Health TrialsbyHealthPanel

Scalable Intervention for Stress Management

ConditionsStressDiaphragmatic Breathing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorLivotion, LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Base AIRpenExperimental treatment 1 intervention
Group B: Smart AIRpenExperimental treatment 1 intervention
Group C: No AIRpenNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
From enrollment to end of 1 hour study period.
2

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

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.

Time frame
From enrollment until completion of 1 hour study period.

Secondary outcomes

1

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

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.

Time frame
From enrollment to the end of the 1 hour study period
2

Physiological Stress as Assessed with Heart Rate Monitoring

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Livotion, LLC

Lead sponsor

Purdue University

Collaborator

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
Apply now