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

The Effects of Low-Intensity Music on Brain-Heart Function in Adolescents With Anxiety

We will try low-intensity soothing music to see if it lowers heart rate and changes brain blood flow in 18–25-year-olds with anxiety.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 25 Years
• Sex: All
• Sponsor: Jiangsu Province Nanjing Brain Hospital (Academic / other)
• Locations: 1 site (Haikou, Hainan)
• Trial ID: NCT07492472 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are 18–25-year-olds experiencing anxiety with a GAD-7 score of 5 or higher who can consent and undergo fNIRS and wearable heart-rate monitoring.

Not a fit: People with major medical conditions (for example hypertension, diabetes), significant neurological disorders, or unstable physical illness are excluded and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could offer a non-drug way to reduce anxiety-related heart rate and improve brain blood flow regulation in young people.

How similar studies have performed: Previous smaller studies have shown that soothing music can reduce sympathetic activity and heart rate, but applying fNIRS in this adolescent/young-adult population is relatively novel.

Eligibility criteria

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 this trial is running

Haikou, Hainan

• Hainan Medical University — Haikou, Hainan, China (Recruiting)

Study contacts

• Study coordinator: Yue Zhu, Phd

Conditions Anxiety; Music Therapy