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

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ClinicalTrials.gov Identifier: NCT03480724
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
American Academy of Physical Medicine and Rehabilitation
Information provided by (Responsible Party):
Yuxi Chen, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE April 14, 2017
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date February 21, 2021
Actual Study Start Date  ICMJE July 6, 2017
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
Severity of Pain Measurement [ Time Frame: About 20 minutes per patient. ]
Measurement of pain using the Face, Legs, Activity, Cry, Consolability scale (FLACC) for all subjects.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
Measurement of severity of anxiety [ Time Frame: About 20 minutes per patient ]
Measurement of anxiety using Short State-Trait Anxiety Inventory (STAI) Anxiety scale.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control
Official Title  ICMJE Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control During Botox Injections for Spasticity Management: A Randomized Control Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Pain
Intervention  ICMJE
  • Other: Google Cardboard VRA
    Intervention was randomized and shuffled.
  • Other: Oculus Rift VRA
    Intervention was randomized and shuffled.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Google Cardboard VRA
  • Active Comparator: Oculus Rift VRA
    This group of subjects will receive VRA with Oculus Rift
    Intervention: Other: Oculus Rift VRA
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03480724
Other Study ID Numbers  ICMJE 2016-6501
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yuxi Chen, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE American Academy of Physical Medicine and Rehabilitation
Investigators  ICMJE Not Provided
PRS Account Montefiore Medical Center
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP