Nctid:
NCT06236386
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015179", "term"=>"Colorectal Neoplasms"}], "ancestors"=>[{"id"=>"D000007414", "term"=>"Intestinal Neoplasms"}, {"id"=>"D000005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000003108", "term"=>"Colonic Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000012002", "term"=>"Rectal Diseases"}], "browseLeaves"=>[{"id"=>"M17890", "name"=>"Colorectal Neoplasms", "asFound"=>"Colorectal Cancer", "relevance"=>"HIGH"}, {"id"=>"M10448", "name"=>"Intestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"OTHER", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"This study will use a convergent mixed methods (QUAN + QUAL) design to measure the reach, effectiveness, adoption, implementation, and maintenance of translating VR evidence into practice.\n\nQualitative data will be collected after the colonoscopy procedure by using a customized satisfaction survey, measuring the experience and satisfaction of patients and clinicians. Six months after launching this study, clinicians will be surveyed about their continuation of using VR during colonoscopy procedures.\n\nIndividual quantitative and qualitative results will be merged initially through a convergent data analysis integration strategy that will compare both strands side by side. This strategy contributes to the overall interpretation of the findings."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>120}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-06", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2023-10-04", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-03", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Level of Pain", "timeFrame"=>"10 months", "description"=>"Numeric Rating Scale: 0 (No Pain) to 10 (worst possible pain)"}, {"measure"=>"Ramsay Score", "timeFrame"=>"10 months", "description"=>"Ramsay score: 1 to 6 (1- Awake; agitated or restless or both to 6-sleep; Asleep; no response to glabellar tap or loud auditory stimulus)"}, {"measure"=>"Medication Administration", "timeFrame"=>"10 months", "description"=>"Medications administered: opioids, benzodiazepines, other medication"}, {"measure"=>"Procedure Length", "timeFrame"=>"10 months", "description"=>"Length of the procedure: minutes"}, {"measure"=>"Recovery Time", "timeFrame"=>"10 months", "description"=>"Recovery time: minutes"}, {"measure"=>"Preferred Video Type", "timeFrame"=>"10 months", "description"=>"VR video type: video content (ocean, nature, space)"}, {"measure"=>"VR Experience satisfaction", "timeFrame"=>"10 months", "description"=>"VR Experience satisfaction questions: 5-point Likert scale (1-Strongly disagree - 5 Strongly agree)"}, {"measure"=>"Clinician Feedback", "timeFrame"=>"10 months", "description"=>"Clinician Open-ended question about what would be changed from the process"}], "secondaryOutcomes"=>[{"measure"=>"Length of recovery", "timeFrame"=>"10 months", "description"=>"Length of time in Recovery (minutes)"}, {"measure"=>"Adverse Events", "timeFrame"=>"10 months", "description"=>"Frequency of adverse events (name and number)"}, {"measure"=>"Medication Use", "timeFrame"=>"10 months", "description"=>"Medication administration comparison between two groups"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Colorectal Cancer"]}, "descriptionModule"=>{"briefSummary"=>"Colorectal cancer (CRC) in the United States (US) is the fourth leading cause of cancer- related deaths. In Puerto Rico (PR), the incidence and mortality rate of CRC is higher (41% and 14%) in comparison to the mainland US (38% and 13%). To reduce mortality, receiving a colonoscopy is considered the gold standard for early detection. Yet Puerto Ricans are less likely to adhere to this recommendation than individuals in the mainland US (52% vs. 65%).\n\nFear of acute pain may contribute to this reluctance despite the administration of sedation and analgesia during the procedure. The American Society for Gastrointestinal Endoscopy's recommended current standard of practice is to administer opioids and benzodiazepines to achieve minimal and/or moderate sedation during a colonoscopy procedure. Because patients still have conscious awareness, adding an effective pain distraction tool, such a virtual reality (VR), to their pharmacological standard of care during this short procedure could improve outcomes through decreased opioid and anxiolytic administration.\n\nStrong evidence supports VR's effectiveness to distract patients from acute pain during brief medical procedures. To address this translational gap from research to clinical practice within a Hispanic oncology population receiving colonoscopies, an implementation science (IS) framework will be utilized to measure: reach, effectiveness, adoption, implementation, and maintenance. RE-AIM is an IS framework that systematically measures and supports sustainable adoption and implementation of evidence-based interventions into clinical practice. The purpose of this IS study will be to evaluate the translation of VR into clinical practice for patients during a CRC screening colonoscopy.", "detailedDescription"=>"The purpose of this study will be to evaluate the translation of VR into clinical practice for patients scheduled to receive a CRC screening through a colonoscopy. Findings from this study has widespread implications of translating VR technology to other patient populations and clinical settings during short procedures to improve outcomes. The specific aims will be to:\n\nAim 1. Determine the feasibility of implementing a VR distraction experience for patients during colonoscopy procedures using the RE-AlM framework. Using a mixed-methods approach, the investigators will evaluate participant participation (reach), opioid and benzodiazepines use, pain and sedation scores before, during, and after the procedure (effectiveness), acceptance of the VR experience (adoption), use of VR experience as intended (implementation), and continued long-term use of VR (maintenance) through quantitative and qualitative measurements.\n\nAim 2. Determine the costs and return on investment of implementing a VR experience for patients during colonoscopy procedures. The investigators will evaluate and compare the cost of the VR intervention and the rate of adverse events related to opioid administration to calculate return on investment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"21 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Scheduled to receive a colonoscopy procedure\n* 21 years of age or older\n* Ability to read and speak in Spanish.\n\nExclusion Criteria:\n\n* History of seizures\n* Balance disorder\n* Current infectious disease\n* Cognitive and visual impairments\n* Sedation intolerance\n* History of motion sickness."}, "identificationModule"=>{"nctId"=>"NCT06236386", "acronym"=>"VR", "briefTitle"=>"Virtual Reality During Colonoscopy Procedures", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Puerto Rico"}, "officialTitle"=>"Translating Virtual Reality Research Evidence Into Clinical Practice During Colonoscopy Procedures", "orgStudyIdInfo"=>{"id"=>"2023-05-102"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"OTHER", "label"=>"VR Experience", "description"=>"A VR headset will be loaned to patients to be immersed in a VR environment while undergoing their colonoscopy.", "interventionNames"=>["Other: VR Experience"]}], "interventions"=>[{"name"=>"VR Experience", "type"=>"OTHER", "description"=>"VR headset and video experience.", "armGroupLabels"=>["VR Experience"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Sherily Pereira-Morales, PhD, FAAN", "role"=>"CONTACT", "email"=>"sherily.pereira@upr.edu", "phone"=>"7877582525", "phoneExt"=>"2717"}, {"name"=>"Susan Birkhoff, PhD,RN", "role"=>"CONTACT", "email"=>"Susan.Birkhoff@ChristianaCare.org"}], "overallOfficials"=>[{"name"=>"Sherily Pereira, PhD, FAAN", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Puerto Rico, Medical Sciences Campus, School of Nursing"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Puerto Rico", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Sherily Pereira-Morales", "investigatorAffiliation"=>"University of Puerto Rico"}}}}
