Integrative Use of Sound Therapy for Mental Health Promotion

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Depression; Quality of Life; Stress; Anxiety; Mental Health; Music Therapy; Sound Therapy; Acoustic Resonance; Insonia
• Intervention / Treatment: Procedure: Acoustic Resonance Sound Therapy; Procedure: Control Group with Headphones

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Federal University of Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

1. 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

2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acoustic Resonance Chamber; 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.	Procedure: Acoustic Resonance Sound Therapy; 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.
Active Comparator: Control Group with Headphones; 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.	Procedure: Control Group with Headphones; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Day 7 post-intervention, Day 30 post-intervention, and Day 120 post-intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Baseline, Day 30 post-intervention, and Day 120 post-intervention.

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Study Chair: Laylla CS Gendiroba, MSc, Federal University of Minas Gerais; Study Chair: UBIRATAN B Castro, MD, PhD, Federal University of Minas Gerais; Study Chair: Martinho M Sousa Filho, MD, MSc, Federal University of Minas Gerais; Principal Investigator: Rubens L C Tavares, MD, PhD, Federal Universtiy of Minas Gerais

Publications and helpful links

General Publications

• Fleck 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.
• Aravena 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.
• VanderWeele 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.
• 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.
• Lucchetti 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 14, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Mental Health; Anxiety; Stress, Psychological
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Anxiety Disorders; Depression; Stress, Psychological; Psychological Well-Being; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: CAAE 84185724.2.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No