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临床试验/NCT06236386
NCT06236386尚未招募不适用

Translating Virtual Reality Research Evidence Into Clinical Practice During Colonoscopy Procedures

University of Puerto Rico0 个研究点目标入组 120 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Preferred Video Type

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

VR Experience

Other

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

干预措施: VR Experience (Other)

结局指标

主要结局

Preferred Video Type

时间窗: 10 months

VR video type: video content (ocean, nature, space)

Medication Administration

时间窗: 10 months

Medications administered: opioids, benzodiazepines, other medication

Procedure Length

时间窗: 10 months

Length of the procedure: minutes

Recovery Time

时间窗: 10 months

Recovery time: minutes

VR Experience satisfaction

时间窗: 10 months

VR Experience satisfaction questions: 5-point Likert scale (1-Strongly disagree - 5 Strongly agree)

Clinician Feedback

时间窗: 10 months

Clinician Open-ended question about what would be changed from the process

Level of Pain

时间窗: 10 months

Numeric Rating Scale: 0 (No Pain) to 10 (worst possible pain)

Ramsay Score

时间窗: 10 months

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)

次要结局

  • Length of recovery(10 months)
  • Adverse Events(10 months)
  • Medication Use(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherily Pereira-Morales

Principal Investigator

University of Puerto Rico

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Virtual Reality During Colonoscopy Procedures | 临床试验