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NCT Number: NCT07127575

Scalable Intervention for Stress Management

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

Location status: Recruiting

Location contact

Milton Aguirre, PhD

CONTACT

[email protected]

7654960782

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistance Breathing Device

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

Electronic Resistance Breathing Device

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.

Primary outcomes

  1. Device Acceptability as Measured by the Acceptability of Intervention Measure (AIM)

    Time frame: 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.

  2. Device Usability as Measured by a Modified Version of the System Usability Scale (SUS)

    Time frame: 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 outcomes

  1. Perceived Stress as Measured by the Perceived Stress Scale (PSS_10)

    Time frame: From enrollment to the end of the 1 hour study period

    The 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.

  2. Physiological Stress as Assessed with Heart Rate Monitoring

    Time frame: From study enrollment to end of 1 hour study period

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Case, PhD

CONTACT

[email protected]

Milton E Aguirre, PhD

CONTACT

[email protected]

7654960782

Sponsors and collaborators

Lead sponsor

Livotion, LLC

Industry

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • Purdue University

Registry information

Official study title

A Scalable Intervention for Stress Management Practices

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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