Feasibility of the Gamification of Incentive Spirometry in Trauma Patients

NCT ID: NCT06090279

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-07-31

Brief Summary

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Gamification may be one solution that can increase the compliance in the use of devices like incentive spirometry.

Detailed Description

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Recently, there has been much interest in the gamification of healthcare, such as virtual incentive spirometry gaming. Several studies have examined the addition of gamification e.g. virtual incentive spirometry devices. There is a paucity of data regarding the gamification of incentive spirometry, and there is no data involving trauma patients. Previous studies have enrolled either healthy volunteers or patients with specific lung pathology. This study to assess the safety, feasibility and efficacy of respiratory interventions in chest trauma patients using a therapeutic gamification platform.

Conditions

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Thoracic Trauma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

a minimum of 3 rounds of game usage in the Trauma Intensive Care Unit (TICU). Each patient will receive at least 2 sessions per day.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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OmniFlow Breathing Therapy BioFeeback System

This system is a FDA approved healthcare gaming system that is used for patients who have difficulty breathing and allows the patients to participate in breathing exercises for pulmonary rehab.

Group Type EXPERIMENTAL

OmniFlow Breathing Therapy BioFeeback System

Intervention Type DEVICE

FDA approved healthcare gaming system that is used for patients who have difficulty breathing and allows the patients to participate in breathing exercises for pulmonary rehab. Each game usage itself is expected to last 15-20 minutes.

Interventions

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OmniFlow Breathing Therapy BioFeeback System

FDA approved healthcare gaming system that is used for patients who have difficulty breathing and allows the patients to participate in breathing exercises for pulmonary rehab. Each game usage itself is expected to last 15-20 minutes.

Intervention Type DEVICE

Other Intervention Names

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healthcare gaming

Eligibility Criteria

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Inclusion Criteria

* Patients will be included if informed consent can be obtained from patient themselves and first session of incentive spirometry gamification can be performed within 48 hours of Trauma Intensive Care Unit (TICU) admission
* Adult patients (≥ 18 years of age) in the TICU with rib fractures or flail segment or a sternal fracture

Exclusion Criteria

* Trauma patients in the TICU who are mechanically ventilated or requiring bilevel positive airway pressure (BiPAP)
* Glasgow Coma Scale (GCS) \< 15, at the time of enrollment
* Facial fractures precluding the use of incentive spirometry
* Any organ injury that precludes use of respiratory therapies in the clinical judgement of the clinical team
* Patients who are expected to be transferred out of the TICU or discharged from the TICU in the next 24 hours based on treating physicians judgment
* Patients who are transitioning to palliative care or expected to die in the next 48 hours based on treating physician's judgment will not be included
* Patients unable to consent for themselves
* Patients unable to use the mouthpiece of the Omniflow system, and those who have visual or hearing impairments that could limit their ability to evaluate the games
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aarti Sarwal, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Other Identifiers

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IRB00097144

Identifier Type: -

Identifier Source: org_study_id

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