Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
128 participants
INTERVENTIONAL
2022-05-17
2022-09-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Phase 1 - VR-BF BE
We are applying Behavioral Economics (BE)-based messaging and presentation strategies to patient recruitment and determining whether these strategies may enhance patient recruitment into a pediatric randomized clinical trial. Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.
Behavioral Economics (BE) recruitment strategies
Behavioral economics (BE), a method of economic analysis that applies psychological insights into human behavior to explain economic decision-making, has broad applicability and its techniques offer a novel way that may be applied to try to help enhance study recruitment and enrollment.
Biofeedback-based virtual reality (VR-BF)
Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.
Phase 1 - VR-BF Biological
A similar to BE-based recruitment video using a standard biological approach on teenagers' decision to enroll in a clinical study will be used as comparison. Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.
Biofeedback-based virtual reality (VR-BF)
Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.
Phase 2 - Manage My Pain BE
We are applying Behavioral Economics (BE)-based messaging and presentation strategies to patient recruitment and determining whether these strategies may enhance patient recruitment into a pediatric randomized clinical trial. Phase 2 will focus on patients that would be enrolled into the control arm of a clinical trial with a control intervention, Manage My Pain application.
Behavioral Economics (BE) recruitment strategies
Behavioral economics (BE), a method of economic analysis that applies psychological insights into human behavior to explain economic decision-making, has broad applicability and its techniques offer a novel way that may be applied to try to help enhance study recruitment and enrollment.
Manage My Pain
Commercially available and free app to track, analyze and monitor pain.
Phase 2 - Manage My Pain Biological
A similar to BE-based recruitment video using a standard biological approach on teenagers' decision to enroll in a clinical study will be used as comparison. Phase 2 will focus on patients that would be enrolled into the control arm of a clinical trial with a control intervention, Manage My Pain application.
Manage My Pain
Commercially available and free app to track, analyze and monitor pain.
Interventions
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Behavioral Economics (BE) recruitment strategies
Behavioral economics (BE), a method of economic analysis that applies psychological insights into human behavior to explain economic decision-making, has broad applicability and its techniques offer a novel way that may be applied to try to help enhance study recruitment and enrollment.
Biofeedback-based virtual reality (VR-BF)
Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.
Manage My Pain
Commercially available and free app to track, analyze and monitor pain.
Eligibility Criteria
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Inclusion Criteria
* Patients able to read, understand, and speak English
* Patients undergoing surgery requiring postoperative admission
* Patients undergoing surgery that requires narcotic administration
Exclusion Criteria
* Patients with history of developmental delay, uncontrolled psychiatric conditions, or neurological conditions (i.e., epilepsy, motion sickness, nausea/vomiting)
* History of severe vertigo or dizziness
* History of chronic pain
* Patients that use opioids or benzodiazepines chronically
* Patients with conditions that would preclude placement of a VR headset, including craniofacial abnormalities or undergoing surgeries of the head and neck.
12 Years
18 Years
ALL
Yes
Sponsors
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Vanessa Olbrecht
OTHER
Responsible Party
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Vanessa Olbrecht
Associate Professor of Anesthesiology
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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STUDY00002413
Identifier Type: -
Identifier Source: org_study_id