Pain Procedures and Anxiolysis Via Distraction With Virtual Reality

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04437173

Acronym

PAIN-VR

Enrollment

Registered

2020-06-18

Start date

2020-08-07

Completion date

2022-02-09

Last updated

2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain, Virtual Reality

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.

Interventions

DEVICEVirtual Reality Headset Distraction

Patient wears a virtual reality headset during interventional pain procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
Sedation Requirements	During course of procedure	Amount of benzodiazepines and opioid medications given
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)
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026