NCT03787147 - Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI) | Crick

Overview

A three-group parallel randomized controlled trial to evaluate the efficacy of virtual reality analgesia (VRA) to decrease patient procedural pain and anxiety in the Adult patients undergoing Spinal Injections (SI).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Conditions

Pain

Interventions

Google CardboardDEVICE

Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI). VRA is a the oculus or the google cardboard that helps decrease anxiety. The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.

OculusDEVICE

Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI). VRA is a the oculus or the google cardboard that helps decrease anxiety. The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.

Lidocaine HydrochlorideDRUG

All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition. Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adult requiring Spinal Injections * Adult \> 18years * Adults with intact vision who can attend VR intervention Exclusion Criteria: * Anyone \< 18 years * Adults who are not attentive to VR secondary to poor concentration, poor cognition to external stimuli * Adults who request moderate IV sedation * Adults with photic-induced seizures

Outcomes

Primary Outcomes

Pain intensity as measured by the Visual Analog Scale

Participants are asked to rate their intensity of pain, by completing a Visual Analog Scale (VAS). The VAS consists of lines and emojis used to indicate pain level; the lines range from 0 (= no pain) to 10 (= unbearable pain) and the emojis range from 0 (= no pain) to 5 (= unbearable pain).

Time frame: Immediately after receiving spinal injection

Secondary Outcomes

Anxiety Level as measured by the Visual Facial Anxiety Scale

Participants are asked to rate their anxiety level by completing the Visual Facial Anxiety Scale(VFAS). The VFAS consists of emojis ranging from 0 (= no anxiety) to 5 (highest anxiety).

Time frame: Immediately after receiving spinal injection

Heart rate as measured by the Empatica E4 wristband

The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure heart rate before, during and after the procedure.

Time frame: Baseline, during and Immediately after the procedure

Systolic Blood Pressure as measured by the Empatica E4 wristband

The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.

Time frame: Baseline, during and Immediately after the procedure

Diastolic Blood Pressure as measured by the Empatica E4 wristband

The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.