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

Study Overview
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Brief Summary
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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).

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

Conditions
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Pain

Intervention / Treatment
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* Device: Google Cardboard
* Device: Oculus
* Drug: Lidocaine Hydrochloride
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Spinal Injection<br>Adults receiving Spinal Injection(SI) without Virtual Reality(VR). | Drug: Lidocaine Hydrochloride<br>* 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.<br>Drug: Bupivacaine<br>* 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.<br>|
| Active Comparator: Google Cardboard<br>Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch | Device: Google Cardboard<br>* 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.<br>Drug: Lidocaine Hydrochloride<br>* 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.<br>Drug: Bupivacaine<br>* 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.<br>|
| Active Comparator: Oculus<br>Adults receiving SI while using VR with Oculus Rift. | Device: Oculus<br>* 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.<br>Drug: Lidocaine Hydrochloride<br>* 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.<br>Drug: Bupivacaine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Immediately after receiving spinal injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | Baseline, during and Immediately after the procedure | 
| Sympathetic skin response 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 Sympathetic skin response before, during and after the procedure. | Baseline, during and Immediately after the procedure | 
| Temperature 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 Temperature before, during and after the procedure. | Baseline, during and Immediately after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Spinal Injection, Adult, Analgesia, Google cardboard, Oculus