Colorectal Cancer Clinical Trial
— VROfficial title:
Translating Virtual Reality Research Evidence Into Clinical Practice During Colonoscopy Procedures
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%). Fear 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. Strong 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.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | June 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Scheduled to receive a colonoscopy procedure - 21 years of age or older - Ability to read and speak in Spanish. Exclusion Criteria: - History of seizures - Balance disorder - Current infectious disease - Cognitive and visual impairments - Sedation intolerance - History of motion sickness. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Puerto Rico |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of Pain | Numeric Rating Scale: 0 (No Pain) to 10 (worst possible pain) | 10 months | |
Primary | Ramsay Score | 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) | 10 months | |
Primary | Medication Administration | Medications administered: opioids, benzodiazepines, other medication | 10 months | |
Primary | Procedure Length | Length of the procedure: minutes | 10 months | |
Primary | Recovery Time | Recovery time: minutes | 10 months | |
Primary | Preferred Video Type | VR video type: video content (ocean, nature, space) | 10 months | |
Primary | VR Experience satisfaction | VR Experience satisfaction questions: 5-point Likert scale (1-Strongly disagree - 5 Strongly agree) | 10 months | |
Primary | Clinician Feedback | Clinician Open-ended question about what would be changed from the process | 10 months | |
Secondary | Length of recovery | Length of time in Recovery (minutes) | 10 months | |
Secondary | Adverse Events | Frequency of adverse events (name and number) | 10 months | |
Secondary | Medication Use | Medication administration comparison between two groups | 10 months |
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