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Completed

NCT Number: NCT05267704

Evaluating the Feasibility of VR for Pediatric Renal Biopsies

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.

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Key information

Conditions

Pain, Procedural Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Procedural Anxiety Sedation Complication Signs and Symptoms

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oculus Go Virtual Reality Headset

Device

VR headset displaying preselected game during renal biopsy

Primary outcomes

  1. 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

  2. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2022
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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