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

Trial Summary

What is the purpose of this trial?

The study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decrease sedation requirements, enhance patient satisfaction, and reduce recovery time.

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 data supports the effectiveness of the treatment Virtual Reality (VR) for reducing sedation?

Research shows that virtual reality (VR) therapy can help reduce stress and anxiety, which might lower the need for sedation. VR has been used successfully in treating anxiety disorders and providing relaxation, suggesting it could be effective in reducing sedation needs. ^{1 2 3 4 5}

How does virtual reality treatment for reducing sedation differ from other treatments?

Virtual reality (VR) treatment is unique because it uses immersive, computer-generated environments to engage patients, which can help reduce the need for sedation by providing a calming and distracting experience. Unlike traditional sedation methods that rely on medication, VR offers a non-drug alternative that can be more accessible and user-friendly, especially for those who may not tolerate medications well. ^{2 4 6 7 8}

Research Team

Maysaa El Zoghbi, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The VEPSY UPDATED Project: clinical rationale and technical approach. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality Relaxation for Patients With a Psychiatric Disorder: Crossover Randomized Controlled Trial. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The future of cybertherapy: improved options with advanced technologies. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for Vietnam veterans with posttraumatic stress disorder. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Virtual Reality-Based Relaxation Techniques on Psychological, Physiological, and Biochemical Stress Indicators. [2021]