Anxiety, Separation
Conditions
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.
Interventions
BEHAVIORALSeparation Anxiety
Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient anxiety at the time of separation in children before surgical procedures | Preoperative Period | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| additional anxiety scoring techniques | Preoperative period | 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). |
| Mask acceptance by the patient | Intraoperative period | Mask Acceptance Scores |
Countries
United States
Outcome results
None listed