AnxietyNCT07492472
The Effects of Low-Intensity Music in Adolescents With Anxiety
A study testing Low-Intensity Soothing Music and Environmental Sound Exposure in people with Anxiety, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Low-Intensity Soothing Music and Environmental Sound Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wang contact
China1 site, 1 recruiting
- Recruiting
Hainan Medical University
Haikou, Hainan
Lijuan Liang, Phd, 86-18640197059, lianglijuan_2005@163.com
About this study
Official title: The Effects of Low-Intensity Music on Brain-Heart Function in Adolescents With Anxiety
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.
Read the detailed description
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.
- Conditions
- Anxiety
- Being tested
- Low-Intensity Soothing Music, Environmental Sound Exposure
- Keywords
- Music Therapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Soothing MusicOther
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.
Environmental Sound ExposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Environmental Sound Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-27) depression.
Measured: 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.
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.
Measured: During the intervention (Day 1)
Change from baseline in the heart rate variability (HRV) measured by wearable device after the intervention.
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.
Measured: Baseline and immediately after the intervention (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start15 Dec 2025
- Primary completion30 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Wang, Study chair, Nanjing Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492472
- Sponsor's protocol ID
- 81725005-13
- Status last verified
- Dec 2025
- First submitted
- 4 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low-Intensity Music on Brain-Heart Function in Adolescents With Anxiety
- ClinicalTrials.gov ID
- NCT07492472
- Acronym / sponsor ID
- 81725005-13
- Conditions
- Anxiety
- Keywords
- Music Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Province Nanjing Brain HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Stimulation Group | Experimental | Other: Low-Intensity Soothing MusicParticipants 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. |
| Environmental Sound Control Group | Experimental | Behavioral: Environmental Sound ExposureParticipants 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Soothing MusicParticipants 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. | Other | Music Stimulation Group |
| Environmental Sound ExposureParticipants 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. | Behavioural | Environmental Sound Control Group |
Primary outcome
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) after the intervention.
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.
Change baseline in anxiety symptoms assessed by the State - Trait Anxiety Inventory (STAI-T; range: 20-80) after the intervention.
Time frame: Baseline and immediately after the intervention (Day 1)
3 secondary outcomes
Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) after the intervention.
Time frame: 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.
Time frame: During the intervention (Day 1)
Change from baseline in the heart rate variability (HRV) measured by wearable device after the intervention.
Time frame: Baseline and immediately after the intervention (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wang contact
Fei Wang study chair
Nanjing Brain Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Soothing Music and Environmental Sound Exposure in people with Anxiety, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Zhu, Phd (86-18640197059, zhuyuemiiu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) after the intervention. (time frame: Baseline and immediately after the intervention (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.