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AI-Guided Stress Management Breathing Practices Via a Wearable Device

AI-Guided Stress Management Breathing Practices Using a Wearable Device: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06881875
Enrollment
120
Registered
2025-03-18
Start date
2025-03-15
Completion date
2025-12-31
Last updated
2025-03-18

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

Conditions

Stress Reduction

Keywords

stress reduction, breathing practices, wearable device, AI guided intervention

Brief summary

This study explores the effectiveness of AI-guided breathing practices for stress management in adults. In this randomized controlled trial, 120 participants will be recruited and assigned to an intervention group (n=90) or a control group (n=30). The study includes four brief breathing practices, guided by a wristband. The intervention group will interact with an AI chatbot to receive a personalized daily breathing plan for 28 days, adjusted weekly based on feedback. Meanwhile, the control group will practice progressive muscle relaxation daily. It is hypothesized that, the intervention group will have significantly improvements in stress management and emotion regulation skills compare to the control group. These group differences are expected to persist at 1-month, 3-month and 6-month follow-up assessment.

Interventions

BEHAVIORALAI-guided breathing practices

Participant will obtain a wristband with a built-in breathing practices program when assigned to the intervention group. Four kinds of breathing practices are included, which are bee breathing, diaphragmatic breathing, box breathing and 4-7-8 breathing. A specially prompted AI chat bot interviews the participant and designs a personalized daily breathing practice plan according to participant's preference and daily stress. Participant follows the plan in the following 28-day intervention period. Plan is adjusted weekly based on participant's feedback.

BEHAVIORALProgressive muscle relaxation

Participant practices progressive muscle relaxation for 5 minutes daily.

Sponsors

Peking University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

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

Inclusion criteria

1. Currently enrolled college students. 2. Aged between 18 and 30 years old.

Exclusion criteria

1. Current or past history of psychotic disorders. 2. Using contraceptives, cortisol, beta-blockers, antidepressants, or other psychiatric medications, as well as medications for chronic diseases during the intervention and follow-up periods.

Design outcomes

Primary

MeasureTime frameDescription
Perceived stressbaseline, daily for 28 days, post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeksThe investigators will explore the effectiveness of the AI-guided breathing practices on stress management using a self-developed stress questionnaire. The questionnaire consists of 15 items, each rated on a 5-point scale, with higher scores indicating greater perceived stress.
Emotionbaseline, daily for 28 days, post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeksThe investigators will explore the effectiveness of the AI-guided breathing practices on emotion using the positive and negative affect schedule(PANAS). The questionnaire consists of 20 items, each rated on a 5-point scale, with higher scores on the negative affect subscale indicating greater negative emotion, and higher scores on the positive affect subscale indicating greater positive emotion.

Secondary

MeasureTime frameDescription
Sleep qualitybaseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeksThe investigators will explore the effectiveness of the AI-guided breathing practices on enhancing sleep quality using the insomnia severity index(ISI). The questionnaire consists of 7 items, each rated on a 5-point scale, with higher scores indicating worse sleep quality.
Alexithymiabaseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeksThe investigators will explore the effectiveness of the AI-guided breathing practices on reducing alexithymia using a self-developed alexithymia questionnaire. The questionnaire consists of 23 items, each rated on a 5-point scale, with higher scores indicating greater alexithymia.
Irritationbaseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeksThe investigators will explore the effectiveness of the AI-guided breathing practices on reducing irritation using a self-developed irritation questionnaire. The questionnaire consists of 18 items, each rated on a 5-point scale, with higher scores indicating greater irritation.

Countries

China

Outcome results

None listed

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