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OpenTrials
Completed

NCT Number: NCT03528668

Patient Receptiveness to Using Virtual Reality

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Exposure

Device

Exposure to Virtual Reality program for up to 30 minutes

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Patient Receptiveness to Using Virtual Reality as a Distractor From Pain

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 18, 2018
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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