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OpenTrials
Completed

NCT Number: NCT04437173

Pain Procedures and Anxiolysis Via Distraction With Virtual Reality

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.

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Key information

Conditions

Virtual Reality Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Interventional Pain Clinic

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Headset Distraction

Device

Patient wears a virtual reality headset during interventional pain procedure

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic

Acronym: PAIN-VR

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2020
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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