Virtual Reality Pain Study

NCT ID: NCT05293275

Last Updated: 2022-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2023-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hospitalized Patients 18 Years of Age or Older With Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality Group

patients will use the virtual reality device over two days

Group Type ACTIVE_COMPARATOR

EaseVRx Virtual Reality Headset

Intervention Type DEVICE

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

Standard of care

patients will receive standard of care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EaseVRx Virtual Reality Headset

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Mark B Powers

Research Center Director Trauma Research Consortium

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Powers, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Center Director Trauma Research Consortium

Locations

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Baylor Institute for Rehabilitation

Dallas, Texas, United States

Site Status RECRUITING

Baylor University Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Baylor Scott and White Hospital-Temple

Temple, Texas, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Mark Powers, PhD

Role: CONTACT

5129936443

Facility Contacts

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Tracy Birdsong

Role: primary

281-948-9625

Tracy Birdsong, MD

Role: primary

281-948-9625

Kimberly Trembly, NP

Role: primary

254-724-2111

Other Identifiers

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IRB 021-367

Identifier Type: -

Identifier Source: org_study_id

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