Virtual Reality During Colonoscopy Procedures
- Conditions
- Colorectal Cancer
- Interventions
- Other: VR Experience
- Registration Number
- NCT06236386
- Lead Sponsor
- University of Puerto Rico
- Brief Summary
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.
- Detailed Description
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:
Aim 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.
Aim 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Scheduled to receive a colonoscopy procedure
- 21 years of age or older
- Ability to read and speak in Spanish.
- History of seizures
- Balance disorder
- Current infectious disease
- Cognitive and visual impairments
- Sedation intolerance
- History of motion sickness.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VR Experience VR Experience A VR headset will be loaned to patients to be immersed in a VR environment while undergoing their colonoscopy.
- Primary Outcome Measures
Name Time Method Preferred Video Type 10 months VR video type: video content (ocean, nature, space)
Medication Administration 10 months Medications administered: opioids, benzodiazepines, other medication
Procedure Length 10 months Length of the procedure: minutes
Recovery Time 10 months Recovery time: minutes
VR Experience satisfaction 10 months VR Experience satisfaction questions: 5-point Likert scale (1-Strongly disagree - 5 Strongly agree)
Clinician Feedback 10 months Clinician Open-ended question about what would be changed from the process
Level of Pain 10 months Numeric Rating Scale: 0 (No Pain) to 10 (worst possible pain)
Ramsay Score 10 months 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)
- Secondary Outcome Measures
Name Time Method Length of recovery 10 months Length of time in Recovery (minutes)
Adverse Events 10 months Frequency of adverse events (name and number)
Medication Use 10 months Medication administration comparison between two groups