Evaluating the Feasibility of VR for Pediatric Renal Biopsies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluating the Feasibility of Virtual Reality for Procedural Sedation in Pediatric Renal Biopsy Patients

Conditions
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Pain, Procedural, Procedural Anxiety, Sedation Complication

Intervention / Treatment
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* Device: Samsung Gear Virtual Reality Headset


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR Arm<br>Pediatric patients age 5-17 using the VR headset during renal biopsy. | Device: Samsung Gear Virtual Reality Headset<br>* VR headset displaying preselected game during renal biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of VR to Patients/Families | 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 | From arrival to procedural room to completion of procedure ( 30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre- and Post-Procedural Pain (Change in Observation Scale of Behavioral Distress Scale) | 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) | From arrival to procedural room to completion of procedure ( 30 minutes), at 15-second intervals | 
| Pre- and Post-Procedural Anxiety (Change in Childhood Anxiety Meter) | 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) | From arrival to procedural room to completion of procedure ( 30 minutes) | 
| Pre- and Post-Procedural Anxiety (Change in Child Fear Scale) | 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) | From arrival to procedural room to completion of procedure ( 30 minutes) | 
| Patient, Parent, and Provider Satisfaction (Post-procedure) | Patient, parent, and provider satisfaction as assessed on 4-question Likert scale (0 to 5, with 5 being high satisfaction) survey | From arrival to procedural room to completion of procedure ( 30 minutes) | 
| Total Dose of Sedation Needed | Total dose (mg/kg) of pharmacologic sedation needed to complete renal biopsy with adequate patient analgesia, anxiolysis, and comfort | From arrival to procedural room to completion of procedure ( 30 minutes) |