Use of Virtual Reality for Pediatric Minor Surgical Procedures

NCT04125004 | Withdrawn

• 1 other identifier: 52692
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Virtual Reality; General Anesthesia

Keywords

virtual reality; pediatric surgery; general anesthesia; distraction technique

Outcome Measures

Primary Outcomes (1)

• Completion of procedure

  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.

  2 years

Secondary Outcomes (7)

• Change in Children's Fear Scale

  2 years

• Pain Catastrophizing Scale for Parents

  2 years

• Change in Faces Pain Scale

  2 years

• Caregiver's satisfaction of procedure

  2 years

• Clinician Satisfaction Survey

  2 years

Study Arms (2)

virtual reality

EXPERIMENTAL

Patients will use virtual reality headset during procedure

Device: Samsung Virtual Reality Headset

general anesthesia

NO INTERVENTION

Patients will undergo general anesthesia for their procedure

Interventions

Samsung Virtual Reality Headset DEVICE

Patients will pick a game or feature from the virtual reality headset to use during their procedure

virtual reality

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 21806301 BACKGROUND

• 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.

  PMID: 11427329 BACKGROUND

Study Officials

• Stephanie Chao, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatric Surgery

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: October 14, 2019
• Study Start: January 8, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)