Pain, Procedural, Procedural Anxiety, Sedation Complication
Conditions
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.
Interventions
DEVICEOculus Go Virtual Reality Headset
VR headset displaying preselected game during renal biopsy
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Self-reported Procedural Anxiety (Change in Childhood Anxiety Meter) | 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. |
| Mean Difference in Self-reported Procedural Anxiety (Change in Child Fear Scale) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJustin Libaw, MD, MPH
University of California, San Francisco
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 32 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
None listed