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Virtual Reality Therapy for Pain Management During Laryngeal Procedures
N/A
Waitlist Available
Led By Anais Rameau, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the procedure
Awards & highlights
Study Summary
This trial will compare how well VR distracts patients from pain and anxiety during laryngeal procedures versus the standard of care.
Who is the study for?
This trial is for adults over 18 who are scheduled for certain voice box procedures at the Voice Institute, including biopsies and treatments for polyps. It's not suitable for those with motion sickness, visual impairments, seizures, or those who've taken psychotropic or pain meds in the last day.Check my eligibility
What is being tested?
The study tests if using a Virtual Reality headset during laryngeal procedures can reduce pain and anxiety compared to standard care. Patients will be randomly assigned to either use VR headsets during their procedure or receive the usual treatment without VR.See study design
What are the potential side effects?
Since this trial involves a non-invasive intervention (VR headset), side effects may include discomfort from wearing the device such as dizziness or nausea especially in individuals prone to motion sickness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measures will be recorded immediately before and immediately after the procedure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measures will be recorded immediately before and immediately after the procedure.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety
Galvanic Skin Activity
Heart rate
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: In-office procedure with VR-assistanceExperimental Treatment1 Intervention
Group II: In-office procedure without VR-assistanceActive Control1 Intervention
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,488 Total Patients Enrolled
Anais Rameau, M.D.Principal InvestigatorWeill Medical College of Cornell University
Anais Rameau, MDPrincipal InvestigatorWeill Medical College of Cornell University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am unable to give consent by myself.I am under 18 years old.I experience motion sickness or have severe vision problems.I have had seizures or problems with my vision in the past.I am scheduled for specific throat or esophagus procedures.I haven't taken any medication for pain or mood in the last 24 hours.I have previously undergone IOAEP treatment.
Research Study Groups:
This trial has the following groups:- Group 1: In-office procedure without VR-assistance
- Group 2: In-office procedure with VR-assistance
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being sought for this scientific experiment?
"Affirmative. According to the information gathered from clinicaltrials.gov, this research program is currently seeking enrolment; it first was launched on February 14th 2022 and has been updated recently on March 30th 2022. There are 56 spots available at a single site for interested participants."
Answered by AI
What is the headcount of participants involved in this research project?
"Affirmative. Per clinicaltrials.gov, this study is currently recruiting participants. The trial was first put up on February 14th 2022 and was most recently revised March 30th 2022. 56 volunteers are being sought from a single medical centre."
Answered by AI
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