An interventional study of Oculus Go Virtual Reality Headset in Pain, Procedural, Procedural Anxiety and Sedation Complication, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 5 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
237 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's enrollment of 32 is below the median of 83 across 223 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
- Patients age 5-17 receiving a renal biopsy at the University of California, San Francisco (UCSF) Benioff Children's Hospital
Exclusion Criteria:
Pediatric patients age 5-17 using the VR headset during renal biopsy.
Device: Oculus Go Virtual Reality Headset
VR headset displaying preselected game during renal biopsy
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
Time frame: 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
Time frame: From arrival to procedural room to completion of procedure (~30 minutes)
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.
Time frame: 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.
Time frame: From arrival to procedural room to completion of procedure (~30 minutes)
| Milestone | VR Arm |
|---|---|
| Started | 32 |
| Completed | 32 |
| Not completed | 0 |
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
| participants (patients) | VR Arm |
|---|---|
| Agree | 0 |
| Strongly Agree | 32 |
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.
| score on a scale | VR Arm |
|---|---|
| Mean Difference in Self-reported Procedural Anxiety (Change in Childhood Anxiety Meter) | 3.47 (2.47 to 4.46) |
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.
| score on a scale | VR Arm |
|---|---|
| Mean Difference in Self-reported Procedural Anxiety (Change in Child Fear Scale) | 1.47 (1.09 to 1.85) |
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
| participants (parents) | VR Arm |
|---|---|
| Agree | 3 |
| Strongly Agree | 29 |
Collected over From enrollment, during the renal biopsy, and until discharge from the hospital, up to 2 weeks depending on time of discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VR Arm | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Categorical(Participants) | VR Arm |
|---|---|
| <=18 years | 32 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | VR Arm |
|---|---|
| Female | 17 |
| Male | 15 |
| Race and Ethnicity Not Collected(Participants) | VR Arm |
|---|
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University of California, San Francisco