Virtual Reality Analgesia In Trauma Rehab

NCT03894592 | Unknown

• 1 other identifier: 2018-9196
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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; Trauma Injury

Outcome Measures

Primary Outcomes (1)

• Change in pain perception

  will be measured using the Visual Analogue Scale (VAS) for all subjects pre-, during and post-intervention via self-report. The scale values range from 0 to 10. ) being no pain and 10 being the worst pain

  1 year

Secondary Outcomes (4)

• Increase or decrease in opioid/oral pain medication use

  1 year

• Heart Rate

  1 year

• Patient reported anxiety

  1 year

• Blood Pressure

  1 year

Study Arms (2)

Virtual Reality analgesia

ACTIVE COMPARATOR

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

Other: Virtual reality

Control

NO INTERVENTION

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 OTHER

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

Virtual Reality analgesia

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Pain; Anxiety Disorders; Accidental Injuries

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Wounds and Injuries

Study Officials

• Michelle Stern, MD

  New York City Health and Hospitals Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Stern, MD

CONTACT

9175779543; Michelle.Stern@nychhc.org

Ratnakar P Veeramachaneni, MD

CONTACT

7182077551; rveerama@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sequentially Numbered opaque sealed envelopes ( SNOSE) and an online randomization tool
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Randomized control study. The pre and post VAS scores will be rated by the patient. Randomization will be achieved using Sequentially Numbered opaque sealed envelopes ( SNOSE) and an online randomization tool. All the patients will choose one of three virtual reality experiences. 1. Passive VR Movie 2. Interactive relaxation/exploration 3. Active/Adventure experience

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: March 28, 2019
• Study Start: August 1, 2019
• Primary Completion: July 2, 2020
• Study Completion: October 1, 2020
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)