COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control (PEDSPAINVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480724
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : December 17, 2019
Sponsor:
Collaborator:
American Academy of Physical Medicine and Rehabilitation
Information provided by (Responsible Party):
Yuxi Chen, Montefiore Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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- 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.

Condition or disease Intervention/treatment Phase
Pain Other: Google Cardboard VRA Other: Oculus Rift VRA Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: The outcome accessor will have no patient contact and will not have access to the information on the type of intervention study patients were given.
Primary Purpose: Treatment
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
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Google Cardboard VRA
This group of subjects will receive VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch.
 Other: Google Cardboard VRA
Intervention was randomized and shuffled.
Active Comparator: Oculus Rift VRA
This group of subjects will receive VRA with Oculus Rift
 Other: Oculus Rift VRA
Intervention was randomized and shuffled.
No Intervention: Control
This group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Measurement of severity of anxiety [ Time Frame: About 20 minutes per patient ]

    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:

    1. I feel calm
    2. I am tense
    3. I feel upset
    4. I am relaxed
    5. I feel content
    6. I am worried


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480724


Locations
Layout table for location information
United States, New York
E-MMC - Rehabilitation Medicine, The Arthur S. Abramson Department of Recruiting
Bronx, New York, United States, 10467
Contact: Yuxi Chen, M.D    718-920-2283    yuchen@montefiore.org   
Contact: Matthew Bartels, M.D,MPH    (718) 920-2751    mbartels@montefiore.org   
Principal Investigator: Yuxi Chen, M.D         
Sub-Investigator: Erosa Stephen         
Sub-Investigator: Jared Ruben Levin, MD         
Sponsors and Collaborators
Montefiore Medical Center
American Academy of Physical Medicine and Rehabilitation
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yuxi Chen, Assistant Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03480724    
Other Study ID Numbers: 2016-6501
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No