Patient Receptiveness to Using Virtual Reality

Pain Clinical Trial

Official title:

Patient Receptiveness to Using Virtual Reality as a Distractor From Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528668
• Other study ID #: 2017P002788
• Status: Completed
• Start date: April 16, 2018
• Est. completion date: October 12, 2018

Study information

• Verified date: February 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: October 12, 2018
• Est. primary completion date: October 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain	Change in subjective report of pain measured on a visual analog scale	Change between baseline and 5 minutes after intervention
Secondary	Change in Heart Rate	Change in heart rate measured in beats per minute	Change between baseline and 5 minutes after intervention
Secondary	Change in Anxiety	Change in subjective report of anxiety measured on a visual analog scale	Change between baseline and 5 minutes after intervention