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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR Arm | Experimental | Pediatric patients age 5-17 using the VR headset during renal biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oculus Go Virtual Reality Headset | Device | VR headset displaying preselected game during renal biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures | 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 | From arrival to procedural room to completion of procedure (~30 minutes) |
| Number of Parents Who "Agreed" or "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures | 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 | From arrival to procedural room to completion of procedure (~30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Self-reported Procedural Anxiety (Change in Childhood Anxiety Meter) | 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. |
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Inclusion Criteria:
- Patients age 5-17 receiving a renal biopsy at the University of California, San Francisco (UCSF) Benioff Children's Hospital
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Libaw, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Benioff Children's Hospital | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32618627 | Background | 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. | |
| 34269867 | Background | 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. |
| Label | URL |
|---|---|
| Samsung Gear VR Headset | View source |
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Pediatric patients aged 5 to 17 years were the enrolled participants, as they were the only individuals who engaged with the virtual reality (VR) environment during renal biopsies. Caregivers provided informed consent for their child's participation, and assent was obtained from the child when appropriate. Caregivers and sedation providers completed brief surveys about their perceptions of the VR experience but were not themselves enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | VR Arm | Pediatric patients age 5-17 using the VR headset during renal biopsy. Samsung Gear Virtual Reality Headset: VR headset displaying preselected game during renal biopsy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VR Arm | Pediatric patients age 5-17 using the VR headset during renal biopsy. Participants included 8 children aged 5-8, 15 children aged 9-12, and 9 children aged 13-17 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures | 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 | Posted | Number | participants (patients) | From arrival to procedural room to completion of procedure (~30 minutes) |
|
From enrollment, during the renal biopsy, and until discharge from the hospital, up to 2 weeks depending on time of discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VR Arm | Pediatric patients age 5-17 using the VR headset during renal biopsy. |
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Limitations include selection bias for those who want to participate in VR experience and also the team's inability to blind participants/providers. In addition, the selection of an appropriate VR environment is challenging for various procedures and age groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Omar Salman, MD | University of California, San Francisco | 6159733909 | omar.salman@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2021 | Nov 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| From arrival to procedural room to completion of procedure (~30 minutes) |
| Mean Difference in Self-reported Procedural Anxiety (Change in Child Fear Scale) | 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. | From arrival to procedural room to completion of procedure (~30 minutes) |
| 32779029 | Background | 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Units |
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| Counts |
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| Participants |
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| Secondary | Mean Difference in Self-reported Procedural Anxiety (Change in Childhood Anxiety Meter) | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | From arrival to procedural room to completion of procedure (~30 minutes) |
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| Secondary | Mean Difference in Self-reported Procedural Anxiety (Change in Child Fear Scale) | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | From arrival to procedural room to completion of procedure (~30 minutes) |
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| Primary | Number of Parents Who "Agreed" or "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures | 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 | 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 | Posted | Number | participants (parents) | From arrival to procedural room to completion of procedure (~30 minutes) |
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| 32 |
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| 32 |
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