Virtual Reality (VR) for Prone Pain Procedures

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615675
• Other study ID #: 1919687-1
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2024
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: University of California, Davis
• Contact: Michael Jung, MD MBA
• Phone: 916-734-7246
• Email: mijjung[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Pain
• Virtual Reality

Intervention

Other:
• Virtual Reality Headset
Patient uses a virtual reality headset and support during prone pain procedure

Locations

Country	Name	City	State
United States	UC Davis Interventional Pain Clinic	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Anxiety Score	Anxiety score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)	Immediately before procedure, during procedure, and immediately after procedure
Secondary	Pain Score	Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)	Immediately before procedure, during procedure, and immediately after procedure
Secondary	Global Impression of Change	Global Impression of Change on a 7-point scale (Lower scores indicating decline in clinical status, and higher scores indicating improvement in clinical status)	Immediately after procedure
Secondary	Patient Experience Satisfaction	Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)	Immediately after procedure
Secondary	Sedation Requirements	Amount of benzodiazepines and opioid medications given	During course of procedure