Impact of a Breath-controlled Video Game App

January 26, 2021 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: standard care
Standard care non-pharmacologic interventions during anesthesia induction
Other: standard care
standard care non-pharmacologic interventions during anesthesia induction
Experimental: breath-controlled app
breath-controlled app and custom-designed tablet (equipped with a breathing sensor)
Other: breath-controlled app
breath-controlled app and custom-designed tablet (equipped with a breathing sensor)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary aim (induction distress)
Time Frame: During anesthesia induction
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary aim (anxiety)
Time Frame: 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
Child preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured during induction)
Secondary aim (anxiety)
Time Frame: Parental preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured immediately after induction)
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 aim (satisfaction)
Time Frame: Immediatly after anesthesia induction
Family satisfaction with the induction experience (survey, Likert scale, 1= poor; 10 = excellent)
Immediatly after anesthesia induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital Medical Center, Cincinnati

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abby Hess, DNP, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-0654

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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