PAIN-VR: Pain Procedures and Anxiolysis Via Distraction With Virtual Reality

• Sponsor: University of California, Davis (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04437173
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.8
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Virtual Reality; Anxiety; Pain	Device: Virtual Reality Headset Distraction	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic
• Actual Study Start Date: Aug 7, 2020
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual Reality Arm Patients undergo interventional pain procedure with virtual reality distraction	Device: Virtual Reality Headset Distraction; Patient wears a virtual reality headset during interventional pain procedure
No Intervention: No Intervention Arm Patients undergo interventional pain procedure without virtual reality distraction

Outcome Measures

Primary Outcome Measures

1. Anxiety Score [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 Outcome Measures

1. Pain Score [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 [During course of procedure]

   Amount of benzodiazepines and opioid medications given

3. Global Impression of Change [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 [Immediately after procedure]

   Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Interventional Pain Clinic	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

• Principal Investigator: Naileshni Singh, MD, University of California, Davis
• Principal Investigator: John Sun, MD, University of California, Davis
• Principal Investigator: Michael Jung, MD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT04437173
• Other Study ID Numbers: 1480456
• First Posted: Jun 18, 2020
• Last Update Posted: Jun 7, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Jun 7, 2022