Evaluating the Feasibility of VR for Pediatric Renal Biopsies

March 10, 2026 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Benioff Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR Arm
Pediatric patients age 5-17 using the VR headset during renal biopsy.
Device: Oculus Go Virtual Reality Headset
VR headset displaying preselected game during renal biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures
Time Frame: From arrival to procedural room to completion of procedure (~30 minutes)
Acceptability of VR as non-pharmacologic sedation was assessed based on a team-made Likert scale survey given to patients and parents (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)
Number of Parents Who "Agreed" or "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures
Time Frame: From arrival to procedural room to completion of procedure (~30 minutes)
Acceptability of VR as non-pharmacologic sedation was assessed based on a team-made Likert scale survey given to patients and parents (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
Mean Difference in Self-reported Procedural Anxiety (Change in Childhood Anxiety Meter)
Time Frame: From arrival to procedural room to completion of procedure (~30 minutes)
Anxiety as recorded on the Childhood Anxiety Meter was assessed at the start of the procedure and after the procedure was completed with the VR experience. CAM is recorded on a 0-10 scale using an analogy of mercury thermometer to ask children to their rate level of anxiety, with a higher score indicating a greater level anxiety.
From arrival to procedural room to completion of procedure (~30 minutes)
Mean Difference in Self-reported Procedural Anxiety (Change in Child Fear Scale)
Time Frame: From arrival to procedural room to completion of procedure (~30 minutes)
Anxiety as recorded on the Children's Fear Scale was assessed at the start of the procedure and after the procedure was completed with the VR experience. CFS is recorded on a 0-4 numeric scale, with 4 being the highest fear/anxiety related to the procedure.
From arrival to procedural room to completion of procedure (~30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Justin Libaw, MD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Actual)

September 8, 2024

Study Completion (Actual)

September 10, 2024

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

March 3, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-35095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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