Virtual Reality During Colonoscopy Procedures

Colorectal Cancer Clinical Trial

— VR  

Official title:

Translating Virtual Reality Research Evidence Into Clinical Practice During Colonoscopy Procedures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06236386
• Other study ID #: 2023-05-102
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: University of Puerto Rico
• Contact: Sherily Pereira-Morales, PhD, FAAN
• Phone: 7877582525
• Email: sherily.pereira[@]upr.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• VR Experience
VR headset and video experience.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Puerto Rico

Outcome

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