Low-intensity soothing music for anxiety in adolescents and young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants aged 18–25 with anxiety will be exposed to low-intensity soothing music and to control environmental sounds while researchers continuously record cortical hemodynamics using functional near-infrared spectroscopy (fNIRS) and heart rate/HRV with a wearable smart band. Self-reported symptoms and acoustic voice features will be collected via a digital mental health screening platform and all participants must provide written informed consent. Outcomes will compare immediate changes in cerebral blood flow patterns and autonomic markers between music and control conditions. The protocol excludes individuals with major somatic or neurological illnesses to reduce confounding physiological signals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants experiencing anxiety episodes were adolescents aged 18-25 years with a Generalized Anxiety Disorder-7 (GAD-7) score ≥ 5;
* Participants completed self-report symptom assessments via a digital mental health screening platform, alongside the collection of acoustic voice features, heart rate, and functional near-infrared spectroscopy (fNIRS) data;
* All participants were required to provide written informed consent;

Exclusion Criteria:

* History of major somatic illnesses, particularly those potentially associated with brain tissue alterations, such as hypertension, diabetes, or metastatic tumors; unstable physical conditions, including severe asthma; and a history of neurological abnormalities, including significant head trauma (loss of consciousness lasting more than five minutes), epilepsy, cerebrovascular disease, brain tumors, and neurodegenerative disorders;
* Somatic conditions that may induce mood disorder symptoms, such as multiple sclerosis or thyroid disorders;
* IQ below 70;
* Autism spectrum disorder (ASD) or pervasive developmental disorder (PDD);
* Participants with significant substance abuse or dependence within the three months preceding enrollment were excluded;
* Participants at high risk for suicide or with a prior history of suicide attempts were excluded;

Where it's running

• Hainan Medical University
  Haikou, Hainan, China Recruiting

Study contacts

• Study coordinator: Yue Zhu, Phd
• Email: zhuyuemiiu@163.com
• Phone: 86-18640197059

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.