Evaluating the Feasibility of VR for Pediatric Renal Biopsies

Not Applicable

Recruiting

• Conditions: Sedation Complication; Procedural Anxiety; Pain, Procedural
• Interventions: Device: Samsung Gear Virtual Reality Headset

• Registration Number: NCT05267704
• Lead Sponsor: University of California, San Francisco

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-04
• Study Start: 2022-10-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VR Arm	Samsung Gear Virtual Reality Headset	Pediatric patients age 5-17 using the VR headset during renal biopsy.

Primary Outcome Measures

Name	Time	Method
Acceptability of VR to Patients/Families	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

Name	Time	Method
Pre- and Post-Procedural Pain (Change in Observation Scale of Behavioral Distress Scale)	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)
Pre- and Post-Procedural Anxiety (Change in Childhood Anxiety Meter)	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)
Pre- and Post-Procedural Anxiety (Change in Child Fear Scale)	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)
Patient, Parent, and Provider Satisfaction (Post-procedure)	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
Total Dose of Sedation Needed	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

Trial Locations

Locations (1)

UCSF Benioff Children's Hospital; 🇺🇸 San Francisco, California, United States