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

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ClinicalTrials.gov Identifier: NCT03787147
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Soo Yeon Kim, 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).

Condition or disease Intervention/treatment Phase
Pain Device: Google Cardboard Device: Oculus Drug: Lidocaine Hydrochloride Drug: Bupivacaine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The sealed envelope is randomized and blinded so no one will know which group the participant falls and its revealed only after the participant opens the sealed envelope.
Primary Purpose: Supportive Care
Official Title: Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)
Estimated Study Start Date : March 30, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Spinal Injection
Adults receiving Spinal Injection(SI) without Virtual Reality(VR).
Drug: Lidocaine Hydrochloride
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.

Drug: Bupivacaine
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.

Active Comparator: Google Cardboard
Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch
Device: Google Cardboard
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.

Drug: Lidocaine Hydrochloride
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.

Drug: Bupivacaine
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.

Active Comparator: Oculus
Adults receiving SI while using VR with Oculus Rift.
Device: Oculus
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.

Drug: Lidocaine Hydrochloride
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.

Drug: Bupivacaine
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.




Primary Outcome Measures :
  1. Pain intensity as measured by the Visual Analog Scale [ Time Frame: 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 :
  1. Anxiety Level as measured by the Visual Facial Anxiety Scale [ Time Frame: 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).

  2. Heart rate as measured by the Empatica E4 wristband [ Time Frame: 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.

  3. Systolic Blood Pressure as measured by the Empatica E4 wristband [ Time Frame: 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.

  4. Diastolic Blood Pressure as measured by the Empatica E4 wristband [ Time Frame: 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.

  5. Sympathetic skin response as measured by the Empatica E4 wristband [ Time Frame: 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.

  6. Temperature as measured by the Empatica E4 wristband [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787147


Contacts
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Contact: Soo Yeon Kim, MD 929-263-3869 sookim@montefiore.org

Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Soo Yeon Kim, MD Albert Einstein College of Medicine

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Responsible Party: Soo Yeon Kim, Assistant Professor, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03787147     History of Changes
Other Study ID Numbers: 2018-9613
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Soo Yeon Kim, Albert Einstein College of Medicine:
Virtual Reality
Spinal Injection
Adult
Analgesia
Google cardboard
Oculus

Additional relevant MeSH terms:
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Bupivacaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action