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).
Brief Title
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Pain
Eligibility 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
* 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
Inclusion Criteria
Inclusion Criteria:
* Adult requiring Spinal Injections
* Adult \> 18years
* Adults with intact vision who can attend VR intervention
* Adult requiring Spinal Injections
* Adult \> 18years
* Adults with intact vision who can attend VR intervention
Gender
All
Gender Based
false
Keywords
Virtual Reality
Spinal Injection
Adult
Analgesia
Google cardboard
Oculus
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03787147
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2018-9613
Overall Status
Withdrawn
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)
Primary Outcomes
Outcome Description
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).
Outcome Measure
Pain intensity as measured by the Visual Analog Scale
Outcome Time Frame
Immediately after receiving spinal injection
Secondary Outcomes
Outcome Description
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).
Outcome Time Frame
Immediately after receiving spinal injection
Outcome Measure
Anxiety Level as measured by the Visual Facial Anxiety Scale
Outcome Description
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.
Outcome Time Frame
Baseline, during and Immediately after the procedure
Outcome Measure
Heart rate as measured by the Empatica E4 wristband
Outcome Description
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.
Outcome Time Frame
Baseline, during and Immediately after the procedure
Outcome Measure
Systolic Blood Pressure as measured by the Empatica E4 wristband
Outcome Description
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.
Outcome Time Frame
Baseline, during and Immediately after the procedure
Outcome Measure
Diastolic Blood Pressure as measured by the Empatica E4 wristband
Outcome Description
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.
Outcome Time Frame
Baseline, during and Immediately after the procedure
Outcome Measure
Sympathetic skin response as measured by the Empatica E4 wristband
Outcome Description
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.
Outcome Time Frame
Baseline, during and Immediately after the procedure
Outcome Measure
Temperature as measured by the Empatica E4 wristband
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sayed Wahezi
Investigator Email
swahezi@montefiore.org
Investigator Phone