Pain Procedures and Anxiolysis Via Distraction With Virtual Reality

Pain Clinical Trial

— PAIN-VR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437173
• Other study ID #: 1480456
• Status: Completed
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: February 9, 2022

Study information

• Verified date: September 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 9, 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Virtual Reality

Intervention

Device:
• Virtual Reality Headset Distraction
Patient wears a virtual reality headset during interventional 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 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	Sedation Requirements	Amount of benzodiazepines and opioid medications given	During course of 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