Virtual Reality During Colonoscopy Procedures

NCT ID: NCT06236386

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-06-30

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

VR Experience

A VR headset will be loaned to patients to be immersed in a VR environment while undergoing their colonoscopy.

Group Type: OTHER

VR Experience

Intervention Type: OTHER

VR headset and video experience.

Interventions

VR Experience

VR headset and video experience.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Puerto Rico

OTHER

Sponsor Role: lead

Responsible Party

Sherily Pereira-Morales

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherily Pereira, PhD, FAAN

Role: PRINCIPAL_INVESTIGATOR

University of Puerto Rico, Medical Sciences Campus, School of Nursing

Central Contacts

Sherily Pereira-Morales, PhD, FAAN

Role: CONTACT

sherily.pereira@upr.edu

7877582525 ext. 2717

Susan Birkhoff, PhD,RN

Role: CONTACT

Susan.Birkhoff@ChristianaCare.org

Other Identifiers

2023-05-102

Identifier Type: -

Identifier Source: org_study_id