Hainan Medical University
Haikou, Hainan, China
Location status: Recruiting
NCT Number: NCT07492472
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.
Interested in participating?
Request Info18 year–25 year
All sexes
Interventional
Not applicable
Haikou, Hainan, China
Location status: Recruiting
In modern society, adolescent mental health problems have attracted increasing attention. Anxiety disorders, as one of the most representative manifestations, not only impair daily functioning and academic performance but may also exert profound effects on physiological health. In recent years, music therapy, as a non-pharmacological intervention, has demonstrated considerable potential in alleviating anxiety. The present study aims to investigate the effects of low-intensity soothing music on physiological indicators, including cerebral blood flow and heart rate, in adolescents experiencing anxiety episodes, using functional near-infrared spectroscopy (fNIRS). This research not only contributes to a deeper understanding of the mechanisms underlying music therapy but also provides a scientific basis for the development of more effective interventions for adolescent anxiety.
Using fNIRS, we will continuously monitor changes in cortical cerebral blood flow, as alterations in hemodynamic patterns can directly reflect the effects of music-based interventions. Heart rate, as another key physiological indicator, will be continuously recorded and analyzed throughout the experiment. By means of a wearable smart band, we will capture heart rate variability (HRV) as well as temporal trends in heart rate. These data will enable us to determine whether low-intensity soothing music can reduce heart rate levels and enhance autonomic nervous system balance in adolescents with anxiety. In addition, immediate changes in heart rate before and after music exposure will be evaluated to assess the short-term effects of the intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline and immediately after the intervention (Day 1)
The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety.
Time frame: Baseline and immediately after the intervention (Day 1)
Time frame: Baseline and immediately after the intervention (Day 1)
The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-27) depression.
Time frame: During the intervention (Day 1)
Participants will undergo fNIRS scans prior to beginning music treatment (baseline) and after completing music treatment (after the intervention). CBV is a fNIRS indicator that reflects the alterations in cerebral blood flow.
Time frame: Baseline and immediately after the intervention (Day 1)
Participants will undergo wearable device prior to beginning music treatment (baseline) and after completing music treatment (after the intervention). HRV is a heart indicator that reflects the alterations in autonomic nervous system.
Time frame: Baseline and immediately after the intervention (Day 1)
Effects of the intervention on emotional valence (positive/negative) and arousal.
Contact information is provided by the study sponsor or research team.
Jiangsu Province Nanjing Brain Hospital
Other
The Effects of Low-Intensity Music on Brain-Heart Function in Adolescents With Anxiety
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