Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diversion Device With Breath Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208984
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
University of Utah

Brief Summary:

The experience for many children who need to undergo anesthesia induction by breathing anesthetic vapors in the operating room is frightening to the child. We have developed a computer-based game system that uses breathing-in and breathing-out as a game controller. We believe that the immersive game experience will encourage breathing patterns ideal for anesthetic induction while providing fun and diversion for the child, lessening or eliminating the fear that typically accompanies breathing anesthetics.

The purpose of the study is to determine whether diversion and breathing encouragement offered by a game and this device


Condition or disease Intervention/treatment
Induction of Anesthesia Device: Study Other: Music Video

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interactive Multimedia Diversion Device With Breath Control
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Control
Patients randomized to this group will receive standard of care induction of anesthesia
Study
Patients randomized to this group will receive induction of anesthesia using the Lullabreath game
Device: Study
After consent and assent the child and parent will be introduced the Lullabreath in pre-op. The purpose of Lullabreath will be explained and the Lullabreath will be taught (15 minutes). The parent will complete the PROMIS Proxy Anxiety short form. The children are then taken to the operating room (leave parents) with the Lullabreath. The anesthesiologist will hook the device up to the anesthesia circuit and start the Lullabreath. The child will then undergo induction of anesthesia while playing the Lullabreath.

Music Video
Patients randomized to this group will receive induction of anesthesia using the music video game
Other: Music Video
After consent and assent the child and parent will be introduced to the game in pre-op. The purpose of the game will be explained and the game will be taught (15 minutes). The parent will complete the PROMIS Proxy Anxiety short form. The children are then taken to the operating room (leave parents) with the game. The anesthesiologist will hook the device up to the anesthesia circuit and start the game. The child will then undergo induction of anesthesia while playing the game. The child can choose to watch one of two music videos (Frozen, Lion King)




Primary Outcome Measures :
  1. Anxiety [ Time Frame: Administered to parents directly after induction of anesthesia ]
    Anxiety measured by the PROMIS Anxiety Parent-Proxy questionnaire, minimum 0, maximum 100 points (t-score), higher score means higher anxiety

  2. End-tidal oxygen at the beginning of anesthesia [ Time Frame: Measured directly after induction ]
    End-tidal oxygen concentration measured at the start of anesthesia

  3. Anxiety [ Time Frame: Administered to the anesthesiologist caring for the patient directly after induction of anesthesia ]
    Anxiety measured by the PROMIS Anxiety Parent-Proxy questionnaire, minimum 0, maximum 100 points (t-score), higher score means higher anxiety



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
4-11 year old children undergoing anesthesia for any procedure without visual impairment, non english speaking, Premature infants and children previously exposed to the chemotherapeutic agent bleomycin
Criteria

Inclusion Criteria:

  • 4-11 year old children undergoing anesthesia for any procedure

Exclusion Criteria:

  • Visual impairment
  • non english speaking
  • Premature infants
  • children previously exposed to the chemotherapeutic agent bleomycin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208984


Contacts
Layout table for location contacts
Contact: Ami Stuart, PhD 8017934800 ami.stuart@hsc.utah.edu

Locations
Layout table for location information
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Ami Stuart, PhD    801-793-4800    ami.stuart@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT04208984    
Other Study ID Numbers: 104924
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Utah:
induction
anesthesia
children