Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
Study NCT ID:
NCT04349150
Status:
COMPLETED
Last Update Posted:
2021-12-20
First Post:
2020-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chung.daniel@mgh.harvard.edu', 'phone': '6177263544', 'title': 'Daniel C. Chung, MD', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9 months', 'description': 'There were no adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Virtual Reality', 'description': 'Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics\n\nVirtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Reality', 'description': 'Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics\n\nVirtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Measured as (x/n) \\* 100, where x = number of participants who completed colonoscopy using virtual reality and no pharmacological rescue, and n = total number of participants who initiated colonoscopy using virtual reality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Cecal Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Reality', 'description': 'Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics\n\nVirtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Number of Participants with Cecal Intubation using virtual reality and no pharmacological sedation. Measured as x/n, where x = number of participants in whom cecal intubation is achieved when participant is using virtual reality and no pharmacological sedation, and n = total number of participants who initiated colonoscopy using virtual reality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participant-reported Pain and Discomfort Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Reality', 'description': 'Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics\n\nVirtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Discomfort', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'participants will rate their pain and discomfort on a numeric rating scale of 1-10 (1 = no pain/discomfort, 10 = extreme pain/discomfort)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The 26 participants who did not request medication during colonoscopy.'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Reality', 'description': 'Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics\n\nVirtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '2.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Participants will rate their satisfaction with their experience using virtual reality during colonoscopy on a numeric rating scale of 1-10 (1 = not satisfied, 10 = extremely satisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The 26 participants who did not request medication during colonoscopy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Would Undergo Future Colonoscopies Using Virtual Reality and no Pharmacological Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Reality', 'description': 'Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics\n\nVirtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Maybe', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Participants will rate their willingness to undergo future colonoscopies using virtual reality and no pharmacological sedation as "Yes," "Maybe," or "No."', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The 26 participants who did not request medication during colonoscopy.'}, {'type': 'SECONDARY', 'title': 'Endoscopist Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Reality', 'description': 'Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics\n\nVirtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Endoscopists will rate their satisfaction performing colonoscopy on participants using virtual reality instead of pharmacological sedation on a numeric rating scale of 1-10 (1 = not satisfied, 10 = extremely satisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The 26 participants who did not request medication during colonoscopy.'}, {'type': 'SECONDARY', 'title': 'Number of Endoscopies Following Which Endoscopists Indicated Willingness to Incorporate Virtual Reality Into Regular Colonoscopy Practice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Reality', 'description': 'Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics\n\nVirtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Yes, but I would use virtual reality as an adjunct therapy rather than a standalone therapy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Endoscopists will indicate whether they would incorporate virtual reality into their regular colonoscopy practice by selecting one of the following:\n\n* yes\n* no\n* yes, but I would use virtual reality as an adjunct therapy rather than a standalone therapy', 'unitOfMeasure': 'Endoscopies', 'reportingStatus': 'POSTED', 'populationDescription': 'The four endoscopists participating in the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Virtual Reality', 'description': 'Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics\n\nVirtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'All individuals scheduled for screening/surveillance colonoscopy who had previously undergone more than one colonoscopy under conscious sedation and were patients of any of four endoscopists at our institution were invited to participate.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Virtual Reality', 'description': 'Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics\n\nVirtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '8.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medical history potentially impacting exam difficulty', 'classes': [{'categories': [{'title': 'Abdominal/pelvic surgery', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Tortuous colon', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'None', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-01', 'size': 137912, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-24T15:20', 'hasProtocol': True}, {'date': '2021-09-01', 'size': 490466, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-24T15:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-04', 'studyFirstSubmitDate': '2020-02-18', 'resultsFirstSubmitDate': '2021-09-24', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-04', 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Measured as (x/n) \\* 100, where x = number of participants who completed colonoscopy using virtual reality and no pharmacological rescue, and n = total number of participants who initiated colonoscopy using virtual reality.'