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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480724
Recruitment Status : Suspended (The IRB approval expired 05/21/2021)
First Posted : March 29, 2018
Last Update Posted : January 5, 2022
Sponsor:
Collaborator:
American Academy of Physical Medicine and Rehabilitation
Information provided by (Responsible Party):
Montefiore Medical Center

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

Detailed Description:

Group 1: Oculus Rift This group will receive BTI's per conventional protocols. They will wear the Oculus Rift VRHMD (Figure

1) 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.

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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
Actual Primary Completion Date : May 21, 2021
Estimated Study Completion Date : December 31, 2023

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



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



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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.

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
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United States, New York
E-MMC - Rehabilitation Medicine, The Arthur S. Abramson Department of
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
American Academy of Physical Medicine and Rehabilitation
Investigators
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Principal Investigator: Yuxi Chen, MD Albert Einstein College of Medicine
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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03480724    
Other Study ID Numbers: 2016-6501
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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