Clinical trial NCT05267704: Evaluating the Feasibility of VR for Pediatric Renal Biopsies
Official title: Evaluating the Feasibility of Virtual Reality for Procedural Sedation in Pediatric Renal Biopsy Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Procedural
Procedural Anxiety
Sedation Complication
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of VR to Patients/Families
timeFrame: From arrival to procedural room to completion of procedure (~30 minutes)
Secondary outcomes:
measure: Pre- and Post-Procedural Pain (Change in Observation Scale of Behavioral Distress Scale)
timeFrame: From arrival to procedural room to completion of procedure (~30 minutes), at 15-second intervals
measure: Pre- and Post-Procedural Anxiety (Change in Childhood Anxiety Meter)
timeFrame: From arrival to procedural room to completion of procedure (~30 minutes)
measure: Pre- and Post-Procedural Anxiety (Change in Child Fear Scale)
timeFrame: From arrival to procedural room to completion of procedure (~30 minutes)
measure: Patient, Parent, and Provider Satisfaction (Post-procedure)
timeFrame: From arrival to procedural room to completion of procedure (~30 minutes)
measure: Total Dose of Sedation Needed
timeFrame: From arrival to procedural room to completion of procedure (~30 minutes)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Justin Libaw, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.