Virtual Reality Use for Peri-Procedural Analgesia and Anxiolysis

Acute Pain Clinical Trial

Official title: Evaluating the Efficacy and Feasibility of Virtual Reality Use for Peri-Procedural Analgesia and Anxiolysis: A Pilot Study

Status Not yet recruiting

Clinical Trial Summary

Currently, most analgesic regimens for painful bedside procedures rely on pharmacologic sedation or high doses of opioids (e.g.: nurse-administered IV opioids, anxiolytics, and sedatives; patient-controlled analgesia; anesthesiologist-administered sedation; and occasionally general anesthesia). Pharmacologic interventions are frequently associated with suboptimal analgesia, opioid-induced side effects, requirement for increased monitoring due to over sedation, and progressive acute tolerance to opioids over time, particularly with multiple/repeat procedures.

Alternative, non-pharmacologic strategies may help reduce pain, side-effects and opioid tolerance associated with painful bedside procedures. These strategies have not been studied as extensively, but are becoming more important in view of the current national opioid crisis. In particular, with recent technologic advancements, virtual reality (VR) has emerged as a non-pharmacologic modality for analgesia and anxiolysis, which can have tremendous benefits in acute pain management.

VR provides an immersive, realistic, often interactive experience for the user. It is frequently described as "transporting" the user to an alternate environment, with the use of high-fidelity head-mounted displays (HMD), noise-cancelling headsets, and a complete audio-visual experience. The user's sense of "presence" in the VR environment is crucial in providing patient engagement, and correlates with non-pharmacologic pain control.

VR has been shown to provide non-pharmacologic analgesia in children and adults undergoing painful procedures such as bedside wound care, burn treatment, and physical therapy. The use of VR during painful bedside procedures is one specific setting which offers a good starting point to investigate this technology for acute pain management.

Our study wishes to determine if VR plus standard therapy provides superior analgesia for painful bedside procedures (e.g. burn treatment, wound care) compared with standard therapy alone. Our primary outcome is a reduction in pain scores by 30%, as measured by a numerical analog scale (NAS) during painful bedside procedures. The investigators will use a randomized, cross-over study design in which hospitalized patients receiving repeated painful bedside procedures, will be randomized to 2 groups. Group A will have an initial painful bedside procedure under standard treatment only, and a repeat procedure under standard treatment + VR. Group B will have an initial procedure under standard treatment +VR, and a subsequent one under standard treatment. Questionnaires including pain scores and secondary outcomes will be administered to each patient before and after the bedside procedure. A convenience sample of patients will be recruited over 1 year (anticipated N~30).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acute Pain

• NCT number: NCT04218396
• Study type: Interventional
• Source: University of Calgary
• Contact: Linda Hung, MD, FRCPC
• Phone: 403-943-5554
• Email: linda.hung@albertahealthservices.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2020
• Completion date: January 20, 2021