PainPEDSPAINVRNCT03480724
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control
A study testing Google Cardboard VRA and Oculus Rift VRA in people with Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
To evaluate the efficacy of virtual reality analgesia (VRA) for pediatric patients undergoing Botulinum toxin injections (BTI) for spasticity management. Patients will be assigned to one of three groups; one group of subjects will randomly be assigned to VRA intervention using Google Cardboard Virtual reality head… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Pain
- What is being tested?
- Google Cardboard VRA and Oculus Rift VRA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2017to 27 Oct 2023
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with spasticity requiring BTI
- Children ages 5 - 18
- Children who have contraindications for sedation for BTI
- Children with intact vision who can attend VR intervention
Who cannot join
- Children who have uncontrolled seizures > than 4 per year
- Children who are not attentive to VR secondary to poor concentration, poor cognition to external stimuli
- Children on different treatments for spasticity such as baclofen pump, phenol block. For patients who receive phenol block, phenol block will be held during the visits with VR intervention to avoid confounding results
- Children with poor bleeding control
- Children who request general anesthesia/IV sedation.
Trial locations and contacts
1 site in 1 country.
United States1 site
E-MMC - Rehabilitation Medicine, The Arthur S. Abramson Department of
The Bronx, New York, 10467
About this study
Official title: Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control During Botox Injections for Spasticity Management: A Randomized Control Trial
To evaluate the efficacy of virtual reality analgesia (VRA) for pediatric patients undergoing Botulinum toxin injections (BTI) for spasticity management. Patients will be assigned to one of three groups; one group of subjects will randomly be assigned to VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch, a second group of subjects will receive VRA with Oculus Rift, and a third group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group.
Read the detailed description
Group 1: Oculus Rift This group will receive BTI's per conventional protocols. They will wear the Oculus Rift VRHMD (Figure
- powered by the laptop pc (Figure 2) during the procedure viewing a VR 360 degree video of their choice. Measurements in pain and anxiety will be taken per the outcome measures listed above.
Group 2: Google Cardboard VRHMD This group will receive BTI's per conventional protocols. They will wear the Google cardboard VRHMD (Figure 3) powered by iPod touch/smartphone (Figure 4) during the procedure viewing a VR 360 degree video of their choice. Measurements in pain and anxiety will be taken per the outcome measures listed above.
Group 3. Control This group will receive BTI's per conventional protocols without VRA intervention.
- Conditions
- Pain
- Being tested
- Google Cardboard VRA, Oculus Rift VRA
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Google Cardboard VRAOther
Intervention was randomized and shuffled.
Oculus Rift VRAOther
Intervention was randomized and shuffled.
| Study group | Role | What they receive |
|---|---|---|
| Google Cardboard VRA | Active comparator | This group of subjects will receive VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch. Receives: Other: Google Cardboard VRA |
| Oculus Rift VRA | Active comparator | This group of subjects will receive VRA with Oculus Rift Receives: Other: Oculus Rift VRA |
| Control | No intervention | This group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Pain Measurement
Measurement of pain using the Face Legs Activity Cry Consolability scale (FLACC scale) which is a Behavioral Pain Assessment Scale. Each category is scored on the 0-2 scale, that results in total score of 0-10.
0= Relaxed and comfortable , 1-3 = Mild discomfort, 4-6=Moderate pain, 7-10= Severe discomfort or pain or both. Lower score is a good outcome and higher score is a bad outcome. The assessment is for all the subjects in the study.
Measured: About 20 minutes per patient.
Secondary outcomes (1)
Measurement of severity of anxiety
Measurement of anxiety using Short State-Trait Anxiety Inventory (STAI) Anxiety scale which is a self-evaluation questionnaire completed by the patient's parent or guardian about how they feel and how the child feels at that moment.
It consists of 6 questions each having scale 1-4. 1 being Not at all and 4 being Very much. The questions are as follows:
- I feel calm
- I am tense
- I feel upset
- I am relaxed
- I feel content
- I am worried
Measured: About 20 minutes per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start6 Jul 2017
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Why it stopped: Despite efforts no additional participants were able to be enrolled since March 2020.
