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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06236386
Other study ID # 2023-05-102
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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