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Virtual Reality Software for Delirium

N/A

Waitlist Available

Led By Hina Faisal, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to undergo the following abdominal surgeries (open or laparoscopic or robotic assisted): small bowel and large bowel surgery; cholecystectomy; Whipple procedure; pancreatectomy; splenectomy.

≥60 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 minutes after the start of software use

Awards & highlights

Study Summary

This trial will test if using virtual reality software called ReCognitionVR is possible, liked by patients, and safe for older people who have had surgery. The results will help plan a future study for

Who is the study for?

This trial is for older patients who have recently undergone surgery and are at risk of developing delirium, a state of confusion. Participants must be able to give consent and follow study procedures. Those with conditions that may interfere with the use of virtual reality or increase risks, such as severe visual impairment or motion sickness, cannot join.Check my eligibility

What is being tested?

The study is testing how practical and acceptable it is to use ReCognitionVR software for cognitive stimulation compared to traditional methods in post-surgery care. It's a preliminary step before a larger trial on preventing delirium in critically ill patients.See study design

What are the potential side effects?

While not explicitly stated, potential side effects might include discomfort from wearing VR equipment, temporary dizziness or nausea due to virtual reality exposure (known as 'cybersickness'), and eye strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a specific type of abdominal surgery.

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I am 60 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 minutes after the start of software use

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 minutes after the start of software use

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes after the start of software use for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of treatment-emergent adverse events (TEAE)

Secondary outcome measures

Change From Baseline in Pulse Oximetry Oxygen Saturation after 10 Minutes

Change from baseline in diastolic blood pressure after 10 minutes

Change from baseline in diastolic blood pressure after completion

+6 more

Other outcome measures

Number of Attempts to Complete the Game

Number of Software and Device Resets

Number of Software and Device Restarts

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Reality SoftwareExperimental Treatment1 Intervention

Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software

Group II: Traditional Orientation MethodsActive Control1 Intervention

Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods,

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

271 Previous Clinical Trials

80,345 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,017,033 Total Patients Enrolled

35 Trials studying Delirium

38,599 Patients Enrolled for Delirium

Hina Faisal, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to enroll in this ongoing medical study?

"As per the up-to-date information obtained from clinicaltrials.gov, this specific clinical trial is not currently accepting new participants. The trial was initially posted on December 9th, 2023 and most recently updated on January 22nd, 2024. However, it's worth noting that there are presently 381 alternative ongoing trials actively seeking candidates for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients

Hina Faisal 2023. "Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06232317.

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