Recruiting

Virtual Reality

Sponsor:

New York City Health and Hospitals Corporation

Code:

NCT03894592

Conditions

Virtual Reality

Musculoskeletal Pain

Opioid Use

Anxiety

Virtual Reality Analgesia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Virtual reality

Study Details

Brief summary:

This will be a pilot study utilizing Virtual Reality Analgesia (VRA) as a first line nonpharmacologic analgesic intervention on the Acute Rehabilitation Unit. In order to assess the efficacy of the intervention with a set of outcome measures will be defined:

  • Pain will be measured using the VAS for all subjects pre-, during and post-intervention via self-report.
  • Number of opioids/oral pain medication consumed will be analyzed
  • Patient anxiety will be measured on the Short ( State-Trait Anxiety Index) STAI anxiety scale pre- and post-intervention.
  • Heart rate and blood pressure will also be measured pre and post intervention.

Conditions

Virtual Reality

Musculoskeletal Pain

Opioid Use

Anxiety

Virtual Reality Analgesia

Study ID

NCT03894592

Start date

Aug 1, 2019

Status verified date

Jul, 2019

Completion date

Oct, 2020

Anticipated

Primary completion date

Jul 2, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult with Traumatic injury on the Acute Rehab Unit
  • Adult ages 18-100
  • Adult with intact vision who can attend VR intervention
  • Adult receiving PO Medications
  • Adult with motor control of at least one arm

Exclusion Criteria:

  • Adult who has uncontrolled seizures more than 4 times per year
  • Adult who is not attentive to VR secondary to poor concentration/poor cognition to external stimuli.
  • Adult with no volitional control of the neck and or upper extremities.

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Virtual Reality analgesia

Trauma patients in rehab unit in the participating hospital will be included in this arm if they are randomized to receive the intervention which is a virtual reality headset providing immersive interactive content in the video format

no intervention: Control

Trauma patients in rehab unit in the participating hospital will be included in this arm if they are randomized to receive no intervention

Interventions

Virtual reality

Trauma patients enrolled in the study will be offered Virtual Reality experieince per the protocol

Primary outcome measure

  • Change in pain perception [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Michelle Stern, MD

9175779543Michelle.Stern@nychhc.org

Ratnakar P Veeramachaneni, MD

7182077551rveerama@montefiore.org

Locations

Jacobi Medical Center

Recruiting

Bronx, New York, United States, 10461

Contacts

Stern Michelle, MD

917-577-9543michelle.stern@nychhc.org

More Information

Sponsor

New York City Health and Hospitals Corporation

Last update posted

Jul 26, 2019

Last verified

Jul, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York City Health and Hospitals Corporation on 2019-07-26.