Impact of a Breath-controlled Video Game App

Study Overview
=================
Brief Summary
-----------------
The proposed research study will assess the impact of a newly developed, breath-controlled app and custom-designed tablet (equipped with a breathing sensor) on the patient and parent's preoperative anxiety and anesthesia induction experience.

Detailed Description
-----------------
Aim 1: Determine whether induction distress differs between patients using the breathing-controlled app and those using standard care interventions: The investigators will measure patient compliance with induction using the Child Induction Behavioral Assessment (CIBA). The investigators predict that patients using the breathing-controlled app will demonstrate significantly better induction compliance. Older children (ages 6-8) are typically more cooperative with induction than younger children (ages 3-5 years). Both age groups will be studied to determine whether there are age-related differences impacting receptiveness to the app. Aim 2: Compare patient anxiety between the breath-controlled app and control group. The investigators will measure child preoperative anxiety (modified Yale Preoperative Anxiety Scale, the mYPAS-SF). The investigators predict there will be significantly lower anxiety (mYPAS-SF) during induction for children in the breath-controlled app group. Aim 3: Compare parent anxiety between the breath-controlled app and control group. The investigators will measure parental anxiety using the Visual Analog Scale for Anxiety, the VAS-A. The investigators predict there will be significantly lower anxiety (mYPAS-SF) during induction for parents in the breath-controlled app group. Aim 4: Determine overall family satisfaction with the induction experience. A survey will be administered to assess satisfaction levels with induction behavioral interventions and determine whether these scores differ between the intervention and standard care group. The investigators predict that satisfaction scores will be higher in the intervention group than the control group.

Official Title
-----------------
Impact of a Breath-controlled Video Game App on Preoperative Anxiety, Induction Behavior and Parent Experience: A Randomized Controlled Trial

Conditions
-----------------
Anxiety Acute

Intervention / Treatment
-----------------
* Other: standard care
* Other: breath-controlled app


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting to Same Day Surgery department at CCHMC Liberty campus Outpatient or 23 hour admission Any surgery or procedure under anesthesia Ages 3 to 8 years Male or female Any ethnicity American Society of Anesthesiologists (ASA) physical classification status I or II Patient has never had a prior anesthetic Family and participant communicate primarily in English & signed English anesthesia consent Normal neurocognitive development Patient is undergoing inhalation induction using an anesthesia mask Parent/guardian is present for induction Patient does not receive a premedication for anxiety Exclusion Criteria: Neurocognitive delays Developmental delays/Behavioral diagnoses, such as (but not limited to) ADHD, Autism, Oppositional defiant disorder, Obsessive Compulsive Disorder, Anxiety disorder Patient takes medications routinely for behavioral issues Tracheostomy Inpatient or planned >23 hour admission

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: standard care<br>Standard care non-pharmacologic interventions during anesthesia induction | Other: standard care<br>* standard care non-pharmacologic interventions during anesthesia induction<br>|
| Experimental: breath-controlled app<br>breath-controlled app and custom-designed tablet (equipped with a breathing sensor) | Other: breath-controlled app<br>* breath-controlled app and custom-designed tablet (equipped with a breathing sensor)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary aim (induction distress) | Induction distress (Child induction behavioral assessment tool, the CIBA), scored by reviewing behavioral descriptions of 3 categories, Smooth, Moderate, or Difficult | During anesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary aim (anxiety) | Child anxiety (modified Yale Preoperative Anxiety Scale, the mYPAS-SF), scored 23-100, 100 = highest anxiety score | Child preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured during induction) | 
| Secondary aim (anxiety) | Parental anxiety (Visual Analog Scale for anxiety, the VAS-A), scored 0-100, 100 = highest anxiety score | Parental preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured immediately after induction) | 
| Secondary aim (satisfaction) | Family satisfaction with the induction experience (survey, Likert scale, 1= poor; 10 = excellent) | Immediatly after anesthesia induction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, children