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Integrative Use of Sound Therapy for Mental Health Promotion

1 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

110

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: 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.	Procedura: 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.
Comparatore attivo: 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.	Procedura: 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.

Gruppo di partecipanti / Arm

Intervento / Trattamento

Sperimentale: 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.

Procedura: 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.

Comparatore attivo: 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.

Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change from Baseline in Depression, Anxiety, and Stress Scores Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change from Baseline in Quality of Life Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Federal University of Minas Gerais

Investigatori

Cattedra di studio: Laylla CS Gendiroba, MSc, Federal University of Minas Gerais
Cattedra di studio: UBIRATAN B Castro, MD, PhD, Federal University of Minas Gerais
Cattedra di studio: Martinho M Sousa Filho, MD, MSc, Federal University of Minas Gerais
Investigatore principale: Rubens L C Tavares, MD, PhD, Federal Universtiy of Minas Gerais

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 novembre 2025

Completamento primario (Stimato)

31 agosto 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

14 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

CAAE 84185724.2.0000.5149

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STUDIO_PROTOCOLLO
LINFA
ICF
CODICE_ANALITICO
RSI

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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Acoustic Resonance Sound Therapy

King's College London

Non ancora reclutamento

Studio di accettabilità delle origini del suono (Soundorigins)

Accessibilità e accettabilità dell'intervento

Regno Unito

Integrative Use of Sound Therapy for Mental Health Promotion