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Virtual Reality During Procedures in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT03686176
Recruitment Status : Not yet recruiting
First Posted : September 26, 2018
Last Update Posted : August 27, 2019
Sponsor:
Collaborator:
The Thomas Wilson Sanitarium for Children of Baltimore City
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE September 26, 2018
Last Update Posted Date August 27, 2019
Estimated Study Start Date  ICMJE November 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • Patient-reported Pain during the procedure [ Time Frame: Immediately post-procedure (15minutes) ]
    Pain described on visual analog scale (0-10), or Wong-Faces Scale (0-10) with 0 being no pain and 10 being worst pain.
  • Anxiety as assessed by the subjective units of distress scale [ Time Frame: Immediately post-procedure (15minutes) ]
    The Subjective Units of Distress scale will be used to measure anxiety of subjects after procedures. This is a scale of 0-10 with 0 being no anxiety and 10 being maximum anxiety.
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • Patient-reported Pain during the procedure [ Time Frame: Immediately post-procedure (15mins) ]
    Pain described on visual analog scale (0-10), or Wong-Faces Scale (0-10) with 0 being no pain and 10 being worst pain.
  • Anxiety as assessed by the subjective units of distress scale [ Time Frame: Immediately post-procedure (15mins) ]
    The Subjective Units of Distress scale will be used to measure anxiety of subjects after procedures. This is a scale of 0-10 with 0 being no anxiety and 10 being maximum anxiety.
Change History Complete list of historical versions of study NCT03686176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • Duration of procedure [ Time Frame: Immediately post-procedure (15minutes) ]
    Duration of procedure in minutes will be assessed for each procedure.
  • Dosage of adjunct medications [ Time Frame: Immediately post-procedure (15minutes) ]
    Dosage of medications in mg given for pain will be measured.
  • Tolerance of procedure as assessed by a Likert scale [ Time Frame: Immediately post-procedure (15minutes) ]
    Tolerance of procedure will be assessed using a Likert scale completed by procedurist, child life, parent. The Likert scale ranges from 1-5 with 1 being the least tolerable and 5 being most tolerable.
  • Ease of completing procedure as assessed by a Likert scale [ Time Frame: Immediately post-procedure (15minutes) ]
    Ease of completing procedure will be assessed by a Likert scale which will be completed by procedurist. The scale ranges from 1-5 with 1 being difficult and 5 being easiest.
  • Personnel use for immobilization [ Time Frame: Immediately post-procedure (15minutes) ]
    This will be assessed using number of people needed to immobilize a subject, Likert scale of level of pressure applied, and wrapping during a procedure. The Likert scale ranges from 1-5 with 1 being least amount of pressure applied and 5 being maximum amount of pressure applied.
  • Number of IV or phlebotomy attempts [ Time Frame: Immediately post-procedure (15minutes) ]
    Number of IV or phlebotomy attempts until success will be counted(1, 2, 3, etc)
  • Cybersickness as assessed by the simulator Sickness Questionnaire [ Time Frame: Immediately post-procedure (15minutes) ]
    The presence of Cybersickness after a procedure will be assessed using the simulator Sickness Questionnaire. The questionnaire has 16 symptoms with each symptom being scored from 0-3. This will yield scores ranging from 0 to 48 with higher scores being higher severity of Cybersickness.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • Duration of procedure [ Time Frame: Immediately post-procedure (15mins) ]
    Duration of procedure in minutes will be assessed for each procedure.
  • Dosage of adjunct medications [ Time Frame: Immediately post-procedure (15mins) ]
    Dosage of medications in mg given for pain will be measured.
  • Tolerance of procedure as assessed by a Likert scale [ Time Frame: Immediately post-procedure (15mins) ]
    Tolerance of procedure will be assessed using a Likert scale completed by procedurist, child life, parent. The Likert scale ranges from 1-5 with 1 being the least tolerable and 5 being most tolerable.
  • Ease of completing procedure as assessed by a Likert scale [ Time Frame: Immediately post-procedure (15mins) ]
    Ease of completing procedure will be assessed by a Likert scale which will be completed by procedurist. The scale ranges from 1-5 with 1 being difficult and 5 being easiest.
  • Personnel use for immobilization [ Time Frame: Immediately post-procedure (15mins) ]
    This will be assessed using number of people needed to immobilize a subject, Likert scale of level of pressure applied, and wrapping during a procedure. The Likert scale ranges from 1-5 with 1 being least amount of pressure applied and 5 being maximum amount of pressure applied.
  • Number of IV or phlebotomy attempts [ Time Frame: Immediately post-procedure (15mins) ]
    Number of IV or phlebotomy attempts until success will be counted(1, 2, 3, etc)
  • Cybersickness as assessed by the simulator Sickness Questionnaire [ Time Frame: Immediately post-procedure (15mins) ]
    The presence of Cybersickness after a procedure will be assessed using the simulator Sickness Questionnaire. The questionnaire has 16 symptoms with each symptom being scored from 0-3. This will yield scores ranging from 0 to 48 with higher scores being higher severity of Cybersickness.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality During Procedures in Pediatric Patients
Official Title  ICMJE Virtual Reality During Procedures in Pediatric Patients
Brief Summary

