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

NCT ID: NCT03787147

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2020-12-01

Brief Summary

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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).

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Spinal Injection

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

Group Type OTHER

Lidocaine Hydrochloride

Intervention Type 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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Google Cardboard

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Oculus

Adults receiving SI while using VR with Oculus Rift.

Group Type ACTIVE_COMPARATOR

Oculus

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sayed Wahezi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sayed Wahezi, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Other Identifiers

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2018-9613

Identifier Type: -

Identifier Source: org_study_id

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