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Evaluating the Feasibility of VR for Pediatric Renal Biopsies

Primary Purpose

Pain, Procedural, Procedural Anxiety, Sedation Complication

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Samsung Gear Virtual Reality Headset

About this trial

This is an interventional treatment trial for Pain, Procedural

Eligibility Criteria

5 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UCSF Benioff Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VR Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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)

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)

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

Total Dose of Sedation Needed

Total dose (mg/kg) of pharmacologic sedation needed to complete renal biopsy with adequate patient analgesia, anxiolysis, and comfort

Full Information

NCT ID

NCT05267704

First Posted

October 7, 2021

Last Updated

November 28, 2022

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT05267704

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 11, 2022 (Actual)

Primary Completion Date

May 31, 2023 (Anticipated)

Study Completion Date

May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Procedural, Procedural Anxiety, Sedation Complication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VR Arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Samsung Gear Virtual Reality Headset

Intervention Description

VR headset displaying preselected game during renal biopsy

Primary Outcome Measure Information:

Title

Acceptability of VR to Patients/Families

Description

Time Frame

From arrival to procedural room to completion of procedure (~30 minutes)

Secondary Outcome Measure Information:

Title

Pre- and Post-Procedural Pain (Change in Observation Scale of Behavioral Distress Scale)

Description

Time Frame

From arrival to procedural room to completion of procedure (~30 minutes), at 15-second intervals

Title

Pre- and Post-Procedural Anxiety (Change in Childhood Anxiety Meter)

Description

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)

Time Frame

From arrival to procedural room to completion of procedure (~30 minutes)

Title

Pre- and Post-Procedural Anxiety (Change in Child Fear Scale)

Description

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)

Time Frame

From arrival to procedural room to completion of procedure (~30 minutes)

Title

Patient, Parent, and Provider Satisfaction (Post-procedure)

Description

Patient, parent, and provider satisfaction as assessed on 4-question Likert scale (0 to 5, with 5 being high satisfaction) survey

Time Frame

From arrival to procedural room to completion of procedure (~30 minutes)

Title

Total Dose of Sedation Needed

Description

Total dose (mg/kg) of pharmacologic sedation needed to complete renal biopsy with adequate patient analgesia, anxiolysis, and comfort

Time Frame

From arrival to procedural room to completion of procedure (~30 minutes)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Justin Libaw, MD, MPH

Phone

415-443-1366

justin.libaw@ucsf.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Omar Salman, MD

Phone

415-514-1815

omar.salman@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Justin Libaw, MD, MPH

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSF Benioff Children's Hospital

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Omar Salman, MD

Phone

415-514-1815

omar.salman@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32618627

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.

Results Reference

background

PubMed Identifier

34269867

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.

Results Reference

background

PubMed Identifier

32779029

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.

Results Reference

background

Links:

URL

https://www.samsung.com/global/galaxy/gear-vr/

Description

Samsung Gear VR Headset

Learn more about this trial

Evaluating the Feasibility of VR for Pediatric Renal Biopsies

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