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Diversion Device With Breath Control

NCT04208984 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2026-04-01

No results posted yet for this study

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

Interventions

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.

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)

Sponsors & Collaborators

Principal Investigators

  • Kai Kuck, PhD · University of Utah

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04208984 on ClinicalTrials.gov