}, {'measure': 'Number of Participants With Cecal Intubation', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Number of Participants with Cecal Intubation using virtual reality and no pharmacological sedation. Measured as x/n, where x = number of participants in whom cecal intubation is achieved when participant is using virtual reality and no pharmacological sedation, and n = total number of participants who initiated colonoscopy using virtual reality.'}], 'secondaryOutcomes': [{'measure': 'Participant-reported Pain and Discomfort Levels', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'participants will rate their pain and discomfort on a numeric rating scale of 1-10 (1 = no pain/discomfort, 10 = extreme pain/discomfort)'}, {'measure': 'Participant Satisfaction', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Participants will rate their satisfaction with their experience using virtual reality during colonoscopy on a numeric rating scale of 1-10 (1 = not satisfied, 10 = extremely satisfied).'}, {'measure': 'Number of Participants Who Would Undergo Future Colonoscopies Using Virtual Reality and no Pharmacological Sedation', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Participants will rate their willingness to undergo future colonoscopies using virtual reality and no pharmacological sedation as "Yes," "Maybe," or "No."'}, {'measure': 'Endoscopist Satisfaction', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Endoscopists will rate their satisfaction performing colonoscopy on participants using virtual reality instead of pharmacological sedation on a numeric rating scale of 1-10 (1 = not satisfied, 10 = extremely satisfied).'}, {'measure': 'Number of Endoscopies Following Which Endoscopists Indicated Willingness to Incorporate Virtual Reality Into Regular Colonoscopy Practice', 'timeFrame': 'This data will be collected within 60 minutes of completion of the colonoscopy', 'description': 'Endoscopists will indicate whether they would incorporate virtual reality into their regular colonoscopy practice by selecting one of the following:\n\n* yes\n* no\n* yes, but I would use virtual reality as an adjunct therapy rather than a standalone therapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual reality'], 'conditions': ['Colonoscopy']}, 'descriptionModule': {'briefSummary': 'Colonoscopy patients will be fitted with a virtual reality head-mounted display, and virtual experiences will be initiated prior to colonoscope insertion. Colonoscopy will be initiated without standard sedatives and narcotics. The colonoscopy will proceed with the subject using virtual reality distraction instead of pharmacological sedation for as long as s/he would like. Standard sedatives and narcotics will be administered upon participant request at any time during the procedure. Questionnaires will be administered to the subject and the endoscopist after each procedure to assess the acceptability of use of virtual reality in the colonoscopy setting.', 'detailedDescription': 'This study aims to assess whether virtual reality is an acceptable alternative to pharmacological sedation during colonoscopy. Past research has shown that in order to fully experience pain, one must pay attention to it. Virtual reality has been shown to help mitigate pain by providing distraction from the painful stimulus.\n\nIn this study, participants undergo screening or surveillance colonoscopy under virtual reality distraction.\n\nIndividuals who are scheduled for a routine screening or surveillance colonoscopy and have had at least one prior colonoscopy under conscious sedation are eligible to participate. Those who give written, informed consent are fitted with and oriented to a virtual reality head-mounted display. The subject is then prepped for the colonoscopy by a registered nurse per institution protocol. This includes placement of an intravenous line.\n\nWritten consent is obtained for colonoscopy with medication by the performing endoscopist. The patient is again fitted with the virtual reality head-mounted display and virtual experiences are initiated. The endoscopist performs the colonoscopy with the subject using virtual reality distraction instead of pharmacological sedation for as long as the subject likes. Standard sedatives and narcotics will be administered by a registered nurse upon participant request at any time during the procedure.\n\nFollowing the procedure, participants and endoscopists complete a questionnaire about their subjective experience with virtual reality during colonoscopy. The research coordinator fills out a case report form for each subject with information about the procedure including length, colonoscopy findings, and complications as noted by the endoscopist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (18 years or older)\n* Scheduled for screening or surveillance colonoscopy\n* Has undergone at least 1 prior colonoscopy under conscious sedation\n\nExclusion Criteria:\n\n* Children (\\<18 years)\n* Scheduled to undergo colonoscopy under general anesthesia\n* Scheduled to undergo colonoscopy with no sedation\n* First-time colonoscopy patients\n* Scheduled for colonoscopy to assess symptoms or pre-existing disease'}, 'identificationModule': {'nctId': 'NCT04349150', 'briefTitle': 'Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Pilot Study of Virtual Reality Technology as an Alternative to Pharmacological Sedation During Colonoscopy', 'orgStudyIdInfo': {'id': '2018P001618'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality', 'description': 'Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics', 'interventionNames': ['Device: Virtual reality']}], 'interventions': [{'name': 'Virtual reality', 'type': 'DEVICE', 'description': 'Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy', 'armGroupLabels': ['Virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Daniel C Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Daniel C Chung, MD, Director of High-Risk GI Cancer Clinic', 'investigatorFullName': 'Daniel C Chung', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}