Sound TherapyNCT07561515
Integrative Use of Sound Therapy for Mental Health Promotion
A study testing Acoustic Resonance Sound Therapy in people with Sound Therapy and Music Therapy, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
This randomized clinical trial aims to evaluate the effectiveness of sound therapy in improving mental health and quality of life. Participants will be randomized into two groups: an intervention group using an acoustic resonance chamber and a control group using headphones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sound Therapy, Music Therapy, Mental Health
- What is being tested?
- Acoustic Resonance Sound Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria
- Age over 18 years
- DASS-21 score consistent with at least mild anxiety, stress, or depression
- Agreement to complete the 3-week protocol and follow-up questionnaires
- Agreement not to practice other mind-body therapies during the study
- Maintenance of conventional medical and/or psychological treatments
- Exclusion Criteria
- Normal scores on the DASS-21
- Presence of severe neurological, psychiatric, or clinical disorders
- Use of high doses of medication that prevent standing for 9 minutes
- Use of metal plates or devices in the body
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
About this study
Official title: Integrative Use of Sound Therapy for Mental Health Promotion: A Randomized Clinical Trial
This randomized clinical trial aims to evaluate the effectiveness of sound therapy in improving mental health and quality of life. Participants will be randomized into two groups: an intervention group using an acoustic resonance chamber and a control group using headphones. Both groups will be exposed to specific sound frequencies for nine minutes, once a week, for three weeks. The study investigates associations between sound therapy and levels of anxiety, stress, depression, and quality of life.
Read the detailed description
- Mental health disorders such as anxiety, stress, and depression are prevalent global health issues. Sound therapy is proposed as an integrative complementary therapy to address these conditions. This prospective randomized open-label study involves 110 participants.
- Participants will be randomized into:
> 1. *Intervention Group:* Receives sound therapy inside a specifically designed acoustic resonance chamber.
> 2. *Control Group:* Receives the same sound therapy sequence using headphones, without the chamber.
- The intervention consists of three weekly sessions of 9 minutes each. The sound protocol uses nine specific frequencies (ranging from 174 Hz to 936 Hz) derived from a 432 Hz tuning reference. Outcomes will be measured using validated scales including DASS-21, WHOQOL-Bref, and others at baseline, during the intervention, and at 30-day and 120-day follow-ups.
- Conditions
- Sound Therapy, Music Therapy, Mental Health, Anxiety, Stress, Depression
- Being tested
- Acoustic Resonance Sound Therapy, Control Group with Headphones
- Keywords
- Anxiety, Stress, Psychological, Depression, Mental Health
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders, Depression, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic Resonance Sound TherapyProcedure or surgery
Participants will receive sound therapy in 3 sessions, one session per week, each lasting 9 minutes. The protocol uses 9 sound frequencies as follows: session 1 will use the frequencies of 396 Hz (close to the note G), 639 Hz (close to the note E), and 963 Hz (close to the note B); session 2 will use the frequencies of 174 Hz (close to the note F), 417 Hz (close to the note G sharp), and 741 Hz (close to the note F sharp); and session 3 will use the frequencies of 285 Hz (close to the note D), 528 Hz (close to the note C), and 852 Hz (close to the note A), with each frequency applied for three minutes. Sound therapy is performed inside an acoustic resonance chamber, designed to optimize sound pressure distribution.
Control Group with HeadphonesProcedure or surgery
Participants will receive sound therapy in 3 sessions, one session per week, each lasting 9 minutes. The protocol uses 9 sound frequencies as follows: session 1 will use the frequencies of 396 Hz (close to the note G), 639 Hz (close to the note E), and 963 Hz (close to the note B); session 2 will use the frequencies of 174 Hz (close to the note F), 417 Hz (close to the note G sharp), and 741 Hz (close to the note F sharp); and session 3 will use the frequencies of 285 Hz (close to the note D), 528 Hz (close to the note C), and 852 Hz (close to the note A), with each frequency applied for three minutes. Participants receive the sound protocol through headphones, while remaining seated.
| Study group | Role | What they receive |
|---|---|---|
| Acoustic Resonance Chamber | Experimental | Participants listen to specific sound frequencies inside a cylindrical acoustic resonance chamber (190 cm high and 90 cm in diameter), designed to optimize sound pressure distribution. Sessions last 9 minutes, once a week, for 3 weeks. Receives: Procedure: Acoustic Resonance Sound Therapy |
| Control Group with Headphones | Active comparator | Participants listen to exactly the same sound frequencies, for the same duration (9 minutes, once a week, for 3 weeks), using headphones while remaining seated in a chair, outside the acoustic chamber environment. Receives: Procedure: Control Group with Headphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Depression, Anxiety, and Stress Scores
Assessed using the 21-item Depression, Anxiety, and Stress Scale (DASS-21). It assesses the severity of the core symptoms of depression, anxiety, and stress. It consists of three subscales. The total score for each subscale is calculated by summing the scores of the 7 relevant items (scored from 0 to 3) and multiplying by 2. Therefore, final scores for each subscale range from 0 to 42. Higher scores indicate greater symptom severity.
