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Clinical Trials/NCT04125004
NCT04125004WithdrawnNot Applicable

Evaluation of Technology-Based Distractions In Pediatric Patients During General Surgery Minor Procedures

Stanford University1 site in 1 countryStarted: January 8, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Completion of procedure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
7 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

virtual reality

Experimental

Patients will use virtual reality headset during procedure

Intervention: Samsung Virtual Reality Headset (Device)

general anesthesia

No Intervention

Patients will undergo general anesthesia for their procedure

Outcomes

Primary Outcomes

Completion of procedure

Time Frame: 2 years

Can the procedure be completed without general anesthesia or procedure sedation. Surgeons will be provided with a self-report survey documenting completion of the procedure. This will be assessed by the surgeon completing the procedure who will answer via questionnaire.

Secondary Outcomes

  • Change in Children's Fear Scale(2 years)
  • Change in Anxiety Scale(2 years)
  • Clinician Satisfaction Survey(2 years)
  • Cost difference between general anesthesia and virtual reality(2 years)
  • Pain Catastrophizing Scale for Parents(2 years)
  • Change in Faces Pain Scale(2 years)
  • Caregiver's satisfaction of procedure(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stephanie D. Chao

Assistant Professor of Pediatric Surgery

Stanford University

Study Sites (1)

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