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

Phase 2

Withdrawn

• Conditions: Pain
• Interventions: Device: Oculus; Device: Google Cardboard; Drug: Lidocaine Hydrochloride; Drug: Bupivacaine

• Registration Number: NCT03787147
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-26
• Study Start: 2020-11-30
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult requiring Spinal Injections
• Adult > 18years
• Adults with intact vision who can attend VR intervention

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oculus	Oculus	Adults receiving SI while using VR with Oculus Rift.
Google Cardboard	Google Cardboard	Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch
Oculus	Bupivacaine	Adults receiving SI while using VR with Oculus Rift.
Spinal Injection	Bupivacaine	Adults receiving Spinal Injection(SI) without Virtual Reality(VR).
Spinal Injection	Lidocaine Hydrochloride	Adults receiving Spinal Injection(SI) without Virtual Reality(VR).
Google Cardboard	Lidocaine Hydrochloride	Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch
Google Cardboard	Bupivacaine	Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch
Oculus	Lidocaine Hydrochloride	Adults receiving SI while using VR with Oculus Rift.

Primary Outcome Measures

Name	Time	Method
Pain intensity as measured by the Visual Analog Scale	Immediately after receiving spinal injection	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).

Secondary Outcome Measures

Name	Time	Method
Anxiety Level as measured by the Visual Facial Anxiety Scale	Immediately after receiving spinal injection	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).
Heart rate as measured by the Empatica E4 wristband	Baseline, during and Immediately after the procedure	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.
Systolic Blood Pressure as measured by the Empatica E4 wristband	Baseline, during and Immediately after the procedure	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.
Temperature as measured by the Empatica E4 wristband	Baseline, during and Immediately after the procedure	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 Temperature before, during and after the procedure.
Diastolic Blood Pressure as measured by the Empatica E4 wristband	Baseline, during and Immediately after the procedure	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.
Sympathetic skin response as measured by the Empatica E4 wristband	Baseline, during and Immediately after the procedure	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 Sympathetic skin response before, during and after the procedure.