Impact of a Breath-controlled Video Game App

Children's Hospital Medical Center, Cincinnati55 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Anxiety Acute

Interventions

standard careOTHER

standard care non-pharmacologic interventions during anesthesia induction

breath-controlled appOTHER

breath-controlled app and custom-designed tablet (equipped with a breathing sensor)

Eligibility

Sex: ALLMin age: 3 YearsMax age: 8 Years

Medical Language ↔ Plain English

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

Locations (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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"

Time frame: During anesthesia induction

Secondary Outcomes

Secondary aim (anxiety)

Child anxiety (modified Yale Preoperative Anxiety Scale, the "mYPAS-SF"), scored 23-100, 100 = highest anxiety score

Time frame: 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

Time frame: 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)

Time frame: Immediatly after anesthesia induction

Data from ClinicalTrials.gov

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