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.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups of patients One group with no VR One group with Oculus rift VR One group with google cardboard box VR
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Physical Medicine and Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Yuxi Chen, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480724
- Sponsor's protocol ID
- 2016-6501
- Acronym
- PEDSPAINVR
- Status last verified
- Jan 2024
- First submitted
- 14 Apr 2017
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control During Botox Injections for Spasticity Management: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03480724
- Acronym / sponsor ID
- PEDSPAINVR / 2016-6501
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Despite efforts no additional participants were able to be enrolled since March 2020.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- American Academy of Physical Medicine and Rehabilitation
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 29 Mar 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.
To evaluate the efficacy of virtual reality analgesia (VRA) for pediatric patients undergoing Botulinum toxin injections (BTI) for spasticity management. Patients will be assigned to one of three groups; one group of subjects will randomly be assigned to VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch, a second group of subjects will receive VRA with Oculus Rift, and a third group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group.
Detailed description
Group 1: Oculus Rift This group will receive BTI's per conventional protocols. They will wear the Oculus Rift VRHMD (Figure
- powered by the laptop pc (Figure 2) during the procedure viewing a VR 360 degree video of their choice. Measurements in pain and anxiety will be taken per the outcome measures listed above.
Group 2: Google Cardboard VRHMD This group will receive BTI's per conventional protocols. They will wear the Google cardboard VRHMD (Figure 3) powered by iPod touch/smartphone (Figure 4) during the procedure viewing a VR 360 degree video of their choice. Measurements in pain and anxiety will be taken per the outcome measures listed above.
Group 3. Control This group will receive BTI's per conventional protocols without VRA intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 groups of patients One group with no VR One group with Oculus rift VR One group with google cardboard box VR
| Arm | Type | Receives |
|---|---|---|
| Google Cardboard VRA | Active comparator | Other: Google Cardboard VRAThis group of subjects will receive VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch. |
| Oculus Rift VRA | Active comparator | Other: Oculus Rift VRAThis group of subjects will receive VRA with Oculus Rift |
| Control | No intervention | –This group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children with spasticity requiring BTI
- Children ages 5 - 18
- Children who have contraindications for sedation for BTI
- Children with intact vision who can attend VR intervention
Key exclusion criteria (5 listed)
- Children who have uncontrolled seizures > than 4 per year
- Children who are not attentive to VR secondary to poor concentration, poor cognition to external stimuli
- Children on different treatments for spasticity such as baclofen pump, phenol block. For patients who receive phenol block, phenol block will be held during the visits with VR intervention to avoid confounding results
- Children with poor bleeding control
- Children who request general anesthesia/IV sedation.
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 Cardboard VRAIntervention was randomized and shuffled. | Other | Google Cardboard VRA |
| Oculus Rift VRAIntervention was randomized and shuffled. | Other | Oculus Rift VRA |
Primary outcome
Severity of Pain Measurement
Time frame: About 20 minutes per patient.
Measurement of pain using the Face Legs Activity Cry Consolability scale (FLACC scale) which is a Behavioral Pain Assessment Scale. Each category is scored on the 0-2 scale, that results in total score of 0-10. 0= Relaxed and comfortable , 1-3 = Mild discomfort, 4-6=Moderate pain, 7-10= Severe discomfort or pain or both. Lower score is a good outcome and higher score is a bad outcome. The assessment is for all the subjects in the study.
1 secondary outcome
Measurement of severity of anxiety
Time frame: About 20 minutes per patient
Results and safety
The study was stopped early (reason given: Despite efforts no additional participants were able to be enrolled since March 2020.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Yuxi Chen, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Google Cardboard VRA and Oculus Rift VRA in people with Pain, run by Montefiore Medical Center at 1 site in United States.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: Despite efforts no additional participants were able to be enrolled since March 2020.). Results are not available in the source record.
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?
Severity of Pain Measurement (time frame: About 20 minutes per patient.). 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 5 Jan 2024.