Impact of a Breath-controlled Video Game App

Not Applicable

Completed

• Conditions: Anxiety Acute
• Interventions: Other: standard care; Other: breath-controlled app

• Registration Number: NCT04000646
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study First Submitted: 2019-06-23
• Study Start: 2019-06-26
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Status Verified: 2021-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care	standard care	Standard care non-pharmacologic interventions during anesthesia induction
breath-controlled app	breath-controlled app	breath-controlled app and custom-designed tablet (equipped with a breathing sensor)

Primary Outcome Measures

Name	Time	Method
Primary aim (induction distress)	During anesthesia induction	Induction distress (Child induction behavioral assessment tool, the "CIBA"), scored by reviewing behavioral descriptions of 3 categories, "Smooth, "Moderate", or "Difficult"

Secondary Outcome Measures

Name	Time	Method
Secondary aim (anxiety)	Parental preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured immediately after induction)	Parental anxiety (Visual Analog Scale for anxiety, the "VAS-A"), scored 0-100, 100 = highest anxiety score
Secondary aim (satisfaction)	Immediatly after anesthesia induction	Family satisfaction with the induction experience (survey, Likert scale, 1= poor; 10 = excellent)

Trial Locations

Locations (1)

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States