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OpenTrials
Completed

NCT Number: NCT04000646

Impact of a Breath-controlled Video Game App

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.

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care

Other

standard care non-pharmacologic interventions during anesthesia induction

breath-controlled app

Other

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

Primary outcomes

  1. 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"

Secondary outcomes

  1. 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

  2. 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

  3. Secondary aim (satisfaction)

    Time frame: Immediatly after anesthesia induction

    Family satisfaction with the induction experience (survey, Likert scale, 1= poor; 10 = excellent)

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 27, 2019
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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