Recruiting

Virtual Reality

Sponsor:

Baylor Research Institute

Code:

NCT05293275

Conditions

Hospitalized Patients 18 Years of Age or Older With Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

EaseVRx Virtual Reality Headset

Study Details

Brief summary:

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

Conditions

Hospitalized Patients 18 Years of Age or Older With Pain

Study ID

NCT05293275

Start date

Mar 15, 2022

Status verified date

Mar, 2022

Completion date

Oct, 2023

Anticipated

Primary completion date

Oct, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Virtual Reality Group

patients will use the virtual reality device over two days

no intervention: Standard of care

patients will receive standard of care only

Interventions

EaseVRx Virtual Reality Headset

Virtual reality device with 360 degree visualization of various scenery and interactive modules

Primary outcome measure

  • Pain assessed by Numerical Pain Rating Scale [ Time Frame: 3-4 days ]

Central Contacts and Locations

Central contacts

Mark Powers, PhD

5129936443mak.powers1@bswhealth.org

Locations

Baylor Institute for Rehabilitation

Recruiting

Dallas, Texas, United States, 75246

Contacts

Tracy Birdsong

281-948-9625tracy.birdsong2@bswhealth.org

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Tracy Birdsong, MD

281-948-9625tracy.birdsong2@bswhealth.org

More Information

Sponsor

Baylor Research Institute

Last update posted

Mar 24, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2022-03-24.