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Clinical Trials/NCT05267704
NCT05267704
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country32 target enrollmentOctober 11, 2022

Overview

Phase
Not Applicable
Intervention
Oculus Go Virtual Reality Headset
Conditions
Pain, Procedural
Sponsor
University of California, San Francisco
Enrollment
32
Locations
1
Primary Endpoint
Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 11, 2022
End Date
September 10, 2024
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

VR Arm

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

Intervention: Oculus Go Virtual Reality Headset

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Mean Difference in Self-reported Procedural Anxiety (Change in Childhood Anxiety Meter)(From arrival to procedural room to completion of procedure (~30 minutes))
  • Mean Difference in Self-reported Procedural Anxiety (Change in Child Fear Scale)(From arrival to procedural room to completion of procedure (~30 minutes))

Study Sites (1)

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