Nctid:
NCT06615245
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Each participant will eventually get to try virtual reality, but participants will not be informed that some people receive a more immersive virtual reality than other people. In other words, participants will remain blind to the high tech vs. Low tech VR manipulation."}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"mixed factorial design"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>48}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-11", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-11", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Difficulty performing the task and difficulty concentrating", "timeFrame"=>"immediately after each 2 minute session", "description"=>"subjective ratings of difficulty performing the simple attention task"}], "primaryOutcomes"=>[{"measure"=>"accuracy on an attention demanding cognitive test", "timeFrame"=>"responses will be made concurrently with VR vs. during No VR during 2 minute sessions", "description"=>"Number of correct responses on a divided attention task"}], "secondaryOutcomes"=>[{"measure"=>"presence ratings", "timeFrame"=>"measured immediately after each two minute VR session.", "description"=>"Graphic rating scale measures of patients illusion of \"being there\" in virtual reality."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["virtual reality", "distraction"], "conditions"=>["Distraction"]}, "descriptionModule"=>{"briefSummary"=>"Brief Summary\n\nUsing a randomized between group, mixed factorial, double blind design with healthy volunteers, this study will measure how much Virtual Reality (VR) reduces performance on a simple attention demanding task during No VR vs. Low Tech VR, vs. High Tech VR.\n\nThe primary aim is to explore whether a highly immersive VR system makes VR significantly more attention demanding/distracting, compared to a less immersive VR system, vs. No VR.", "detailedDescription"=>"Healthy college student volunteers will participate in a mixed factorial randomized controlled trial studying attention using a divided attention paradigm.\n\nGroup 1 will perform a simple attention demanding task during No VR for 2 minutes.\n\nand they will perform the attention demanding task again during No VR for 2 minutes, again.\n\nGroup 2 will perform a simple attention demanding task during No VR for 2 minutes and they will perform the attention demanding task again during Low Tech VR for 2 minutes.\n\nGroup 3 will perform a simple attention demanding task during No VR for 2 minutes and they will then perform the attention demanding task again during High Tech VR for 2 minutes."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Currently enrolled in a course at the University of Washington Psychology Dept., participating in the University of Washington (UW) Psychology subject pool\n* Able to read, write and comprehend English\n* Able to complete study measures\n* Willing to follow our UW approved instructions\n* 18 years of age or older\n\nExclusion Criteria:\n\n* People who have already previously participated in this same study (e.g., last quarter) are not eligible to participate again.\n* Not enrolled in a course at the University of Washington Psychology Dept., not participating in the UW Psychology subject pool\n* Not be able to read, write and comprehend English\n* Younger than 18 years of age.\n* Not capable of completing measures\n* Not capable of indicating pain intensity,\n* Not capable of filling out study measures,\n* Extreme susceptibility to motion sickness,\n* Seizure history,\n* Unusual sensitivity or lack of sensitivity to pain,\n* Sensitive skin,\n* Sensitive feet\n* Migraines\n* Diabetes"}, "identificationModule"=>{"nctId"=>"NCT06615245", "briefTitle"=>"Measuring Attention During Immersive Virtual Reality Distraction", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Washington"}, "officialTitle"=>"A Magic Bowl Low Tech vs. High Tech Immersive Virtual Reality Distraction", "orgStudyIdInfo"=>{"id"=>"UWashington"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"PLACEBO_COMPARATOR", "label"=>"Group 1 No VR", "description"=>"Group 1, participants will perform a simple attention demanding task during No VR for 2 minutes, and with no VR again for another 2 minutes. They will also rate how distracted they were and how hard it was to concentrate during each 2 minute task.", "interventionNames"=>["Behavioral: Group 1: No VR"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group 2 Low Tech VR", "description"=>"Group 2, participants will perform a simple attention demanding task during No VR for 2 minutes, and again during a Low Tech Virtual Reality game distraction. They will also rate how distracted they were and how hard it was to concentrate during each 2 minute task.", "interventionNames"=>["Behavioral: Group 2: Low Tech VR game"]}, {"type"=>"EXPERIMENTAL", "label"=>"Group 3 High Tech VR", "description"=>"Group 3, participants will perform a simple attention demanding task during No VR for 2 minutes, and again during a High Tech Virtual Reality game distraction. They will also rate how distracted they were and how hard it was to concentrate during the 2 minute tasks.", "interventionNames"=>["Behavioral: Group 3: High Tech VR game"]}], "interventions"=>[{"name"=>"Group 1: No VR", "type"=>"BEHAVIORAL", "description"=>"No VR distraction", "armGroupLabels"=>["Group 1 No VR"]}, {"name"=>"Group 2: Low Tech VR game", "type"=>"BEHAVIORAL", "description"=>"a Low Tech VR game distraction", "armGroupLabels"=>["Group 2 Low Tech VR"]}, {"name"=>"Group 3: High Tech VR game", "type"=>"BEHAVIORAL", "description"=>"a High Tech VR game distraction", "armGroupLabels"=>["Group 3 High Tech VR"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Hunter G. Hoffman, Ph.D", "role"=>"CONTACT", "email"=>"hunthoff9@gmail.com", "phone"=>"206 601-5090"}], "overallOfficials"=>[{"name"=>"Hunter G Hoffman, Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Washington"}]}, "ipdSharingStatementModule"=>{"timeFrame"=>"data set and data dictionary will be available indefinitely, beginning when the paper is officially published", "ipdSharing"=>"YES", "description"=>"de-identified individual data regarding participants gender, age, their accuracy on the simple attention task, and subjective ratings of difficulty performing the simple attention task, will be available upon to researchers who provide a methodologically sound proposal", "accessCriteria"=>"Researchers who provide a methodologically sound proposal (e.g, for meta-analysis)."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hunter Hoffman", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Sr. Research Scientist", "investigatorFullName"=>"Hunter Hoffman", "investigatorAffiliation"=>"University of Washington"}}}}
