Virtual Reality for Reducing Sedation

Overseen By Jessica Rauch

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Blindness, CAD, Seizures, Vertigo, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Virtual Reality (VR) goggles can reduce the amount of sedation needed during certain endoscopic procedures, such as colonoscopies. The researchers aim to determine if VR can increase patient comfort, shorten recovery time, and improve the overall experience. Participants will wear VR goggles with noise-canceling headphones and watch entertainment videos during the procedure. This trial is suitable for adults aged 21 to 65 undergoing these procedures at NYU Langone Brooklyn Hospital, provided they do not have conditions like a history of seizures or certain visual impairments. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance patient comfort and recovery in medical procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that using Virtual Reality goggles is safe during endoscopic procedures?

Research shows that Virtual Reality (VR) can be safely used during medical procedures. Studies have found that VR helps reduce anxiety and pain without causing serious side effects. For instance, one study discovered that VR was as effective as traditional sedation for managing pain and anxiety, but with fewer side effects like drowsiness. Another study showed that VR could reduce the need for sedatives during procedures, reassuring those concerned about medication risks. Overall, VR appears to be a safe and effective way to make medical procedures more comfortable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) during endoscopic procedures because it offers a unique, non-drug alternative to traditional sedation methods, like using medications such as midazolam or propofol. Unlike these drugs, VR provides an immersive experience that can distract and calm patients, potentially reducing the need for sedatives altogether. This innovative approach not only aims to enhance patient comfort but could also minimize the side effects and risks associated with sedation.

What evidence suggests that Virtual Reality is effective for reducing sedation during endoscopic procedures?

Research has shown that virtual reality (VR) can reduce pain and anxiety during medical procedures. In this trial, one group of participants will undergo an endoscopic procedure with a VR headset, potentially lowering the need for sedative drugs. This approach may reduce the amount of medication required for comfort. VR can also enhance the experience, improving overall patient satisfaction. Although VR isn't suitable for everyone, it offers a promising way to make medical procedures less stressful. Another group in this trial will undergo the endoscopic procedure without VR, serving as a control group for comparison. ^{1 3 4 6 7}

Who Is on the Research Team?

Maysaa El Zoghbi, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults aged 21 to 65 who are having a screening colonoscopy or diagnostic upper endoscopy. Participants must be suitable for minimal sedation. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I am between 21 and 65 years old.

Undergoing screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital

Exclusion Criteria

I am currently experiencing active bleeding in my digestive tract.

I have a history of coronary artery disease.

ASAII or III

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo endoscopic procedures with or without VR goggles and minimal sedation

1 day

1 visit (in-person)

Recovery

Participants are monitored in the PACU for safety and satisfaction, including assessment of complications and satisfaction scores

Approximately 30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any delayed complications or feedback post-procedure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality (VR)

Trial Overview The study tests if using VR goggles with noise-canceling headphones during endoscopic procedures can reduce the need for sedation, improve patient satisfaction, and speed up recovery.

How Is the Trial Designed?

Group I: Endoscopic Procedure with VR Headset Experimental Treatment 1 Intervention

VR google with noise cancellation headphones will be placed on patients' heads after a time-out. Patients can select from a range of entertainment videos prior and during the procedure. The anesthesiologist will administer minimal sedation. The patient can request additional sedation if needed. VR immersion continues until the procedure concludes and patients are moved to the recovery area. Goggles are removed in the recovery area

Group II: Endoscopic Procedure only Active Control 1 Intervention

The control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

The mobile game-based VR rehabilitation program (MoU-Rehab) significantly improved upper extremity function in stroke patients compared to conventional therapy, as measured by the Fugl-Meyer Assessment and other metrics.

The program was well-tolerated with no adverse effects reported, and patients expressed high satisfaction, indicating its feasibility as a rehabilitation tool for upper limb recovery after ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. Choi, YH., Ku, J., Lim, H., et al.[2019]

A study involving 50 psychiatric patients showed that the VR relaxation tool (VRelax) significantly reduced negative affective states, such as anxiety and sadness, more effectively than standard relaxation exercises.

Both VRelax and standard relaxation improved overall mood, but VRelax provided a greater immediate benefit in specific emotional states, suggesting it could be a valuable self-management tool for enhancing psychiatric treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Relaxation for Patients With a Psychiatric Disorder: Crossover Randomized Controlled Trial. Veling, W., Lestestuiver, B., Jongma, M., et al.[2021]

In an open clinical trial involving 10 Vietnam combat veterans with PTSD, virtual reality exposure therapy (VRE) led to a statistically significant reduction in PTSD symptoms at a 6-month follow-up, with reductions ranging from 15% to 67% for all participants.

The therapy was effective across all symptom clusters of PTSD, indicating that VRE could be a promising alternative treatment for veterans, although self-reported symptoms showed mixed results at the 6-month mark.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for Vietnam veterans with posttraumatic stress disorder. Rothbaum, BO., Hodges, LF., Ready, D., et al.[2019]

Virtual Reality (VR) interventions have been shown to significantly reduce symptoms of various anxiety disorders in adults, making them a promising alternative to traditional exposure therapy.

These VR treatments are generally well-accepted by clients and have minimal side effects, although caution is advised for Combat-Related PTSD in Vietnam veterans, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. Andersen, NJ., Schwartzman, D., Martinez, C., et al.[2023]

Participants with psychosis reported significant improvements in managing agoraphobic avoidance after using gameChange VR therapy, particularly those with severe avoidance, highlighting its efficacy as a therapeutic tool.

The immersive VR scenarios allowed users to confront their anxieties in a safe environment, enabling them to learn new coping strategies and gradually apply these skills in real-world situations, suggesting a promising mechanism for anxiety reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy. Bond, J., Kenny, A., Pinfold, V., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11440142/

Efficacy of virtual reality therapy versus pharmacological ... The use of virtual reality (VR) therapy has grown considerably, as it is effective for reducing pain and anxiety in different clinical areas.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11973126/

Impact of Immersive Virtual Reality During Outpatient ... In summary, our study showed a growing evidence of VR effectiveness in reducing anxiety and pain during colonoscopy, giving it a great potential ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06349564

Implementing Virtual Reality (VR) to Reduce Sedation The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decrease sedation requirements, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0016510724032607

Virtual reality intervention to improve quality of care during ... VR can improve patients' satisfaction and diminish the need for sedative medications; accordingly, it has the potential to promote cooperation and compliance ...

5. researchgate.net researchgate.net/publication/392424338_The_Effectiveness_of_Digital_Virtual_Reality-Based_Therapy_in_Reducing_Anxiety_Among_Patients_Undergoing_Gastrointestinal_Endoscopy

(PDF) The Effectiveness of Digital Virtual Reality-Based ... These findings suggest that the digital VR-based therapy was not statistically effective in reducing pre-endoscopy anxiety. Future interventions ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2352556825000153

Review article Virtual reality for reduction of intraprocedural ... VR immersion effectively reduces the required dose of intraprocedural sedatives, but its impact on opioid consumption remains unclear.

7. thelancet.com thelancet.com/journals/lansea/article/PIIS2772-3682(24)00087-8/fulltext

Multicenter, randomized, controlled comparative ... VR provides comparable benefit to sedation for procedure-related pain, anxiety and satisfaction, but with fewer side effects, superior ...