Virtual Reality Distraction for Reduction

NeuroTherapia, Inc.

Status: Completed

Conditions: Postoperative Pain

Treatments: Device: Placebo comparator: VR googles and the non reality experience; Device: Active Comparator: VR googles and the real VR program to enter act with and experience

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04416555

19-769

R44DA049640 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.

Full description

Specifically, the investigators propose to test the primary hypothesis that the use of AppliedVR software in Pico G2 4K headsets decreases acute postoperative pain scores (with a 1 point difference considered clinically important) compared to sham treatment on a 0-10 scale 15 minutes after each use in the first 48 hours after surgery or hospital discharge, whichever comes first.

Enrollment: 113 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiology Physical Status 1-3;
• Scheduled for elective, primary total hip arthroplasty;
• Anticipated hospitalization of at least 1 night;
• Expected to require parenteral opioids for postoperative pain;
• Able to use IV PCA systems.

Exclusion criteria

• History of chronic pain or care by a pain management specialist;
• Use of more than 30 mg/day of oral oxycodone (or equivalent);
• Greater than 12 weeks of current and continued opioid use;
• History of seizures, epilepsy, motion sickness, stroke, dementia;
• Non-English speaking;
• Women who are pregnant or breastfeeding;
• History of substance use disorder.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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113 participants in 2 patient groups, including a placebo group

VR googles using exposure sham program

Placebo Comparator group

Description:

The study groups will receive VR googles and the sham program

Treatment:

Device: Placebo comparator: VR googles and the non reality experience

VR googles and the real VR program experience.

Active Comparator group

Description:

The study group will receive the VR googles and the real VR program experience.

Treatment:

Device: Active Comparator: VR googles and the real VR program to enter act with and experience