The Effects of Low-Intensity Music in Adolescents With Anxiety

NCT07492472 | Recruiting

• 1 other identifier: 81725005-13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In modern society, increasing attention has been devoted to mental health problems among adolescents, with anxiety and depressive disorders being particularly prevalent in this population. Evidence indicates that anxiety not only affects emotional states and daily quality of life but also has significant impacts on physiological health, including blood pressure and heart rate. At present, clinical treatment relies primarily on pharmacological interventions and cognitive behavioral therapy; however, these approaches are associated with limitations such as pronounced side effects and delayed onset of efficacy, which restrict their applicability in adolescents. Music and other structured sounds have been used since ancient times to alleviate negative emotional states such as tension and anxiety. Research has shown that listening to soothing music can reduce sympathetic nervous system activity while enhancing parasympathetic tone, thereby leading to a decrease in heart rate and an increase in heart rate variability (HRV). Owing to its gentle characteristics, low-intensity soothing music is considered effective in relieving stress, regulating emotional states, and exerting beneficial effects on physiological indicators.

Conditions

Anxiety

Keywords

Music Therapy

Outcome Measures

Primary Outcomes (2)

• Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) after the intervention.

  The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety.

  Baseline and immediately after the intervention (Day 1)

• Change baseline in anxiety symptoms assessed by the State - Trait Anxiety Inventory (STAI-T; range: 20-80) after the intervention.

  Baseline and immediately after the intervention (Day 1)

Secondary Outcomes (3)

• Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) after the intervention.

  Baseline and immediately after the intervention (Day 1)

• Change from baseline in the cerebral blood volume (CBV) measured by functional near-infrared spectroscopy(fNIRS) after the intervention.

  During the intervention (Day 1)

• Change from baseline in the heart rate variability (HRV) measured by wearable device after the intervention.

  Baseline and immediately after the intervention (Day 1)

Other Outcomes (1)

• Change from baseline in perceived stress assessed by the Momentary assessment of emotional valence and arousal (range: 1-9) after the intervention.

  Baseline and immediately after the intervention (Day 1)

Study Arms (2)

Music Stimulation Group

EXPERIMENTAL

Participants in this group will listen to a pre-selected low-intensity music piece (Pachelbel's Canon in D major, Blenders) for approximately 14 minutes in total, with maximum volume 5 dB above ambient sound. Before the intervention, participants will sit quietly for 5 minutes to establish a baseline, complete self-report questionnaires, and undergo fNIRS and ECG measurements. During the intervention, participants remain silent and seated while cerebral hemodynamics (CBV) and heart rate variability (HRV) are continuously recorded. After the intervention, the same assessments and 5-minute resting recordings are repeated. This arm evaluates clinical response, physiological changes, and neuroimaging features associated with the music intervention.

Other: Low-Intensity Soothing Music

Environmental Sound Control Group

EXPERIMENTAL

Participants in this group will listen to recorded environmental sounds, matched to the music group in decibel level, for the same duration (\~14 minutes). Baseline procedures, including 5 minutes of quiet sitting, self-report questionnaires, fNIRS, and ECG measurements, are identical to the music group. During the intervention, participants remain silent and seated while cerebral hemodynamics (CBV) and heart rate variability (HRV) are continuously recorded. After the intervention, the same assessments and 5-minute resting recordings are repeated.

Behavioral: Environmental Sound Exposure

Interventions

Low-Intensity Soothing Music OTHER

Participants will listen to pre-selected low-intensity soothing music under standardized experimental conditions. Anxiety symptoms, and depressive symptoms will be assessed before and after the intervention. In parallel, heart rate variability (HRV) and fNIRS will be recorded to evaluate the short-term clinical effects of the music intervention and to explore its potential neurophysiological mechanisms.

Music Stimulation Group

Environmental Sound Exposure BEHAVIORAL

Participants listen to recorded environmental sounds matched in decibel to the music group, for \~15 minutes. Baseline and post-intervention assessments are identical to the music group, including self-report questionnaires, fNIRS, and ECG recordings.

Environmental Sound Control Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

Hainan Medical University

Haikou, Hainan, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Fei Wang

  Nanjing Brain Hospital

  STUDY CHAIR

Central Study Contacts

Yue Zhu, Phd

CONTACT

86-18640197059; zhuyuemiiu@163.com

Wang

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: March 25, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-12

Locations

CN (1)