Impact of a Breath-controlled Video Game App

NCT04000646 | Completed

• 1 other identifier: 2019-0654
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Acute

Keywords

anxiety, children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Secondary aim (anxiety)

  Child preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured during induction)

• Secondary aim (anxiety)

  Parental preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured immediately after induction)

• Secondary aim (satisfaction)

  Immediatly after anesthesia induction

Study Arms (2)

standard care

OTHER

Standard care non-pharmacologic interventions during anesthesia induction

Other: standard care

breath-controlled app

EXPERIMENTAL

breath-controlled app and custom-designed tablet (equipped with a breathing sensor)

Other: breath-controlled app

Interventions

standard care OTHER

standard care non-pharmacologic interventions during anesthesia induction

standard care

breath-controlled app OTHER

breath-controlled app and custom-designed tablet (equipped with a breathing sensor)

breath-controlled app

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Abby Hess, DNP

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: June 27, 2019
• Study Start: June 26, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)