Virtual Reality in Inpatients

NCT02456987 | Completed

• 1 other identifier: Pro00039751
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted as a pilot to test the feasibility, usability, acceptability, and clinical utility of using a virtual reality (VR) immersion experience in the inpatient setting. In addition to determining whether the patients enjoy the experience and would like to participate in a future more tailored immersion in virtual reality, we will be attempting to determine whether there are any positive impacts on their visit, including a distraction from their pain or anxiety associated with their procedures or the reason they have been admitted to the hospital. Because the inpatient population at Cedars-Sinai Medical Center (CSMC) is dynamic and diagnostically diverse, we intend to develop a series of VR interventions that broadly address patient concerns. VR has only been tested in select patient populations, so we are equally interested in the feasibility of deploying VR across the inpatient hospital environment as we are in demonstrating some effectiveness in reducing pain and anxiety, and improving satisfaction. The present study has the following aims:

1. 1.Adapting existing VR environments for inpatients with a variety of impairments, utilizing cost-effective VR hardware (Phase 1).
2. 2.Assess the usability and acceptability of the VR equipment and software by hospital inpatients by conducting qualitative interviews (Phase 2).
3. 3.Assess the clinical utility of the VR intervention by measuring patient reported outcomes using a modified care satisfaction survey, administered to inpatients receiving VR and a matched control sample (Phase 3).
4. 4.Inpatients will find the VR intervention helpful and enjoyable, and will believe that its benefits outweigh any difficulties encountered using the hardware or software.
5. 5.Inpatients who are exposed to the VR intervention will report significantly improved pain management, greater satisfaction with their inpatient visit, and greater overall health compared to matched control inpatients that were not exposed to VR.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Qualitative Survey Instrument

  Patients involved in the intervention will be asked a series of qualitative questions asking about their overall experience of the virtual reality intervention as well as the different virtual experiences and how they might change them.

  up to 10 min (Immediately following intervention)

Study Arms (2)

Intervention

EXPERIMENTAL

Patients that qualify for the intervention will receive the Samsung Gear virtual reality experiences and will participate in a brief survey about their opinions and preferences once the experiences are completed.

Device: Samsung Gear

Control

NO INTERVENTION

Age and sex matched control participants will be asked to answer a series of satisfaction questions after the study recruitment period is over. These individuals will have been inpatients during the same time as the intervention participants.

Interventions

Samsung Gear DEVICE

Intervention arm will be exposed to a series of virtual reality experiences using the Samsung Gear hardware one time during their inpatient stay at Cedars-Sinai.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the goals of the study and provide informed consent
• Any Inpatient at CSMC ISP, admitted between June 2015 and 31 December 2016, who is not excluded due to criteria listed below.
• At least 18 years of age
• English speaking

You may not qualify if:

• Unable to consent to study due to cognitive difficulty
• Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software
• Vision requiring correction with eyeglasses (except nearsightedness, which can be accommodated by the Gear VR goggles)
• Sensitivity to flashing light or motion\*
• Recent stroke
• Transplant patient
• Patient on ventilator, BiPAP, or other breathing assistance equipment
• Recent injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software\*
• Non-English speaking

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (2)

• Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.

  PMID: 28356241 DERIVED

• Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.

  PMID: 27349654 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brennan Spiegel, MD, MSHS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Health Services Research

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: May 29, 2015
• Study Start: June 30, 2015
• Primary Completion: November 21, 2016
• Study Completion: November 21, 2016
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)