Virtual Reality Pain Study (VR Pain)

Virtual Reality as Nonpharmacologic Pain Management Among Hospitalized Inpatients. A Randomized Control Trial of Virtual Reality vs Standard of Care

Investigating pain in hospitalized patients in two groups: virtual reality usage group vs standard of care

Study Overview

• Status: Recruiting
• Conditions: Hospitalized Patients 18 Years of Age or Older With Pain
• Intervention / Treatment: Device: EaseVRx Virtual Reality Headset

Detailed Description

Patients will be randomized to either the virtual reality group or the standard of care group. The virtual reality group will use the device over two days. Both groups will answer questionnaires regarding their pain and anxiety. Medical records will be used to look at pain medication usage in both groups.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Powers, PhD; Phone Number: 5129936443; Email: mak.powers1@bswhealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor University Medical Center
      • Contact: Tracy Birdsong, MD; Phone Number: 281-948-9625; Email: tracy.birdsong2@bswhealth.org
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Institute for Rehabilitation
      • Contact: Tracy Birdsong; Phone Number: 281-948-9625; Email: tracy.birdsong2@bswhealth.org
    • Temple, Texas, United States, 76508
      • Not yet recruiting
      • Baylor Scott and White Hospital-Temple
      • Contact: Kimberly Trembly, NP; Phone Number: 254-724-2111; Email: kristina.trembly@bswhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • patients at least 18 years of age,

  • reported pain in last 24 hours ≥ 3 on the Numerical Rating Scales (NRS),
  • patients undergoing surgery,
  • expected hospital length of stay of at least 48 hours,
  • English fluency,
  • willing to comply with study procedures.
  • Hx opioid use

Exclusion Criteria:

• • gross cognitive impairment that would interfere with the ability to consent or complete study procedures

  • current or prior diagnosis of epilepsy, seizure disorder, dementia, or migraines,
  • hypersensitivity to flashing light or motion,
  • history of motion sickness or cyber sickness,
  • medical condition predisposing to or current nausea, vomiting or dizziness,
  • stereoscopic vision or severe hearing impairment,
  • injury to eyes, face or neck that impedes comfortable use of virtual reality,
  • cancer related pain,
  • PHQ-9 screen indicating suicidal ideation, patients will be referred to appropriate clinical intervention (see suicide protocol)
  • currently pregnant,
  • current or recent completion of participation in any interventional pain study (with in past 2 months)
  • substance abuse (alcohol or illegal drugs): Alcohol- NIAAA definition of heavy drinking as more than 4 drinks on any day or more than 14 drinks per week for men, more than 3 drinks on any day or more than 7 drinks per week for women. Any illegal drugs including marijuana

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Virtual Reality Group; patients will use the virtual reality device over two days	Device: EaseVRx Virtual Reality Headset; Virtual reality device with 360 degree visualization of various scenery and interactive modules
No Intervention: Standard of care; patients will receive standard of care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessed by Numerical Pain Rating Scale	level of pain will be assessed using the Numerical Pain Rating Scale. The scale is composed of 0 (no pain) to 10 (worst pain imaginable)	3-4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety assessed with numerical scale	level of anxiety assessed with numerical scale composed of 0 (no anxiety) to 10 (anxiety out of control)	3-4 days
The PROMIS sleep disturbance questionnaire	disruption of sleep assessed using the PROMIS sleep disturbance questionnaire	3-4 days

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Mark Powers, PhD, Research Center Director Trauma Research Consortium

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB 021-367

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No