Pediatric emergency rooms and hospitals are anxiety provoking and often painful places for pediatric patients and families. Children, ages 1 day to 22 years, present to the Johns Hopkins emergency room and are admitted to the hospital for a wide range of medical conditions, many of which require medical interventions. Many of these interventions are the source of anxiety and pain, including burn debridement or dressing changes, laceration repair, or intravenous (IV) line placement. In order to mitigate anxiety and pain; sedation, distraction, child life support, analgesia, and other methods are routinely employed. Medical anxiolysis and analgesia are often effective, typically using benzodiazepines, opiates, and/or ketamine, however these medications include risks and side effects. Also, with the growing opioid epidemic, there is a shift in clinical practice to decrease the reliance on narcotics. Thus, there is a growing urgency for non-narcotic methods of pain and anxiety reduction.

As an adjunct to the existing methods of anxiolysis and analgesia, non-invasive virtual reality (VR) therapy is showing promise as a means of distraction and coping with various medical procedures. The user is transported into a relaxing/distracting VR environment that diverts user's attention away from pain and anxiety. VR has demonstrated efficacy in the reduction of pain and anxiety experienced by individuals undergoing anxiety and pain inducing procedures. Based on existing data in adults and small pediatric populations, the investigators believe that the use of virtual reality simulations and games will decrease pediatric patient pain and anxiety related to painful procedures across multiple hospital settings and procedure types. Virtual reality therapy may also lead to decreased use of opiates, increased patient safety, no increase in procedure time, improved perceived procedure tolerance, and overall increase in patient and parent satisfaction. VR therapy has the potential to revolutionize the standard of care in pediatric procedural anxiolysis and analgesia.

While there is early data from small or narrow populations that show some improvement in pain and anxiety with VR use during pediatric procedures, some studies show no improvement. The investigators propose to fill this gap in the literature with a randomized, controlled, un-blinded study of virtual reality simulation compared to standard care in pediatric patients undergoing painful medical procedures.

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:
randomized, unblinded, controlled
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Virtual Reality
  • Pediatrics
Intervention  ICMJE Other: Virtual Reality
A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.
Other Name: Oculus Go
Study Arms  ICMJE
  • Experimental: Virtual Reality Group (Study Group)
    In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure.
    Intervention: Other: Virtual Reality
  • No Intervention: Standard Care (Control Group)
    In this arm, patients will receive standard of care during a qualifying medical procedure.
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 25, 2018)
176
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pediatric patients requiring painful or anxiety inducing procedures:

    • Burn debridement
    • Burn dressing change
    • Lactation repair
    • Intravenous (IV) line placement or phlebotomy (blood draw)
    • Abscess incision and drainage
    • Fracture reduction and/or cast placement
    • Implanted central venous port placement accessing
    • Skin biopsies
  2. Subjects ages 7 to 26 years of age (age 26 is the upper limit treated at JHCC) Ages were chosen based on that previously published in the literature on pediatric patients with VR.

Exclusion Criteria:

  • Patients with a known history of a seizure disorder.
  • Patients with an active infection, burn, or trauma that interferes with the mask placement, and may include involvement of the periorbital skin, eyes, nasal bridge, external ear, and/or scalp or hair.
  • Patients with Blindness.
  • Developmental delay significant enough to interfere with the subject's ability to participate in the session, including autism spectrum disorders.
  • Patients with active psychosis or exhibit signs of active intoxication.
  • Known history of severe motion sickness
  • Medical urgency (at the medical providers' discretion)
  • Non-verbal children
  • Children or parents/legal guardians who are non-English speakers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 26 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Therese Canares 443.287.1724 tcanare1@jhmi.edu
Contact: IRB Helpdesk 410-502-2092 jhmeirb@jhmi.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03686176
Other Study ID Numbers  ICMJE IRB00161331
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE The Thomas Wilson Sanitarium for Children of Baltimore City
Investigators  ICMJE
Principal Investigator: Therese Canares, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date August 2019

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