Virtual Reality Pain Study

Not Applicable

• Conditions: Hospitalized Patients 18 Years of Age or Older With Pain
• Interventions: Device: EaseVRx Virtual Reality Headset

• Registration Number: NCT05293275
• Lead Sponsor: Baylor Research Institute

Brief Summary

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

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 Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-15
• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-23
• Last Update Submitted: 2022-03-23
• Study First Posted: 2022-03-24
• Last Update Posted: 2022-03-24
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Group	EaseVRx Virtual Reality Headset	patients will use the virtual reality device over two days

Primary Outcome Measures

Name	Time	Method
Pain assessed by Numerical Pain Rating Scale	3-4 days	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)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Baylor Institute for Rehabilitation; 🇺🇸 Dallas, Texas, United States

Baylor Scott and White Hospital-Temple; 🇺🇸 Temple, Texas, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States