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Evaluating the Feasibility of VR for Pediatric Renal Biopsies

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ClinicalTrials.gov Identifier: NCT05267704
Recruitment Status : Recruiting
First Posted : March 4, 2022
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
The purpose of this study is to assess the use of virtual reality (VR) as an adjunct or alternative to pharmacologic sedation in pediatric patients undergoing renal biopsy.

Condition or disease Intervention/treatment Phase
Pain, Procedural Procedural Anxiety Sedation Complication Device: Samsung Gear Virtual Reality Headset Not Applicable

Detailed Description:
Children aged 5-17 scheduled for renal biopsy will be offered the option to use a virtual reality (VR) headset that displays an interactive game as part of their renal biopsy experience. The standard of care of sedation medications will still be available to patients who are unable to complete the procedure with only the VR headset without pharmacologic sedation. Pain and anxiety will be monitored continuously using validated scales by a pediatric hospitalist and sedation nurse. These providers, as well as patients and parents, may ask for additional medications for adequate analgesia and anxiolysis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Feasibility of Virtual Reality for Procedural Sedation in Pediatric Renal Biopsy Patients
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: VR Arm
Pediatric patients age 5-17 using the VR headset during renal biopsy.
 Device: Samsung Gear Virtual Reality Headset
VR headset displaying preselected game during renal biopsy


Outcome Measures
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Primary Outcome Measures :
  1. Acceptability of VR to Patients/Families [ Time Frame: From arrival to procedural room to completion of procedure (~30 minutes) ]
    Acceptability of VR as non-pharmacologic sedation based on a team-made Likert scale survey given to patients, parents, and providers (Likert scale, with 1 = "strongly disagree" as most dissatisfied with VR experience and 5 = "strongly agree" as most satisfied with VR experience and a better perceived outcome


Secondary Outcome Measures :
  1. Pre- and Post-Procedural Pain (Change in Observation Scale of Behavioral Distress Scale) [ Time Frame: From arrival to procedural room to completion of procedure (~30 minutes), at 15-second intervals ]
    Pain as recorded on Observation Scale of Behavioral Distress (OSBD 11 point behavioral scale rating the number and intensity of distress behaviors demonstrated before/during/after the procedure in 15-second intervals; higher scores and intensity of distress behaviors indicate worse pain)

  2. Pre- and Post-Procedural Anxiety (Change in Childhood Anxiety Meter) [ Time Frame: From arrival to procedural room to completion of procedure (~30 minutes) ]
    Anxiety as recorded on Childhood Anxiety Meter (CAM 0-10 scale, using analogy of mercury thermometer to ask children to rate level of anxiety, with higher score indicating more anxiety)

  3. Pre- and Post-Procedural Anxiety (Change in Child Fear Scale) [ Time Frame: From arrival to procedural room to completion of procedure (~30 minutes) ]
    Children's Fear Scale (CFS 0-4 scale, visual face scale correlated with 0-4 numeric scale, with 4 being highest fear/anxiety related to procedure)

  4. Patient, Parent, and Provider Satisfaction (Post-procedure) [ Time Frame: From arrival to procedural room to completion of procedure (~30 minutes) ]
    Patient, parent, and provider satisfaction as assessed on 4-question Likert scale (0 to 5, with 5 being high satisfaction) survey

  5. Total Dose of Sedation Needed [ Time Frame: From arrival to procedural room to completion of procedure (~30 minutes) ]
    Total dose (mg/kg) of pharmacologic sedation needed to complete renal biopsy with adequate patient analgesia, anxiolysis, and comfort


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Patients age 5-17 receiving a renal biopsy at the University of California, San Francisco (UCSF) Benioff Children's Hospital

Exclusion Criteria:

  • Patients who cannot lie supine for their renal biopsy will be excluded from the study
  • Patients with injuries to the head/face that would prohibit wearing a headset
  • Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
  • Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
  • Patients with a history of or current symptoms of vertigo
  • Patients who are blind
  • Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver
  • Patients on whom the VR headset does not fit appropriately
Contacts and Locations
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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): NCT05267704


Contacts
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Contact: Justin Libaw, MD, MPH 415-443-1366 justin.libaw@ucsf.edu
Contact: Omar Salman, MD 415-514-1815 omar.salman@ucsf.edu

Locations
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United States, California
UCSF Benioff Children's Hospital Recruiting
San Francisco, California, United States, 94143
Contact: Omar Salman, MD    415-514-1815    omar.salman@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Justin Libaw, MD, MPH University of California, San Francisco
More Information
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Additional Information:

Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05267704    
Other Study ID Numbers: 21-35095
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: March 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: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pain, Procedural
Pain
Neurologic Manifestations