PainPhase 2VR adultNCT03787147
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)
A Phase 2 study testing Google Cardboard, Oculus and Lidocaine Hydrochloride in people with Pain, run by Albert Einstein College of Medicine.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Google Cardboard, Oculus and Lidocaine Hydrochloride
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2020to 1 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult requiring Spinal Injections
- Adult > 18years
- Adults with intact vision who can attend VR intervention
Who cannot join
- 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
About this study
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
- Being tested
- Google Cardboard, Oculus, Lidocaine Hydrochloride, Bupivacaine
- Keywords
- Virtual Reality, Spinal Injection, Adult, Analgesia, Google cardboard, Oculus
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Google CardboardDevice
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.
OculusDevice
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 HydrochlorideDrug
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.
BupivacaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Injection | Other | Adults receiving Spinal Injection(SI) without Virtual Reality(VR). Receives: 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 Receives: Device: Google Cardboard; Drug: Lidocaine Hydrochloride; Drug: Bupivacaine |
| Oculus | Active comparator | Adults receiving SI while using VR with Oculus Rift. Receives: Device: Oculus; Drug: Lidocaine Hydrochloride; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately after receiving spinal injection
Secondary outcomes (6)
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).
Measured: Immediately after receiving spinal injection
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, during and Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start30 Nov 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Why it stopped: Never started the study cause of the lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Wahezi, Albert Einstein College of Medicine
- Investigators
- Sayed Wahezi, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787147
- Sponsor's protocol ID
- 2018-9613
- Acronym
- VR adult
- Status last verified
- Jan 2021
- First submitted
- 5 Dec 2018
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)
- ClinicalTrials.gov ID
- NCT03787147
- Acronym / sponsor ID
- VR adult / 2018-9613
- Conditions
- Pain
- Keywords
- Virtual Reality, Spinal Injection, Adult, Analgesia, Google cardboard, Oculus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never started the study cause of the lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spinal Injection | Other | Drug: Lidocaine Hydrochloride, Drug: BupivacaineAdults receiving Spinal Injection(SI) without Virtual Reality(VR). |
| Google Cardboard | Active comparator | Device: Google Cardboard, Drug: Lidocaine Hydrochloride, Drug: BupivacaineAdults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch |
| Oculus | Active comparator | Device: Oculus, Drug: Lidocaine Hydrochloride, Drug: BupivacaineAdults receiving SI while using VR with Oculus Rift. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult requiring Spinal Injections
- Adult > 18years
- Adults with intact vision who can attend VR intervention
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Google CardboardAssessing 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. | Device | Google Cardboard |
| OculusAssessing 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. | Device | Oculus |
| Lidocaine HydrochlorideAll 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. | Drug | Google Cardboard, Oculus, Spinal Injection |
| BupivacaineAll 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. | Drug | Google Cardboard, Oculus, Spinal Injection |
Primary outcome
Pain intensity as measured by the Visual Analog Scale
Time frame: 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).
6 secondary outcomes
Anxiety Level as measured by the Visual Facial Anxiety Scale
Time frame: Immediately after receiving spinal injection
Heart rate as measured by the Empatica E4 wristband
Time frame: Baseline, during and Immediately after the procedure
Systolic Blood Pressure as measured by the Empatica E4 wristband
Time frame: Baseline, during and Immediately after the procedure
Diastolic Blood Pressure as measured by the Empatica E4 wristband
Time frame: Baseline, during and Immediately after the procedure
Sympathetic skin response as measured by the Empatica E4 wristband
Time frame: Baseline, during and Immediately after the procedure
Temperature as measured by the Empatica E4 wristband
Time frame: Baseline, during and Immediately after the procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayed Wahezi, MD principal investigator
Albert Einstein College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Google Cardboard, Oculus and Lidocaine Hydrochloride in people with Pain, run by Albert Einstein College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity as measured by the Visual Analog Scale (time frame: Immediately after receiving spinal injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.