Integrative Use of Sound Therapy for Mental Health Promotion

NCT07561515 | Enrolling By Invitation DMC

• 1 other identifier: CAAE 84185724.2.0000.5149
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Insonia; Sound Therapy; Music Therapy; Mental Health; Stress; Depression; Quality of Life; Acoustic Resonance; Anxiety

Keywords

Anxiety; Stress, Psychological; Depression; Mental Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from Baseline in Quality of Life

  Baseline, Day 30 post-intervention, and Day 120 post-intervention.

• Change from Baseline in Insomnia Severity

  aseline, Day 30 post-intervention, and Day 120 post-intervention.

• Change from Baseline in Human Flourishing

  Baseline, Day 30 post-intervention, and Day 120 post-intervention.

• Change from Baseline in Religiosity

  Baseline, Day 30 post-intervention, and Day 120 post-intervention.

• Change from Baseline in General Health

  Baseline, Day 30 post-intervention, and Day 120 post-intervention.

Study Arms (2)

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.

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.

Procedure: Control Group with Headphones

Interventions

Acoustic Resonance Sound Therapy PROCEDURE

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.

Acoustic Resonance Chamber

Control Group with Headphones PROCEDURE

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.

Control Group with Headphones

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Related Publications (5)

• 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.

  PMID: 24238871 BACKGROUND

• 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.

  PMID: 28705870 BACKGROUND

• 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.

  PMID: 21107911 BACKGROUND

• 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.

  PMID: 10881154 BACKGROUND

• 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.

  PMID: 32401941 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Anxiety Disorders; Depression; Stress, Psychological

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• 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

  STUDY CHAIR

• Rubens L C Tavares, MD, PhD

  Federal Universtiy of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: May 1, 2026
• Study Start: November 2, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BR (1)