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Patient Receptiveness to Using Virtual Reality

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03528668
Collaborator
(none)
89
Enrollment
1
Location
5.9
Actual Duration (Months)
15.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

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

Outcome Measures

Primary Outcome Measures

  1. Change in Pain [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 [Change between baseline and 5 minutes after intervention]

    Change in heart rate measured in beats per minute

  2. Change in Anxiety [Change between baseline and 5 minutes after intervention]

    Change in subjective report of anxiety measured on a visual analog scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Paul M Arnstein, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paul Arnstein, Clinical Nurse Specialist, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT03528668
Other Study ID Numbers:
  • 2017P002788
First Posted:
May 18, 2018
Last Update Posted:
Feb 24, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 24, 2021