Evaluating the Feasibility of VR for Pediatric Renal Biopsies

Pain, Procedural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05267704
• Other study ID #: 21-35095
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: November 2022
• Source: University of California, San Francisco
• Contact: Justin Libaw, MD, MPH
• Phone: 415-443-1366
• Email: justin.libaw[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Procedural
• Procedural Anxiety
• Sedation Complication

Intervention

Device:
• Samsung Gear Virtual Reality Headset
VR headset displaying preselected game during renal biopsy

Locations

Country	Name	City	State
United States	UCSF Benioff Children's Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From arrival to procedural room to completion of procedure (~30 minutes)
Secondary	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)	From arrival to procedural room to completion of procedure (~30 minutes), at 15-second intervals
Secondary	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)	From arrival to procedural room to completion of procedure (~30 minutes)
Secondary	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)	From arrival to procedural room to completion of procedure (~30 minutes)
Secondary	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	From arrival to procedural room to completion of procedure (~30 minutes)
Secondary	Total Dose of Sedation Needed	Total dose (mg/kg) of pharmacologic sedation needed to complete renal biopsy with adequate patient analgesia, anxiolysis, and comfort	From arrival to procedural room to completion of procedure (~30 minutes)

External Links

•   Samsung Gear VR Headset