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Never started the study cause of the lack of funding
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Injection | Other | Adults receiving Spinal Injection(SI) without Virtual Reality(VR). |
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| Google Cardboard | Active Comparator | Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch |
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| Oculus | Active Comparator | Adults receiving SI while using VR with Oculus Rift. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Google Cardboard | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sayed Wahezi, MD | Albert Einstein College of Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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.
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| Oculus | Device | 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. |
|
| Lidocaine Hydrochloride | Drug | 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. |
|
| Bupivacaine | Drug | 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. |
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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 |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |