Virtual Reality Pain Study (VR Pain)

Baylor Scott and White Health (BSWH)

Status: Unknown

Conditions: Hospitalized Patients 18 Years of Age or Older With Pain

Treatments: Device: EaseVRx Virtual Reality Headset

Study type: Interventional

Funder types: Other

Identifiers

NCT05293275

IRB 021-367

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Virtual Reality Group

Active Comparator group

Description:

patients will use the virtual reality device over two days

Treatment:

Device: EaseVRx Virtual Reality Headset

Standard of care

No Intervention group

Description:

patients will receive standard of care only