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Trial record 1 of 1 for:    NCT02456987
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Virtual Reality in Inpatients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02456987
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : July 25, 2019
Information provided by (Responsible Party):
Brennan Spiegel, Cedars-Sinai Medical Center

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. Adapting existing VR environments for inpatients with a variety of impairments, utilizing cost-effective VR hardware (Phase 1).
  2. Assess the usability and acceptability of the VR equipment and software by hospital inpatients by conducting qualitative interviews (Phase 2).
  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).

Concerning Aims 2 and 3, we hypothesize the following:

  1. Inpatients will find the VR intervention helpful and enjoyable, and will believe that its benefits outweigh any difficulties encountered using the hardware or software.
  2. 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Samsung Gear Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Feasibility, Usability, Acceptability, and Clinical Utility of a Virtual Reality Intervention in the Inpatient Setting
Actual Study Start Date : June 30, 2015
Actual Primary Completion Date : November 21, 2016
Actual Study Completion Date : November 21, 2016

Arm Intervention/treatment
Experimental: Intervention
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
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.

No Intervention: Control
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.

Primary Outcome Measures :
  1. Qualitative Survey Instrument [ Time Frame: up to 10 min (Immediately following intervention) ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02456987

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
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Principal Investigator: Brennan Spiegel, MD, MSHS Cedars-Sinai Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Brennan Spiegel, Director, Health Services Research, Cedars-Sinai Medical Center Identifier: NCT02456987    
Other Study ID Numbers: Pro00039751
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations
Signs and Symptoms