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Pain Procedures and Anxiolysis Via Distraction With Virtual Reality (PAIN-VR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04437173
Recruitment Status : Active, not recruiting
First Posted : June 18, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
The purpose of this study is to evaluate the efficacy of VR distraction on reducing anxiety patients undergoing interventional pain procedures compared to placebo/active placebo or a non VR option.

Condition or disease Intervention/treatment Phase
Virtual Reality Anxiety Pain Device: Virtual Reality Headset Distraction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Virtual Reality Arm
Patients undergo interventional pain procedure with virtual reality distraction
Device: Virtual Reality Headset Distraction
Patient wears a virtual reality headset during interventional pain procedure

No Intervention: No Intervention Arm
Patients undergo interventional pain procedure without virtual reality distraction



Primary Outcome Measures :
  1. Anxiety Score [ Time Frame: Immediately before procedure and immediately after procedure. ]
    State-Trait Anxiety Inventory (Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety; Total range 20 to 80 with higher scores indicating greater anxiety)


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: Immediately before procedure, during procedure, and immediately after procedure ]
    Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)

  2. Sedation Requirements [ Time Frame: During course of procedure ]
    Amount of benzodiazepines and opioid medications given

  3. Global Impression of Change [ Time Frame: Immediately after procedure ]
    Global Impression of Change on a 7-point scale (Lower scores indicating decline in clinical status, and higher scores indicating improvement in clinical status)

  4. Patient Experience Satisfaction [ Time Frame: Immediately after procedure ]
    Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged over 18 years old, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure
  • English speaking
  • Having the ability to understand oral and written instructions
  • Willing to fill out psychometric surveys.

Exclusion Criteria:

  • Pregnant women
  • Prisoners
  • Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437173


Locations
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United States, California
UC Davis Interventional Pain Clinic
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Naileshni Singh, MD University of California, Davis
Principal Investigator: John Sun, MD University of California, Davis
Principal Investigator: Michael Jung, MD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04437173    
Other Study ID Numbers: 1480456
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders