Virtual Reality (VR) for Prone Pain Procedures

NCT05615675 | Completed

• 1 other identifier: 1919687
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Virtual Reality; Anxiety; Pain

Outcome Measures

Primary Outcomes (2)

• Anxiety Score

  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).

  Immediately before procedure

• Anxiety Score

  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).

  Immediately after procedure

Secondary Outcomes (5)

• Anxiety Score

  Immediately before procedure, during procedure, and immediately after procedure

• Pain Score

  Immediately before procedure, during procedure, and immediately after procedure

• Global Impression of Change

  Immediately after procedure

• Patient Experience Satisfaction

  Immediately after procedure

• Sedation Requirements

  During course of procedure

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Patients undergo prone pain procedure with virtual reality distraction

Other: Virtual Reality Headset

Control

NO INTERVENTION

Patients undergo prone pain procedure without virtual reality distraction

Interventions

Virtual Reality Headset OTHER

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

Also known as: Oculus Quest Virtual Reality Headset

Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Interventional Pain Clinic

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Jung, MD MBA

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: November 14, 2022
• Study Start: May 13, 2024
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)