Pain
Conditions
Keywords
Virtual Reality, Spinal Injection, Adult, Analgesia, Google cardboard, Oculus
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).
Interventions
DEVICEGoogle 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.
DEVICEOculus
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.
DRUGLidocaine 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.
DRUGBupivacaine
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.
Sponsors
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
Outcome results
None listed