Clinical trial NCT04125004: Use of Virtual Reality for Pediatric Minor Surgical Procedures
Official title: Evaluation of Technology-Based Distractions In Pediatric Patients During General Surgery Minor Procedures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Virtual Reality
General Anesthesia
Keywords: virtual reality
pediatric surgery
general anesthesia
distraction technique
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project is looking to use virtual reality for minor general surgery procedures in addition to local anesthesia instead of general anesthesia.

Detailed description: Study population. Patients ages 7-18 undergoing minor surgical procedures at Lucile Packard Children's Hospital will be recruited. Minor surgical procedures include hormone implant placement/removal/exchange, cecostomy tube exchange, incision and drainage of superficial soft tissue abscesses excluding the perineum and buttock, excision of benign masses \<2cm on the extremity (e.g. sebaceous cyst, pilomatricoma, lipoma, etc), and foreign body removal from superficial wounds. Exclusion criteria include those with significant cognitive impairment, history of motion sickness, history of seizures, Glasgow Coma Scale (GCS) \<15, currently taking anxiety medication or narcotics, facial trauma, clinically unstable or require urgent/emergent intubation, claustrophobia, and visual or auditory impairment. The investigators aim to enroll at least 200 patients into the study.

Intervention. Research coordinators will recruit patients and their families prior to their schedule procedures. Informed consent and assent will be obtained from participants and their caregivers when a patient is a minor. Demographic information will be collected from all participants. Patients will complete pre-procedural survey for pain and anxiety. Parents will complete a survey that documents their perception of their child's anxiety level. Patients will be randomly assigned to a treatment arm.

Patients assigned to the general anesthesia arm will have a child life specialist in the pre-procedural period per hospital routine. Anesthesia will be administered at the discretion of the anesthesiologist. Once the procedure is completed, the patient will recover and be monitored in the post-anesthesia care unit (PACU) per hospital guidelines.

Patients assigned to the virtual reality arm will be instructed on how to use the handheld system. A trained research coordinator or child life specialist will be with the patient during the procedure to help with any issues that may arise. They will document any interfering behaviors during the procedure. After the procedure, the patient will be monitored in the PACU per hospital guidelines.

All patients will complete the post-procedural survey for pain and anxiety. Patients, parents and the surgeon will also complete satisfaction surveys.

Eligibility criteria: Inclusion Criteria:

* less than 18 years of age
* parental consent/patient assent
* undergoing minor procedure(s)

Exclusion Criteria:

* participants and patients who do not consent
* have significant cognitive impairment
* have a history of severe motion sickness
* currently have nausea
* history of seizures or currently experiencing seizures
* have visual or auditory impairment
* clinically unstable or require urgent/emergent intervention and/or American Society of Anesthesiologist class 4 or 5
* history of claustrophobia
* Glasgow Coma Scale \<15
* currently taking anxiety medication
* currently taking narcotics
* facial trauma

Primary outcomes:
measure: Completion of procedure
timeFrame: 2 years
Secondary outcomes:
measure: Change in Children's Fear Scale
timeFrame: 2 years
measure: Pain Catastrophizing Scale for Parents
timeFrame: 2 years
measure: Change in Faces Pain Scale
timeFrame: 2 years
measure: Caregiver's satisfaction of procedure
timeFrame: 2 years
measure: Clinician Satisfaction Survey
timeFrame: 2 years
measure: Cost difference between general anesthesia and virtual reality
timeFrame: 2 years
measure: Change in Anxiety Scale
timeFrame: 2 years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Stephanie Chao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
citation: Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.