Virtual Reality During Colonoscopy Procedures (VR)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: VR Experience

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sherily Pereira-Morales, PhD, FAAN; Phone Number: 2717 7877582525; Email: sherily.pereira@upr.edu
• Study Contact Backup: Name: Susan Birkhoff, PhD,RN; Email: Susan.Birkhoff@ChristianaCare.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: VR Experience; A VR headset will be loaned to patients to be immersed in a VR environment while undergoing their colonoscopy.	Other: VR Experience; VR headset and video experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Pain	Numeric Rating Scale: 0 (No Pain) to 10 (worst possible pain)	10 months
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
Medication Administration	Medications administered: opioids, benzodiazepines, other medication	10 months
Procedure Length	Length of the procedure: minutes	10 months
Recovery Time	Recovery time: minutes	10 months
Preferred Video Type	VR video type: video content (ocean, nature, space)	10 months
VR Experience satisfaction	VR Experience satisfaction questions: 5-point Likert scale (1-Strongly disagree - 5 Strongly agree)	10 months
Clinician Feedback	Clinician Open-ended question about what would be changed from the process	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of recovery	Length of time in Recovery (minutes)	10 months
Adverse Events	Frequency of adverse events (name and number)	10 months
Medication Use	Medication administration comparison between two groups	10 months

Collaborators and Investigators

• Sponsor: University of Puerto Rico
• Investigators: Principal Investigator: Sherily Pereira, PhD, FAAN, University of Puerto Rico, Medical Sciences Campus, School of Nursing

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2023-05-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No