Impact of a Breath-controlled Video Game App

Anxiety Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000646
• Other study ID #: 2019-0654
• Status: Completed
• Phase: N/A
• Start date: June 26, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: January 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Acute
• Anxiety Disorders

Intervention

Other:
• standard care
standard care non-pharmacologic interventions during anesthesia induction
• breath-controlled app
breath-controlled app and custom-designed tablet (equipped with a breathing sensor)

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	Secondary aim (satisfaction)	Family satisfaction with the induction experience (survey, Likert scale, 1= poor; 10 = excellent)	Immediatly after anesthesia induction