Patient Receptiveness to Using Virtual Reality

Patient Receptiveness to Using Virtual Reality as a Distractor From Pain

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	Change in subjective report of pain measured on a visual analog scale	Change between baseline and 5 minutes after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Heart Rate	Change in heart rate measured in beats per minute	Change between baseline and 5 minutes after intervention
Change in Anxiety	Change in subjective report of anxiety measured on a visual analog scale	Change between baseline and 5 minutes after intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): October 12, 2018
• Study Completion (Actual): October 12, 2018

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2017P002788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be collected without individual patient identifiers. Patient identifiers will be logged and separately in a locked confidential file.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No