Colorectal CancerVRNCT06236386
Virtual Reality During Colonoscopy Procedures
A study testing VR Experience in people with Colorectal Cancer, run by University of Puerto Rico.
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%). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- VR Experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled to receive a colonoscopy procedure
- 21 years of age or older
- Ability to read and speak in Spanish.
Who cannot join
- History of seizures
- Balance disorder
- Current infectious disease
- Cognitive and visual impairments
- Sedation intolerance
- History of motion sickness.
Trial locations and contacts
No sites are listed yet.
Susan Birkhoff, PhD,RN contact
About this study
Official title: 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.
Read the 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
- Being tested
- VR Experience
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR ExperienceOther
VR headset and video experience.
| Study group | Role | What they receive |
|---|---|---|
| VR Experience | Other | A VR headset will be loaned to patients to be immersed in a VR environment while undergoing their colonoscopy. Receives: Other: VR Experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Pain
Numeric Rating Scale: 0 (No Pain) to 10 (worst possible pain)
Measured: 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)
Measured: 10 months
Medication Administration
Medications administered: opioids, benzodiazepines, other medication
Measured: 10 months
Procedure Length
Length of the procedure: minutes
Measured: 10 months
Recovery Time
Recovery time: minutes
Measured: 10 months
Preferred Video Type
VR video type: video content (ocean, nature, space)
Measured: 10 months
VR Experience satisfaction
VR Experience satisfaction questions: 5-point Likert scale (1-Strongly disagree - 5 Strongly agree)
Measured: 10 months
Clinician Feedback
Clinician Open-ended question about what would be changed from the process
Measured: 10 months
Secondary outcomes (3)
Length of recovery
Length of time in Recovery (minutes)
Measured: 10 months
Adverse Events
Frequency of adverse events (name and number)
Measured: 10 months
Medication Use
Medication administration comparison between two groups
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherily Pereira-Morales, University of Puerto Rico
- Investigators
- Sherily Pereira, PhD, FAAN, Principal investigator, University of Puerto Rico, Medical Sciences Campus, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236386
- Sponsor's protocol ID
- 2023-05-102
- Acronym
- VR
- Status last verified
- Jan 2024
- First submitted
- 4 Oct 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Virtual Reality Research Evidence Into Clinical Practice During Colonoscopy Procedures
- ClinicalTrials.gov ID
- NCT06236386
- Acronym / sponsor ID
- VR / 2023-05-102
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR Experience | Other | Other: VR ExperienceA VR headset will be loaned to patients to be immersed in a VR environment while undergoing their colonoscopy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to receive a colonoscopy procedure
- 21 years of age or older
- Ability to read and speak in Spanish.
Key exclusion criteria (6 listed)
- History of seizures
- Balance disorder
- Current infectious disease
- Cognitive and visual impairments
- Sedation intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR ExperienceVR headset and video experience. | Other | VR Experience |
Primary outcome
Level of Pain
Time frame: 10 months
Numeric Rating Scale: 0 (No Pain) to 10 (worst possible pain)
Ramsay Score
Time frame: 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)
Medication Administration
Time frame: 10 months
Medications administered: opioids, benzodiazepines, other medication
Procedure Length
Time frame: 10 months
Length of the procedure: minutes
Recovery Time
Time frame: 10 months
Recovery time: minutes
Preferred Video Type
Time frame: 10 months
VR video type: video content (ocean, nature, space)
VR Experience satisfaction
Time frame: 10 months
VR Experience satisfaction questions: 5-point Likert scale (1-Strongly disagree - 5 Strongly agree)
Clinician Feedback
Time frame: 10 months
Clinician Open-ended question about what would be changed from the process
3 secondary outcomes
Length of recovery
Time frame: 10 months
Adverse Events
Time frame: 10 months
Medication Use
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Birkhoff, PhD,RN contact
Sherily Pereira, PhD, FAAN principal investigator
University of Puerto Rico, Medical Sciences Campus, School of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing VR Experience in people with Colorectal Cancer, run by University of Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherily Pereira-Morales, PhD, FAAN (7877582525 ext. 2717, sherily.pereira@upr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Pain (time frame: 10 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.