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Virtual Reality Distraction for Reduction

NeuroTherapia, Inc. logo

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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