Impact of a Breath-controlled Video Game App
Primary Purpose
Anxiety Acute
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard care
breath-controlled app
Sponsored by
About this trial
This is an interventional other trial for Anxiety Acute focused on measuring anxiety, children
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
Sites / Locations
- Cincinnati Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
standard care
breath-controlled app
Arm Description
Standard care non-pharmacologic interventions during anesthesia induction
breath-controlled app and custom-designed tablet (equipped with a breathing sensor)
Outcomes
Primary Outcome Measures
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"
Secondary Outcome Measures
Secondary aim (anxiety)
Child anxiety (modified Yale Preoperative Anxiety Scale, the "mYPAS-SF"), scored 23-100, 100 = highest anxiety score
Secondary aim (anxiety)
Parental anxiety (Visual Analog Scale for anxiety, the "VAS-A"), scored 0-100, 100 = highest anxiety score
Secondary aim (satisfaction)
Family satisfaction with the induction experience (survey, Likert scale, 1= poor; 10 = excellent)
Full Information
NCT ID
NCT04000646
First Posted
June 23, 2019
Last Updated
January 26, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT04000646
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Acute
Keywords
anxiety, children
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard care
Arm Type
Other
Arm Description
Standard care non-pharmacologic interventions during anesthesia induction
Arm Title
breath-controlled app
Arm Type
Experimental
Arm Description
breath-controlled app and custom-designed tablet (equipped with a breathing sensor)
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Description
standard care non-pharmacologic interventions during anesthesia induction
Intervention Type
Other
Intervention Name(s)
breath-controlled app
Intervention Description
breath-controlled app and custom-designed tablet (equipped with a breathing sensor)
Primary Outcome Measure Information:
Title
Primary aim (induction distress)
Description
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 Outcome Measure Information:
Title
Secondary aim (anxiety)
Description
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)
Title
Secondary aim (anxiety)
Description
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)
Title
Secondary aim (satisfaction)
Description
Family satisfaction with the induction experience (survey, Likert scale, 1= poor; 10 = excellent)
Time Frame
Immediatly after anesthesia induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abby Hess, DNP
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of a Breath-controlled Video Game App
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