Pain, Procedural Clinical Trial
Official title:
Evaluating the Feasibility of Virtual Reality for Procedural Sedation in Pediatric Renal Biopsy Patients
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Benioff Children's Hospital | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | From arrival to procedural room to completion of procedure (~30 minutes) | |
Secondary | 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) | From arrival to procedural room to completion of procedure (~30 minutes), at 15-second intervals | |
Secondary | 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) | From arrival to procedural room to completion of procedure (~30 minutes) | |
Secondary | 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) | From arrival to procedural room to completion of procedure (~30 minutes) | |
Secondary | 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 | From arrival to procedural room to completion of procedure (~30 minutes) | |
Secondary | Total Dose of Sedation Needed | Total dose (mg/kg) of pharmacologic sedation needed to complete renal biopsy with adequate patient analgesia, anxiolysis, and comfort | From arrival to procedural room to completion of procedure (~30 minutes) |
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