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NCT Number: NCT07561515

Integrative Use of Sound Therapy for Mental Health Promotion

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.

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Key information

Conditions

Sound Therapy Acoustic Resonance Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Insonia Mental Disorders Mental Health Music Therapy Personal Satisfaction Psychological Well-Being Quality of Life Stress Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from Baseline in Depression, Anxiety, and Stress Scores

    Time frame: 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.

Secondary outcomes

  1. Change from Baseline in Quality of Life

    Time frame: 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.

  2. Change from Baseline in Insomnia Severity

    Time frame: 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.

  3. Change from Baseline in Human Flourishing

    Time frame: 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.

  4. Change from Baseline in Religiosity

    Time frame: 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.

  5. Change from Baseline in General Health

    Time frame: 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.

  6. Change from Baseline in Alcohol Use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Integrative Use of Sound Therapy for Mental Health Promotion: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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