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NCT04414501 Clinical Trial

Comparison of Virtual Reality to Tablet-based Distraction in Children

Anxiety, Separation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04414501
Other study ID # 5180036
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 30, 2018
Est. completion date April 2, 2020

Study information
Verified date March 2021
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

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Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Separation Anxiety
Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.

Locations
Country Name City State
United States Loma Linda University Medical Center Loma Linda California

Sponsors (1)
Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (16)

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Outcome
Type Measure Description Time frame Safety issue
Primary Patient anxiety at the time of separation in children before surgical procedures We will compare modified Yale Preoperative Anxiety Scale (mYPAS) scores between the tablet based distraction group to those in virtual reality group. The mYPAS evaluates 27 items divided into 5 categories: activity, vocalization, emotional expressivity, state of arousal, and use of parent. The score ranges from 23 (low anxiety) to 100 (high anxiety). Preoperative Period
Secondary additional anxiety scoring techniques Short State-Trait Anxiety Inventory for Adults (STAI). The STAI is a validated self-evaluation questionnaire measuring anxiety with scores ranging from 6 (not at all) to 24 (very much). Preoperative period
Secondary Mask acceptance by the patient Mask Acceptance Scores Intraoperative period
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