Clinical trial NCT04218396: Virtual Reality Use for Peri-Procedural Analgesia and Anxiolysis
Official title: Evaluating the Efficacy and Feasibility of Virtual Reality Use for Peri-Procedural Analgesia and Anxiolysis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pain
Keywords: Acute Pain
Virtual Reality
Anxiolysis
Analgesia
Non-pharmacologic
Painful bedside procedure
Wound care
Dressing change
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing recurrent painful bedside procedures during hospitalization (at least 2 similar procedures during the course of hospital stay eg: wound dressing change)
* Anticipated duration of bedside procedure less than or equal to 2 hours
* Patients 18 years or older and able to provide informed consent
* Patients experiencing pain and/or anxiety from their bedside procedure (these patients are expected to benefit most from the analgesic/anxiolytic effects of VR).
* Patients who not wish to observe the painful bedside procedure (VR unit will provide sensory distraction and immersive experience, with HMD/goggles/headset, that allows patient not to witness procedure).
* Patients with adequate vision and hearing (with hearing aids if necessary) - patients with sensory limitations may not be able to benefit from the full effects of the VR sensory stimulation.
* Patients who are medically stable (should be free of acute conditions that could be dangerous when using VR)

Exclusion Criteria:

* Active seizure disorder, recent stroke (within 3 months), elevated intracranial pressure (visual and/or auditory stimulation may cause concerns with worsening acute central nervous system conditions)
* High risk for or active substance withdrawal; active substance intoxication (VR stimulation may worsen symptoms associated with substance intoxication and withdrawal)
* Active delirium (may preclude safe and effective use of VR as intended for anxiolysis and analgesia)
* Poor vision and hearing (precludes VR stimuli from being effective if the patient has sensory impairments that prevent them from seeing/hearing the VR effects)
* Open head/neck wound or head/neck injuries precluding safe use or wearing of the VR unit (headset, HMD, headphones)
* Body parasites, active eye infection, or other infectious diseases requiring contact isolation, droplet isolation, or airborne isolation (this exclusion limits the possibility of transmitting infectious diseases between patients with the use of the VR unit)

Primary outcomes:
measure: Numerical Analog Scale Pain Score
timeFrame: During painful bedside procedure
Secondary outcomes:
measure: Anxiety score - State Trait Anxiety Index short form questionnaire
timeFrame: During painful bedside procedure
measure: Quality of life measures - Quality of Recovery 15 questionnaire
timeFrame: During painful bedside procedure
measure: Opioid use during painful bedside procedure
timeFrame: During painful bedside procedure
measure: Number of participants with side effects related to virtual reality use during painful beside procedure (Nausea, dizziness, and other patient-reported adverse events)
timeFrame: During painful bedside procedure
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Linda Hung, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.
citation: Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.
citation: Gupta A, Scott K, Dukewich M. Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It? Pain Med. 2018 Jan 1;19(1):151-159. doi: 10.1093/pm/pnx109.