Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-27 @ 11:55 PM
Study NCT ID:
NCT05701566
Status:
UNKNOWN
Last Update Posted:
2023-04-10
First Post:
2023-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'pilot randomized controled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2023-01-26', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy.', 'timeFrame': '1 day', 'description': 'Questionnaire (1 - not satisfied at all, 5 - very satisfied)'}], 'secondaryOutcomes': [{'measure': 'Pain during the procedure', 'timeFrame': '1 day', 'description': 'Questionnaire (1- severe pain, 5 - no pain at all)'}, {'measure': 'polyp detection rate (PDR)', 'timeFrame': 'during colonoscopy procedure', 'description': 'number of polyps detected during colonoscopy'}, {'measure': 'Colonoscopy duration', 'timeFrame': 'during colonoscopy procedure', 'description': 'in minutes starting at insertion of the colonoscope to the anus until final withdrawal'}, {'measure': 'Post colonoscopy adverse events', 'timeFrame': '1 day', 'description': 'Questionnaire: Did you suffer from a general bad feeling after the test, including dizziness, nausea, abdominal pain (1 - no complaints at all, 5 - serious complaints)'}, {'measure': 'Time-to-return to daily activities (work, driving)', 'timeFrame': '1 day', 'description': 'hours'}, {'measure': 'Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit)', 'timeFrame': '1 day', 'description': 'overall time at the unit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Satisfaction']}, 'descriptionModule': {'briefSummary': 'A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination.', 'detailedDescription': 'VR is an attention-distracting technology via visual and auditory signals by a computer-generated virtual engulfing environment. This technology has already been used in a variety of medical conditions and previous studies have demonstrated the benefit of using it as an additional tool for pain relief and as a substitute to sedation in invasive procedure. In this study we examined the use of VR as a substitute for sedation in colonoscopy. In this randomized control study, 60 patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure. The primary outcome was the overall satisfaction of patients who underwent unsedated colonoscopy with VR headset compared with patients who underwent standard sedation colonoscopy. Pain during the procedure, PDR, colonoscopy duration, post colonoscopy adverse events, post colonoscopy recovery and time-to-return to daily functions and turnaround time at the endoscopy unit were secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult patients (≥18) with any elective indication for colonoscopy.\n\nExclusion Criteria:\n\n* known seizures' disorders, cognitive, visual or auditory impairment.\n* patients who were unable or unwilling to sign an informed consent.\n* Pregnant women."}, 'identificationModule': {'nctId': 'NCT05701566', 'briefTitle': 'Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy', 'orgStudyIdInfo': {'id': '8177-21-IV-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'virtual reality group', 'description': 'unsedated colonoscopy using virtual reality headset.', 'interventionNames': ['Device: virtual reality headset']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'colonoscopy with standard sedation', 'description': 'standard sedated colonoscopy.', 'interventionNames': ['Other: colonoscopy with standard sedation.']}], 'interventions': [{'name': 'virtual reality headset', 'type': 'DEVICE', 'description': 'use of virtual reality headset during colonoscopy as a substitute to sedation.', 'armGroupLabels': ['virtual reality group']}, {'name': 'colonoscopy with standard sedation.', 'type': 'OTHER', 'description': 'use of standard sedation during colonoscopy.', 'armGroupLabels': ['colonoscopy with standard sedation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Litwinsky', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ido Veisman, Dr.', 'role': 'CONTACT', 'email': 'ido.veisman@sheba.health.gov.il', 'phone': '+97235307072'}, {'name': 'Revital Dvir', 'role': 'CONTACT', 'email': 'revital.dvir@sheba.health.gov.il', 'phone': '+97235307072'}], 'facility': 'Gastroenterology department, Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Ido Veisman, Dr.', 'role': 'CONTACT', 'email': 'Ido.Veisman@sheba.health.gov.il', 'phone': '+97235307072', 'phoneExt': '7072'}, {'name': 'Revital Dvir, Mrs.', 'role': 'CONTACT', 'email': 'revital.dvir@sheba.health.gov.il', 'phone': '+97235307072'}], 'overallOfficials': [{'name': 'Ido Veisman, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}