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

NCT03787147 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 2018-9613
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pain

Keywords

Virtual Reality; Spinal Injection; Adult; Analgesia; Google cardboard; Oculus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Anxiety Level as measured by the Visual Facial Anxiety Scale

  Immediately after receiving spinal injection

• Heart rate as measured by the Empatica E4 wristband

  Baseline, during and Immediately after the procedure

• Systolic Blood Pressure as measured by the Empatica E4 wristband

  Baseline, during and Immediately after the procedure

• Diastolic Blood Pressure as measured by the Empatica E4 wristband

  Baseline, during and Immediately after the procedure

• Sympathetic skin response as measured by the Empatica E4 wristband

  Baseline, during and Immediately after the procedure

Study Arms (3)

Spinal Injection

OTHER

Adults receiving Spinal Injection(SI) without Virtual Reality(VR).

Drug: Lidocaine Hydrochloride; Drug: Bupivacaine

Google Cardboard

ACTIVE COMPARATOR

Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch

Device: Google Cardboard; Drug: Lidocaine Hydrochloride; Drug: Bupivacaine

Oculus

ACTIVE COMPARATOR

Adults receiving SI while using VR with Oculus Rift.

Device: Oculus; Drug: Lidocaine Hydrochloride; Drug: Bupivacaine

Interventions

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.

Google Cardboard

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.

Oculus

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.

Google Cardboard; Oculus; Spinal Injection

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.

Google Cardboard; Oculus; Spinal Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult requiring Spinal Injections
• Adult \> 18years
• Adults with intact vision who can attend VR intervention

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sayed Wahezi, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 26, 2018
• Study Start: November 30, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share