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Scalable Intervention for Stress Management

A Scalable Intervention for Stress Management Practices

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07127575
Enrollment
60
Registered
2025-08-17
Start date
2025-08-01
Completion date
2025-09-30
Last updated
2025-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragmatic Breathing, Stress

Keywords

resistance breathing, stress management

Brief summary

The purpose of this research is to measure the acceptance of a resistance breathing intervention and to assess whether it produces physiological and subjective effects in a laboratory setting.

Detailed description

College students experience a wide range of stressors during their studies, with many students experiencing levels of stress that can be clinically significant, such as anxiety or depression. Counseling centers on college campuses have seen a rise in students seeking mental health support or stress relief, but there exists a discrepancy in the level of need versus the support that can be provided. Stress management interventions, such as self-care mobile applications and devices, have risen in popularity given their relative accessibility and implementation of stress relieving interventions such as regulated breathing. Regulated breathing has been shown to be a reliable and effective form of stress relief, however its implementation within various eHealth interventions and related devices can come into conflict when used in educational settings. Mobile apps and biofeedback devices (e.g., chest straps, inhalers), can be contextually inappropriate, cumbersome, and potentially stigmatizing for students. To overcome these barriers, the PI developed the AIRpen, a simple, affordable, multi-functional stress management device that is designed to fit into the fabric of students' lives to potentially optimize the delivery, practice, and fidelity of diaphragmatic breathing (DB) interventions in real- world settings. With anecdotal and empirical evidence supporting the device as feasible and acceptable in real-world academic settings, this study will build upon prior work and measure the acceptance of the intervention and assess whether using the original and a smart version of the device as a stress relieving tool produces physiological and subjective effects in a laboratory setting.

Interventions

DEVICEResistance Breathing Device

The AIRpen is a multifunctional stress management tool that helps users engage in diaphragmatic breathing at differing resistance levels, as well as other common stress relieving behaviors such as fidgeting

DEVICEElectronic Resistance Breathing Device

The Smart AIRpen functions just as the original AIRpen device and has been augmented with sensors to measure use patterns to determine whether the AIRpen is being used for fidgeting or breathing.

Sponsors

Purdue University
CollaboratorOTHER
National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Livotion, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants will be assigned to one of three conditions. 20 will be in the no pen condition, 20 will be in the original AIRpen condition, and 20 will be in the smart AIRpen condition.

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Be at least 18 years old * Be currently enrolled in a college or university * Be able to read, speak, and comprehend English * Be able and willing to complete a 60-minute study involving heart rate monitoring, survey completion, training, a stress test, and device utilization

Exclusion criteria

-Individuals diagnosed with anxiety or stress and require professional support to cope with these clinical levels of stress or anxiety should not enroll in the study in place of professional assistance.

Design outcomes

Primary

MeasureTime frameDescription
Device Acceptability as Measured by the Acceptability of Intervention Measure (AIM)From enrollment to end of 1 hour study period.The AIM measure is designed to assess the acceptability of a intervention, and has been adapted in relation to the AIRpen. Participants rate statements related to their usage and experience of the AIRpen and AIRpen website, with ratings ranging from Completely Disagree (1), to Completely Agree (5). Higher scores indicate higher acceptability of the intervention.
Device Usability as Measured by a Modified Version of the System Usability Scale (SUS)From enrollment until completion of 1 hour study period.The System Usability Scale is a 10-item measure that address the usability and learnability of a system. The SUS has been modified to reflect the AIRpen intervention. Statements are ranked on a Likert scale for 1-5, with 1 indicating Strongly Disagree and 5 indicating Strongly Agree. Raw scores are converted into a final score that ranges from 0-100, with a larger score indicating greater usability.

Secondary

MeasureTime frameDescription
Perceived Stress as Measured by the Perceived Stress Scale (PSS_10)From enrollment to the end of the 1 hour study periodThe Perceived Stress Scale is a measure used to assess perceptions of recent stress. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Physiological Stress as Assessed with Heart Rate MonitoringFrom study enrollment to end of 1 hour study period

Countries

United States

Contacts

Primary ContactMilton E Aguirre, PhD
meaguirr@purdue.edu7654960782
Backup ContactAmanda Case, PhD
amanda-case@uiowa.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026