Evaluating the Feasibility of VR for Pediatric Renal Biopsies

University of California, San Francisco20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain, Procedural Procedural Anxiety Sedation Complication

Interventions

Samsung Gear Virtual Reality HeadsetDEVICE

VR headset displaying preselected game during renal biopsy

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UCSF Benioff Children's Hospital

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: From arrival to procedural room to completion of procedure (~30 minutes)

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Central Contacts

Justin Libaw, MD, MPH

CONTACT

415-443-1366 justin.libaw@ucsf.edu

Omar Salman, MD

CONTACT

415-514-1815 omar.salman@ucsf.edu

Data from ClinicalTrials.gov

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