Impact of a Breath-controlled Video Game App
Completed · Not applicable
Conditions studied: Anxiety Acute
In brief
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.
Key facts
- Study ID
- NCT04000646
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 55
- Starts
- 2019-06-26
- Expected to finish
- 2021-01-01
- Last updated by the study team
- 2021-01-29
Who can join
Age: 3 and older, up to 8. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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