Anxiety AcuteNCT04000646
Impact of a Breath-controlled Video Game App
A study of Anxiety Acute, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Anxiety Acute
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety Acute
- Being tested
- standard care, breath-controlled app
- Keywords
- anxiety, children
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard careOther
standard care non-pharmacologic interventions during anesthesia induction
breath-controlled appOther
breath-controlled app and custom-designed tablet (equipped with a breathing sensor)
| Study group | Role | What they receive |
|---|---|---|
| standard care | Other | Standard care non-pharmacologic interventions during anesthesia induction Receives: Other: standard care |
| breath-controlled app | Experimental | breath-controlled app and custom-designed tablet (equipped with a breathing sensor) Receives: Other: breath-controlled app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: During anesthesia induction
Secondary outcomes (3)
Secondary aim (anxiety)
Child anxiety (modified Yale Preoperative Anxiety Scale, the "mYPAS-SF"), scored 23-100, 100 = highest anxiety score
Measured: Child preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured during induction)
Secondary aim (anxiety)
Parental anxiety (Visual Analog Scale for anxiety, the "VAS-A"), scored 0-100, 100 = highest anxiety score
Measured: Parental preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured immediately after induction)
Secondary aim (satisfaction)
Family satisfaction with the induction experience (survey, Likert scale, 1= poor; 10 = excellent)
Measured: Immediatly after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start26 Jun 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety AcuteStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abby Hess, DNP, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000646
- Sponsor's protocol ID
- 2019-0654
- Status last verified
- Jan 2021
- First submitted
- 23 Jun 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Breath-controlled Video Game App on Preoperative Anxiety, Induction Behavior and Parent Experience: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04000646
- Acronym / sponsor ID
- 2019-0654
- Conditions
- Anxiety Acute
- Keywords
- anxiety, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| standard care | Other | Other: standard careStandard care non-pharmacologic interventions during anesthesia induction |
| breath-controlled app | Experimental | Other: breath-controlled appbreath-controlled app and custom-designed tablet (equipped with a breathing sensor) |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard carestandard care non-pharmacologic interventions during anesthesia induction | Other | standard care |
| breath-controlled appbreath-controlled app and custom-designed tablet (equipped with a breathing sensor) | Other | breath-controlled app |
Primary outcome
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"
3 secondary outcomes
Secondary aim (anxiety)
Time frame: 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)
Secondary aim (satisfaction)
Time frame: Immediatly after anesthesia induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abby Hess, DNP principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Anxiety Acute, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary aim (induction distress) (time frame: During anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.