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OpenTrials
Completed

NCT Number: NCT05615675

Virtual Reality (VR) for Prone Pain Procedures

The purpose of this study is to evaluate the effectiveness of virtual reality (VR) distraction in patients undergoing interventional pain procedures in the prone position. VR has been shown to improve patient experience during interventional pain procedures, however, many of these procedures are done in the prone position making VR a challenge. This study will evaluate the effect of a VR headset and support in patients undergoing prone interventional pain procedures compared to control.

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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 18 years old or older, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure
  • English speaking and with the ability to understand oral and written instructions

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

Other

Patient uses a virtual reality headset and support during prone pain procedure

Other names: Oculus Quest Virtual Reality Headset

Primary outcomes

  1. Anxiety Score

    Time frame: Immediately before 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).

  2. Anxiety Score

    Time frame: 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. Anxiety Score

    Time frame: Immediately before procedure, during procedure, and immediately after procedure

    Anxiety score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)

  2. 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)

  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)

  5. Sedation Requirements

    Time frame: During course of procedure

    Amount of benzodiazepines and opioid medications given

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Immersive Audiovisual Distraction With Virtual Reality (VR) in Prone Procedures in the Interventional Pain Clinic

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2022
Registry last updated
Mar 25, 2025

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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