Clinical trial NCT05293275: Virtual Reality Pain Study
Official title: Virtual Reality as Nonpharmacologic Pain Management Among Hospitalized Inpatients. A Randomized Control Trial of Virtual Reality vs Standard of Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hospitalized Patients 18 Years of Age or Older With Pain
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain assessed by Numerical Pain Rating Scale
timeFrame: 3-4 days
Secondary outcomes:
measure: Anxiety assessed with numerical scale
timeFrame: 3-4 days
measure: The PROMIS sleep disturbance questionnaire
timeFrame: 3-4 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Institute for Rehabilitation
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White Hospital-Temple
state: Texas
Study officials:
affiliation: Research Center Director Trauma Research Consortium
name: Mark Powers, PhD
role: PRINCIPAL_INVESTIGATOR
References: