Use of Virtual Reality for Pediatric Minor Surgical Procedures

NCT ID: NCT04125004

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-08
• Study Completion Date: 2021-03-01

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.

Conditions

Virtual Reality; General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

virtual reality

Patients will use virtual reality headset during procedure

Group Type: EXPERIMENTAL

Samsung Virtual Reality Headset

Intervention Type: DEVICE

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

general anesthesia

Patients will undergo general anesthesia for their procedure

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Samsung Virtual Reality Headset

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Stephanie D. Chao

Assistant Professor of Pediatric Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Chao, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucile Packard Children's Hospital

Palo Alto, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21806301 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11427329 (View on PubMed)

Other Identifiers

52692

Identifier Type: -

Identifier Source: org_study_id