Measured: Baseline, Day 7 post-intervention, Day 30 post-intervention, and Day 120 post-intervention.
Secondary outcomes (6)
Change from Baseline in Quality of Life
Assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF). The total scores for the domains are transformed to a scale ranging from 0 to 100. Higher scores indicate a better quality of life.
Measured: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
Change from Baseline in Insomnia Severity
Assessed using the Insomnia Severity Index (ISI). Total scores range from 0 to 28. Higher scores indicate more severe insomnia.
Measured: aseline, Day 30 post-intervention, and Day 120 post-intervention.
Change from Baseline in Human Flourishing
Assessed using the Harvard Human Flourishing Program measure. The instrument consists of 12 items scored on a scale of 0 to 10. The total score (Secure Flourish Index) ranges from 0 to 120. Higher scores indicate a higher level of psychosocial prosperity and flourishing.
Measured: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
Change from Baseline in Religiosity
Assessed using the Duke University Religion Index (DUREL). The total score ranges from 5 to 27. Higher scores indicate greater religious involvement and religiosity.
Measured: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
Change from Baseline in General Health
ssessed using the 12-item General Health Questionnaire (GHQ-12). It evaluates psychological distress and current mental health. Scores are scaled from 0 to 36 (using the 0-1-2-3 Likert scoring method). Higher scores indicate worse psychological well-being and higher levels of distress.
Measured: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
Change from Baseline in Alcohol Use
Assessed using the Alcohol Use Disorders Identification Test (AUDIT). This 10-item screening tool measures alcohol consumption, drinking behaviors, and alcohol-related problems. Total scores range from 0 to 40. Higher scores indicate more hazardous and harmful alcohol use.
Measured: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start2 Nov 2025
- Primary completion31 Aug 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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sound TherapyStudies 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
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubens Lene Carvalho Tavares, Federal University of Minas Gerais
- Investigators
- Laylla CS Gendiroba, MSc, Study chair, Federal University of Minas GeraisUBIRATAN B Castro, MD, PhD, Study chair, Federal University of Minas GeraisMartinho M Sousa Filho, MD, MSc, Study chair, Federal University of Minas GeraisRubens L C Tavares, MD, PhD, Principal investigator, Federal Universtiy of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561515
- Sponsor's protocol ID
- CAAE 84185724.2.0000.5149
- Status last verified
- May 2026
- First submitted
- 14 Mar 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Vignola RC, Tucci AM. Adaptation and validation of the depression, anxiety and stress scale (DASS) to Brazilian Portuguese. J Affect Disord. 2014 Feb;155:104-9. doi: 10.1016/j.jad.2013.10.031. Epub 2013 Oct 28.
PubMed 24238871VanderWeele TJ. On the promotion of human flourishing. Proc Natl Acad Sci U S A. 2017 Aug 1;114(31):8148-8156. doi: 10.1073/pnas.1702996114. Epub 2017 Jul 13.
PubMed 28705870Lucchetti G, Granero Lucchetti AL, Peres MF, Leao FC, Moreira-Almeida A, Koenig HG. Validation of the Duke Religion Index: DUREL (Portuguese version). J Relig Health. 2012 Jun;51(2):579-86. doi: 10.1007/s10943-010-9429-5.
PubMed 21107911Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
PubMed 10881154Aravena PC, Almonacid C, Mancilla MI. Effect of music at 432 Hz and 440 Hz on dental anxiety and salivary cortisol levels in patients undergoing tooth extraction: a randomized clinical trial. J Appl Oral Sci. 2020;28:e20190601. doi: 10.1590/1678-7757-2019-0601. Epub 2020 May 11.
PubMed 32401941
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Use of Sound Therapy for Mental Health Promotion: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07561515
- Acronym / sponsor ID
- CAAE 84185724.2.0000.5149
- Conditions
- Sound Therapy, Music Therapy, Mental Health, Anxiety, Stress, Depression
- Keywords
- Anxiety, Stress, Psychological, Depression, Mental Health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 2 Nov 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 May 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.
This randomized clinical trial aims to evaluate the effectiveness of sound therapy in improving mental health and quality of life. Participants will be randomized into two groups: an intervention group using an acoustic resonance chamber and a control group using headphones. Both groups will be exposed to specific sound frequencies for nine minutes, once a week, for three weeks. The study investigates associations between sound therapy and levels of anxiety, stress, depression, and quality of life.
Detailed description
- Mental health disorders such as anxiety, stress, and depression are prevalent global health issues. Sound therapy is proposed as an integrative complementary therapy to address these conditions. This prospective randomized open-label study involves 110 participants.
- Participants will be randomized into:
> 1. *Intervention Group:* Receives sound therapy inside a specifically designed acoustic resonance chamber.
> 2. *Control Group:* Receives the same sound therapy sequence using headphones, without the chamber.
