Clinical trial NCT04000646: Impact of a Breath-controlled Video Game App
Official title: Impact of a Breath-controlled Video Game App on Preoperative Anxiety, Induction Behavior and Parent Experience: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Acute
Keywords: anxiety, children
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 55
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Primary aim (induction distress)
timeFrame: During anesthesia induction
Secondary outcomes:
measure: Secondary aim (anxiety)
timeFrame: Child preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured during induction)
measure: Secondary aim (anxiety)
timeFrame: Parental preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured immediately after induction)
measure: Secondary aim (satisfaction)
timeFrame: Immediatly after anesthesia induction
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Abby Hess, DNP
role: PRINCIPAL_INVESTIGATOR
References: