Clinical trial NCT04414501: Comparison of Virtual Reality to Tablet-based Distraction in Children
Official title: A Comparison of Virtual Reality Headset and Touch Screen Tablet for Minimizing Anxiety During Separation From Caregiver and Induction of Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety, Separation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 94
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study is a prospective randomized trial to be performed in pediatric patient's ages 4 to 10 years undergoing surgical procedures requiring general anesthesia. The purpose is to compare the effectiveness of interactive tablet devices vs. Virtual Reality headsets. The primary outcome measure being patient anxiety at the time of separation. Other comparison measures will include preoperative parent/caregiver anxiety, anesthesia mask acceptance characteristics at the time of induction, and time to fully recover in the post-operative period.

Detailed description: After receiving IRB approval from our institution and consent from parents or guardians, ASA I or II status children ages 4 - 10 presenting for surgery requiring general anesthesia were recruited for this study. They were assigned to either tablet- or VR-based groups. At our institution, tablet-based distraction is widely used and represents standard practice. Children in this control group were given tablets in the preoperative holding area before transport to the operating room. Content consisted of entertainment apps providing access to music videos, movies and games targeting various age groups.

The study group was given a Virtual Reality Smartphone headset in the preoperative holding area prior to transport to the operating room. This headset was chosen because of its low cost and wide compatibility for a variety of smartphones. The content consisted of several VR environments that the child/parent could choose from.

In both groups, the distraction with tablet or VR was continued throughout separation from caregivers, transport to the operating room, placement of monitors and mask induction of general anesthesia. Anxiety at time of separation was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI). Mask acceptance at induction of anesthesia was determined by using the Mask Acceptance Scale.

Eligibility criteria: Inclusion Criteria:

* Children 4-10 years of age
* Undergoing procedure that requires general anesthesia

Exclusion Criteria:

* Emergent procedure
* ASA III-IV
* Patients with facial skin lesions
* Patients with significant history of motion sickness
* Visually impaired patients
* Patients unable to wear a virtual reality headset
* Patients receiving pharmacological intervention to decrease preoperative anxiety

Primary outcomes:
measure: Patient anxiety at the time of separation in children before surgical procedures
timeFrame: Preoperative Period
Secondary outcomes:
measure: additional anxiety scoring techniques
timeFrame: Preoperative period
measure: Mask acceptance by the patient
timeFrame: Intraoperative period
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University
name: Elizabeth Ghazal, MD
role: PRINCIPAL_INVESTIGATOR
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