- The intervention consists of three weekly sessions of 9 minutes each. The sound protocol uses nine specific frequencies (ranging from 174 Hz to 936 Hz) derived from a 432 Hz tuning reference. Outcomes will be measured using validated scales including DASS-21, WHOQOL-Bref, and others at baseline, during the intervention, and at 30-day and 120-day follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acoustic Resonance Chamber | Experimental | Procedure: Acoustic Resonance Sound TherapyParticipants listen to specific sound frequencies inside a cylindrical acoustic resonance chamber (190 cm high and 90 cm in diameter), designed to optimize sound pressure distribution. Sessions last 9 minutes, once a week, for 3 weeks. |
| Control Group with Headphones | Active comparator | Procedure: Control Group with HeadphonesParticipants listen to exactly the same sound frequencies, for the same duration (9 minutes, once a week, for 3 weeks), using headphones while remaining seated in a chair, outside the acoustic chamber environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Acoustic Resonance Sound TherapyParticipants will receive sound therapy in 3 sessions, one session per week, each lasting 9 minutes. The protocol uses 9 sound frequencies as follows: session 1 will use the frequencies of 396 Hz (close to the note G), 639 Hz (close to the note E), and 963 Hz (close to the note B); session 2 will use the frequencies of 174 Hz (close to the note F), 417 Hz (close to the note G sharp), and 741 Hz (close to the note F sharp); and session 3 will use the frequencies of 285 Hz (close to the note D), 528 Hz (close to the note C), and 852 Hz (close to the note A), with each frequency applied for three minutes. Sound therapy is performed inside an acoustic resonance chamber, designed to optimize sound pressure distribution. | Procedure or surgery | Acoustic Resonance Chamber |
| Control Group with HeadphonesParticipants will receive sound therapy in 3 sessions, one session per week, each lasting 9 minutes. The protocol uses 9 sound frequencies as follows: session 1 will use the frequencies of 396 Hz (close to the note G), 639 Hz (close to the note E), and 963 Hz (close to the note B); session 2 will use the frequencies of 174 Hz (close to the note F), 417 Hz (close to the note G sharp), and 741 Hz (close to the note F sharp); and session 3 will use the frequencies of 285 Hz (close to the note D), 528 Hz (close to the note C), and 852 Hz (close to the note A), with each frequency applied for three minutes. Participants receive the sound protocol through headphones, while remaining seated. | Procedure or surgery | Control Group with Headphones |
Primary outcome
Change from Baseline in Depression, Anxiety, and Stress Scores
Time frame: Baseline, Day 7 post-intervention, Day 30 post-intervention, and Day 120 post-intervention.
Assessed using the 21-item Depression, Anxiety, and Stress Scale (DASS-21). It assesses the severity of the core symptoms of depression, anxiety, and stress. It consists of three subscales. The total score for each subscale is calculated by summing the scores of the 7 relevant items (scored from 0 to 3) and multiplying by 2. Therefore, final scores for each subscale range from 0 to 42. Higher scores indicate greater symptom severity.
6 secondary outcomes
Change from Baseline in Quality of Life
Time frame: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
Change from Baseline in Insomnia Severity
Time frame: aseline, Day 30 post-intervention, and Day 120 post-intervention.
Change from Baseline in Human Flourishing
Time frame: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
Change from Baseline in Religiosity
Time frame: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
Change from Baseline in General Health
Time frame: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
Change from Baseline in Alcohol Use
Time frame: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
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 7 May 2026.
- Background: PubMed 24238871Vignola RC, Tucci AM. Adaptation and validation of the depression, anxiety and stress scale (DASS) to Brazilian Portuguese. J Affect Disord. 2014 Feb;155:104-9. doi: 10.1016/j.jad.2013.10.031. Epub 2013 Oct 28.
- Background: PubMed 28705870VanderWeele TJ. On the promotion of human flourishing. Proc Natl Acad Sci U S A. 2017 Aug 1;114(31):8148-8156. doi: 10.1073/pnas.1702996114. Epub 2017 Jul 13.
- Background: PubMed 21107911Lucchetti G, Granero Lucchetti AL, Peres MF, Leao FC, Moreira-Almeida A, Koenig HG. Validation of the Duke Religion Index: DUREL (Portuguese version). J Relig Health. 2012 Jun;51(2):579-86. doi: 10.1007/s10943-010-9429-5.
- Background: PubMed 10881154Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
- Background: PubMed 32401941Aravena PC, Almonacid C, Mancilla MI. Effect of music at 432 Hz and 440 Hz on dental anxiety and salivary cortisol levels in patients undergoing tooth extraction: a randomized clinical trial. J Appl Oral Sci. 2020;28:e20190601. doi: 10.1590/1678-7757-2019-0601. Epub 2020 May 11.
- Individual participant dataSharing planned: Yes
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.
Laylla CS Gendiroba, MSc study chair
Federal University of Minas Gerais
UBIRATAN B Castro, MD, PhD study chair
Federal University of Minas Gerais
Martinho M Sousa Filho, MD, MSc study chair
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic Resonance Sound Therapy in people with Sound Therapy and Music Therapy, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: enrolling by invitation, as of the sponsor's last update on 7 May 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 Brazil. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Depression, Anxiety, and Stress Scores (time frame: Baseline, Day 7 post-intervention, Day 30 post-intervention, and Day 120 post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07561515, which also lists 5 linked publications.
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 7 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.