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Virtual Reality During Procedures in Pediatric Patients

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: NCT03686176
Recruitment Status : Terminated (Coronavirus (COVID-19)-related pause on all clinical research studies.)
First Posted : September 26, 2018
Results First Posted : July 28, 2020
Last Update Posted : August 6, 2020
Sponsor:
Collaborator:
The Thomas Wilson Sanitarium for Children of Baltimore City
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This stratified, randomized, controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department.

Condition or disease Intervention/treatment Phase
Virtual Reality Pediatrics Other: Virtual Reality Not Applicable

Detailed Description:

Pediatric emergency rooms and hospitals are anxiety provoking and often painful places for pediatric patients and families. Children of all ages 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. The standard of care to reduce pain and improve coping during pediatric procedures ranges from no intervention to support from child life specialists.

As an adjunct to the existing methods of promoting comfort during painful procedures, 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.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. No studies to date have used objective outcome measures of coping, which may be more clinically meaningful.

The investigators propose to fill this gap in the literature with a randomized, controlled, un-blinded study of coping and distress between virtual reality engagement and child life support in pediatric patients undergoing painful medical procedures.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, unblinded, controlled
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Reality During Procedures in Pediatric Patients
Actual Study Start Date : July 5, 2019
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : March 30, 2020

Arm Intervention/treatment
Experimental: Virtual Reality Group (Study Group)
In this arm, patients will receive support from child life specialists plus may use virtual reality simulation goggles during a qualifying medical procedure.
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

No Intervention: Active Control Group
In this arm, patients will receive standard of care with child life specialists plus distraction of the child's choosing, during a qualifying medical procedure.
No Intervention: External Control (Reference Group)
No virtual reality and no child life specialists; no standardized or formal form of support.



Primary Outcome Measures :
  1. Change in Patient-Reported Pain During the Procedure [ Time Frame: Baseline and Immediately post-procedure, up to 15 minutes ]
    Pain described on visual analog scale (0-10), or Wong-Faces Scale (0-10) with 0 being no pain and 10 being worst pain. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure.

  2. Change in Patient-Reported Anxiety During Procedure [ Time Frame: Baseline and Immediately post-procedure, up to 15 minutes ]
    Patient anxiety after procedures was described on a visual analog scale (0-10). This is a scale of range 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure.

  3. Change in Adult Perceived Pain During the Procedure [ Time Frame: Baseline and Immediately post-procedure, up to 15 minutes ]
    Perceived pain ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least pain and 10 representing the most. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. This measure was assessed in caregivers.

  4. Change in Adult Perceived Anxiety During the Procedure [ Time Frame: Baseline and Immediately post-procedure, up to 15 minutes ]
    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 in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers.

  5. Change in Adult's Own Anxiety During the Procedure [ Time Frame: Baseline and Immediately post-procedure, up to 15 minutes ]
    Anxiety ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least anxiety and 10 representing the most. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers.

  6. Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score [ Time Frame: Immediately post-procedure, up to 15minutes ]

    Coping was measured using a modified CAMPIS-SF in both patients and caregivers.

    CAMPIS-SF (Child-Adult Medical Procedure Interaction Scale-Short Form) is a behavior rating scale that documents distressing or coping behaviors exhibited in both children and the accompanying adult (parent/guardian). It has been validated to measure coping in children and adults during medical procedures. The CAMPIS-SF study used a 5-point Likert scale to document frequency of each code In order to account for frequency variance due to differences in procedure duration, we used a proportion-based metric validated for CAMPIS-R, and applied this to CAMPIS-SF codes. Proportions were calculated by summing the total number of an event type (e.g. child distress) and dividing by the total number of coded events (child distress plus child coping). This provided a proportion for each event type so that the proportion of child distress plus child coping events add up to 1.0 (range 0-1.0).



Secondary Outcome Measures :
  1. Duration of Procedure [ Time Frame: Immediately post-procedure, up to 20 minutes ]
    Duration of procedure in minutes will be assessed for each procedure.

  2. Ease of Procedure as Assessed by a Likert Scale [ Time Frame: Immediately post-procedure, up to 15 minutes ]
    Ease of procedure will be assessed using a Likert scale completed by proceduralist. The Likert scale ranges from 0-10 with 0 being easy and 10 difficult.

  3. Personnel Use for Immobilization [ Time Frame: Immediately post-procedure, up to 15 minutes ]
    This will be assessed using number of patients requiring immobilization during procedures.

  4. Number of IV or Phlebotomy Attempts [ Time Frame: Immediately post-procedure, up to 15 minutes ]
    Number of IV or phlebotomy attempts until success will be counted (1 or 2+) in patients undergoing venipuncture procedures.

  5. Pre-Procedure Nausea Symptoms [ Time Frame: Immediately pre-procedure (15minutes) ]
    The number of patients reporting nausea symptoms prior to the procedure

  6. Pre-Procedure Cybersickness Symptoms [ Time Frame: Immediately pre-procedure (15minutes) ]
    Number of patients in the VR group reporting positive cybersickness symptoms prior to the procedure



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Ages Eligible for Study:   7 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03686176


Locations
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United States, Maryland
Johns Hopkins Children's Center
Baltimore, Maryland, United States, 21212
Sponsors and Collaborators
Johns Hopkins University
The Thomas Wilson Sanitarium for Children of Baltimore City
Investigators
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Principal Investigator: Therese Canares, MD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03686176    
Other Study ID Numbers: IRB00161331
First Posted: September 26, 2018    Key Record Dates
Results First Posted: July 28, 2020
Last Update Posted: August 6, 2020
Last Verified: July 2020
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