Evaluating the Feasibility of VR for Pediatric Renal Biopsies

NCT ID: NCT05267704

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-11

Study Completion Date

2024-08-01

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.

Conditions

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Pain, Procedural Procedural Anxiety Sedation Complication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VR Arm

Pediatric patients age 5-17 using the VR headset during renal biopsy.

Group Type EXPERIMENTAL

Samsung Gear Virtual Reality Headset

Intervention Type DEVICE

VR headset displaying preselected game during renal biopsy

Interventions

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Samsung Gear Virtual Reality Headset

VR headset displaying preselected game during renal biopsy

Intervention Type DEVICE

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Libaw, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF Benioff Children's Hospital

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Justin Libaw, MD, MPH

Role: CONTACT

415-443-1366

Omar Salman, MD

Role: CONTACT

415-514-1815

Facility Contacts

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Omar Salman, MD

Role: primary

415-514-1815

References

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Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.

Reference Type BACKGROUND
PMID: 32618627 (View on PubMed)

Taylor JS, Chandler JM, Menendez M, Diyaolu M, Austin JR, Gibson ML, Portelli KI, Caruso TJ, Rodriguez S, Chao SD. Small surgeries, big smiles: using virtual reality to reduce the need for sedation or general anesthesia during minor surgical procedures. Pediatr Surg Int. 2021 Oct;37(10):1437-1445. doi: 10.1007/s00383-021-04955-6. Epub 2021 Jul 16.

Reference Type BACKGROUND
PMID: 34269867 (View on PubMed)

Goldman RD, Behboudi A. Virtual reality for intravenous placement in the emergency department-a randomized controlled trial. Eur J Pediatr. 2021 Mar;180(3):725-731. doi: 10.1007/s00431-020-03771-9. Epub 2020 Aug 10.

Reference Type BACKGROUND
PMID: 32779029 (View on PubMed)

Related Links

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Other Identifiers

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21-35095

Identifier Type: -

Identifier Source: org_study_id

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