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Integrative Use of Sound Therapy for Mental Health Promotion

1 de maio de 2026 atualizado 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.

Visão geral do estudo

Status

Inscrevendo-se por convite

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

110

Estágio

Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Brasil
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brasil, 30130-100
    - Federal University of Minas Gerais

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Tratamento
Alocação: Randomizado
Modelo Intervencional: Atribuição Paralela
Mascaramento: Nenhum (rótulo aberto)

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
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.	Procedimento: 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.
Comparador Ativo: 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.	Procedimento: 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.

Grupo de Participantes / Braço

Intervenção / Tratamento

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.

Procedimento: 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.

Comparador Ativo: 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.

Procedimento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Change from Baseline in Depression, Anxiety, and Stress Scores Prazo: 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.	Baseline, Day 7 post-intervention, Day 30 post-intervention, and Day 120 post-intervention.

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Change from Baseline in Quality of Life Prazo: Baseline, Day 30 post-intervention, and Day 120 post-intervention.	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 Prazo: aseline, Day 30 post-intervention, and Day 120 post-intervention.	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 Prazo: Baseline, Day 30 post-intervention, and Day 120 post-intervention.	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 Prazo: Baseline, Day 30 post-intervention, and Day 120 post-intervention.	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 Prazo: Baseline, Day 30 post-intervention, and Day 120 post-intervention.	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 Prazo: Baseline, Day 30 post-intervention, and Day 120 post-intervention.	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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Federal University of Minas Gerais

Investigadores

Cadeira de estudo: Laylla CS Gendiroba, MSc, Federal University of Minas Gerais
Cadeira de estudo: UBIRATAN B Castro, MD, PhD, Federal University of Minas Gerais
Cadeira de estudo: Martinho M Sousa Filho, MD, MSc, Federal University of Minas Gerais
Investigador principal: Rubens L C Tavares, MD, PhD, Federal Universtiy of Minas Gerais

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de novembro de 2025

Conclusão Primária (Estimado)

31 de agosto de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

14 de março de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de abril de 2026

Primeira postagem (Real)

1 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

CAAE 84185724.2.0000.5149

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Tipo de informação de suporte de compartilhamento de IPD

PROTOCOLO DE ESTUDO
SEIVA
CIF
ANALYTIC_CODE
CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Integrative Use of Sound Therapy for Mental Health Promotion