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Integrative Use of Sound Therapy for Mental Health Promotion

1. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

  • 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.

Studietype

Intervensjonell

Registrering (Antatt)

110

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

  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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: 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.
Aktiv komparator: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in Depression, Anxiety, and Stress Scores
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in Quality of Life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Federal University of Minas Gerais

Etterforskere

  • Studiestol: Laylla CS Gendiroba, MSc, Federal University of Minas Gerais
  • Studiestol: UBIRATAN B Castro, MD, PhD, Federal University of Minas Gerais
  • Studiestol: Martinho M Sousa Filho, MD, MSc, Federal University of Minas Gerais
  • Hovedetterforsker: Rubens L C Tavares, MD, PhD, Federal Universtiy of Minas Gerais

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. november 2025

Primær fullføring (Antatt)

31. august 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

14. mars 2026

Først innsendt som oppfylte QC-kriteriene

24. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CAAE 84185724.2.0000.5149

Plan for individuelle deltakerdata (IPD)

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JA

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

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