Integrative Use of Sound Therapy for Mental Health Promotion
1 de mayo de 2026 actualizado por: Rubens Lene Carvalho Tavares, Federal University of Minas Gerais
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.
Descripción general del estudio
Estado
Inscripción por invitación
Condiciones
Intervención / Tratamiento
Descripción detallada
- 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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
110
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 30130-100
- Federal University of Minas Gerais
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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.
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Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Depression, Anxiety, and Stress Scores
Periodo de tiempo: Baseline, Day 7 post-intervention, Day 30 post-intervention, and Day 120 post-intervention.
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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.
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Baseline, Day 7 post-intervention, Day 30 post-intervention, and Day 120 post-intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from Baseline in Quality of Life
Periodo de tiempo: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
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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.
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Baseline, Day 30 post-intervention, and Day 120 post-intervention.
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Change from Baseline in Insomnia Severity
Periodo de tiempo: aseline, Day 30 post-intervention, and Day 120 post-intervention.
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Assessed using the Insomnia Severity Index (ISI).
Total scores range from 0 to 28.
Higher scores indicate more severe insomnia.
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aseline, Day 30 post-intervention, and Day 120 post-intervention.
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Change from Baseline in Human Flourishing
Periodo de tiempo: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
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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.
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Baseline, Day 30 post-intervention, and Day 120 post-intervention.
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Change from Baseline in Religiosity
Periodo de tiempo: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
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Assessed using the Duke University Religion Index (DUREL).
The total score ranges from 5 to 27.
Higher scores indicate greater religious involvement and religiosity.
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Baseline, Day 30 post-intervention, and Day 120 post-intervention.
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Change from Baseline in General Health
Periodo de tiempo: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
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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.
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Baseline, Day 30 post-intervention, and Day 120 post-intervention.
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Change from Baseline in Alcohol Use
Periodo de tiempo: Baseline, Day 30 post-intervention, and Day 120 post-intervention.
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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.
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Baseline, Day 30 post-intervention, and Day 120 post-intervention.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Laylla CS Gendiroba, MSc, Federal University of Minas Gerais
- Silla de estudio: UBIRATAN B Castro, MD, PhD, Federal University of Minas Gerais
- Silla de estudio: Martinho M Sousa Filho, MD, MSc, Federal University of Minas Gerais
- Investigador principal: Rubens L C Tavares, MD, PhD, Federal Universtiy of Minas Gerais
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de noviembre de 2025
Finalización primaria (Estimado)
31 de agosto de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
14 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de abril de 2026
Publicado por primera vez (Actual)
1 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CAAE 84185724.2.0000.5149
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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Ensayos clínicos sobre Acoustic Resonance Sound Therapy
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