Virtual Reality During Colonoscopy Procedures

NCT06236386 | Unknown DMC

• 1 other identifier: 2023-05-102
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Length of recovery

  10 months

• Adverse Events

  10 months

• Medication Use

  10 months

Study Arms (1)

VR Experience

OTHER

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

Other: VR Experience

Interventions

VR Experience OTHER

VR headset and video experience.

VR Experience

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to receive a colonoscopy procedure
• years of age or older
• Ability to read and speak in Spanish.

You may not qualify if:

• History of seizures
• Balance disorder
• Current infectious disease
• Cognitive and visual impairments
• Sedation intolerance
• History of motion sickness.

Sponsors & Collaborators

• University of Puerto Rico: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sherily Pereira, PhD, FAAN

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherily Pereira-Morales, PhD, FAAN

CONTACT

7877582525; sherily.pereira@upr.edu

Susan Birkhoff, PhD,RN

CONTACT

Susan.Birkhoff@ChristianaCare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will use a convergent mixed methods (QUAN + QUAL) design to measure the reach, effectiveness, adoption, implementation, and maintenance of translating VR evidence into practice. Qualitative data will be collected after the colonoscopy procedure by using a customized satisfaction survey, measuring the experience and satisfaction of patients and clinicians. Six months after launching this study, clinicians will be surveyed about their continuation of using VR during colonoscopy procedures. Individual quantitative and qualitative results will be merged initially through a convergent data analysis integration strategy that will compare both strands side by side. This strategy contributes to the overall interpretation of the findings.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: February 1, 2024
• Study Start: February 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share