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Patient Receptiveness to Using Virtual Reality

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.
 
ClinicalTrials.gov Identifier: NCT03528668
Recruitment Status : Unknown
Verified May 2018 by Paul Arnstein, Massachusetts General Hospital.
Recruitment status was:  Recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Paul Arnstein, Massachusetts General Hospital

Brief Summary:
This study will evaluate the acceptability, use, and general effect that exposure to virtual reality has on hospitalized patients reporting at least one discomfort including recent or current moderate-severe pain.

Condition or disease Intervention/treatment
Pain Anxiety Device: Virtual Reality Exposure

Detailed Description:
Patients with moderate-severe pain will be approached with approval of nursing staff and front line nurse manager who determine their appropriateness for a trial of virtual reality (VR) exposure for up to 30 minutes. The trial and use of VR will be explained after meeting the inclusion criteria and they will be asked about their level of interest in trying the VR headset. If interested, the subject will indicate their verbal consent to proceed with the VR trial. They will be asked about any baseline discomforts of pain, anxiety/stress or other discomfort; which will be rated on a 0-10 numeric (visual analog) scale. A baseline heart rate will be recorded in beats per minute. The headset will be applied and adjusted for comfort, then the app will be started along with a timer to track the duration of their use up to a maximum of 30 minutes. When the Headset is removed, the duration of use will be noted. The change in post-exposure heart rate (in beats per minute) and discomforts of pain, anxiety/stress or other discomforts (subtracting baseline from 5 minute post-exposure data) will be recorded. Subjects will be asked about the ease of use, whether or not they would use VR again, and for any other comments they would like to express. The headset will be disinfected between patient use.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Patient Receptiveness to Using Virtual Reality as a Distractor From Pain
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : October 12, 2018
Estimated Study Completion Date : October 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety


Intervention Details:
  • Device: Virtual Reality Exposure
    Exposure to Virtual Reality program for up to 30 minutes


Primary Outcome Measures :
  1. Change in Pain [ Time Frame: Change between baseline and 5 minutes after intervention ]
    Change in subjective report of pain measured on a visual analog scale


Secondary Outcome Measures :
  1. Change in Heart Rate [ Time Frame: Change between baseline and 5 minutes after intervention ]
    Change in heart rate measured in beats per minute

  2. Change in Anxiety [ Time Frame: Change between baseline and 5 minutes after intervention ]
    Change in subjective report of anxiety measured on a visual analog scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients on adult general care medical/surgical units, regardless of genders will be identified via an existing pain assessment dashboard that allows the investigator to identify patients with 3 or episodes of moderate-severe pain in the prior 24-hour period. The investigator will scan the report for potential subjects in accordance with participating units, inclusion and exclusion criteria. The front-line nurse manager and registered Nurse caring for to patient will be contacted for appropriateness to consider including and the timing when the patient can be approached without interrupting planned tests, treatments or workflow.
Criteria

Inclusion Criteria:

  • English-speaking
  • Inpatients on a general care unit
  • Current or recorded moderate to severe pain in past 24 hours

Exclusion Criteria:

  • Receiving palliative/end of life care;
  • Admitted for treatment of psychiatric or mental health disorder
  • History of seizure or stroke
  • Legally blind or deaf
  • Moderate or severe cognitive impairment
  • Head wounds or bandages
  • On isolation precautions.

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 ClinicalTrials.gov identifier (NCT number): NCT03528668


Contacts
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Contact: Paul M Arnstein, PhD (617)724-8517 pmarnstein@mgh.harvard.edu
Contact: Deena G Segal, PhD (857)282-1910 dsegal@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Paul M Arnstein, PhD    617-724-8517    pmarnstein@mgh.harvard.edu   
Contact: Deena G Segal, PhD    (857)282-1910    dsegal@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Paul M Arnstein, PhD Massachusetts General Hospital
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Responsible Party: Paul Arnstein, Clinical Nurse Specialist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03528668    
Other Study ID Numbers: 2017P002788
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be collected without individual patient identifiers. Patient identifiers will be logged and separately in a locked confidential file.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No