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

Pain Clinical Trial

— VR adult  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03787147
• Other study ID #: 2018-9613
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 30, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2021
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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