Anxiety Acute
Conditions
Keywords
anxiety, children
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.
Interventions
OTHERstandard care
standard care non-pharmacologic interventions during anesthesia induction
OTHERbreath-controlled app
breath-controlled app and custom-designed tablet (equipped with a breathing sensor)
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary aim (anxiety) | Child preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured during induction) | Child anxiety (modified Yale Preoperative Anxiety Scale, the mYPAS-SF), scored 23-100, 100 = highest anxiety score |
| Secondary aim (satisfaction) | Immediatly after anesthesia induction | Family satisfaction with the induction experience (survey, Likert scale, 1= poor; 10 = excellent) |
Countries
United States
Outcome results
None listed