- To evaluate cyber sickness and patient satisfaction related to the virtual reality treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At or above the age of 18\n* English Speaking\n* Diagnosed with cancer\n* No previous history of seizures, losses of awareness, or other symptoms linked to an epileptic condition\n* Not sensitive to motion sickness\n* Not currently experiencing any contagious conditions, infections, or diseases (particularly of the eyes, skin, or scalp)\n* Does not use a device to regulate heart rate or rhythm (such as a pacemaker)\n* Not taking antiarrhythmic medications\n* Not actively receiving radiopharmaceutical therapy\n\nExclusion:\n\n* To ensure that there is sufficient time to complete the virtual reality treatment, patients who are scheduled for visits for periods of less than one hour will not be included in this study. Additionally, patients must consent to participating in the study on the day of the experience.\n* Patients who are asleep prior to consenting will not be asked to participate in the study'}, 'identificationModule': {'nctId': 'NCT05135260', 'briefTitle': 'Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'The Effects of Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic', 'orgStudyIdInfo': {'id': 'VICC SUPP 2079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Therapy', 'description': 'Participants will watch videos for 11 minutes that will allow them to view nature, dinosaurs, animals, and human interactions in three dimension.', 'interventionNames': ['Behavioral: Virtual reality therapy', 'Behavioral: Questionnaires', 'Procedure: Measure heart rate', 'Behavioral: Cyber sickness measurement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'This group will not watch videos, but will continue with their normal routine as if nothing has changed.', 'interventionNames': ['Behavioral: Questionnaires', 'Procedure: Measure heart rate']}], 'interventions': [{'name': 'Virtual reality therapy', 'type': 'BEHAVIORAL', 'description': 'Participants will watch a video allowing them to view nature, dinosaurs, animals, and human interactions in three dimensions during a session lasting 11 minutes.', 'armGroupLabels': ['Virtual Reality Therapy']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': 'Questionnaires will be completed regarding stress, pain and affect', 'armGroupLabels': ['Control Group', 'Virtual Reality Therapy']}, {'name': 'Measure heart rate', 'type': 'PROCEDURE', 'description': 'To be measured prior to starting treatment and halfway through the 11 minute Video', 'armGroupLabels': ['Control Group', 'Virtual Reality Therapy']}, {'name': 'Cyber sickness measurement', 'type': 'BEHAVIORAL', 'description': 'To be measured using the fast motion sickness scale', 'armGroupLabels': ['Virtual Reality Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Cody Stansel, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cody Stansel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cody Stansel', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}