Diversion Device With Breath Control

NCT04208984 | Withdrawn

• 1 other identifier: 104924
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Induction of Anesthesia

Keywords

induction; anesthesia; children

Outcome Measures

Primary Outcomes (3)

• Anxiety

  Anxiety measured by the PROMIS Anxiety Parent-Proxy questionnaire, minimum 0, maximum 100 points (t-score), higher score means higher anxiety

  Administered to parents directly after induction of anesthesia

• End-tidal oxygen at the beginning of anesthesia

  End-tidal oxygen concentration measured at the start of anesthesia

  Measured directly after induction

• Anxiety

  Anxiety measured by the PROMIS Anxiety Parent-Proxy questionnaire, minimum 0, maximum 100 points (t-score), higher score means higher anxiety

  Administered to the anesthesiologist caring for the patient directly after induction of anesthesia

Study Arms (3)

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

Music Video

Patients randomized to this group will receive induction of anesthesia using the music video game

Other: Music Video

Interventions

Study DEVICE

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.

Study

Music Video OTHER

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)

Music Video

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• year old children undergoing anesthesia for any procedure

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Study Officials

• Kai Kuck, PhD

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: January 31, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)