Integrative Use of Sound Therapy for Mental Health Promotion
2026年5月1日 更新者：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.
研究概览
地位
邀请报名
详细说明
- 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.
研究类型
介入性
注册 (估计的)
110
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Minas Gerais
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Belo Horizonte、Minas Gerais、巴西、30130-100
- Federal University of Minas Gerais
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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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有源比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change from Baseline in Depression, Anxiety, and Stress Scores
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change from Baseline in Quality of Life
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Laylla CS Gendiroba, MSc、Federal University of Minas Gerais
- 学习椅：UBIRATAN B Castro, MD, PhD、Federal University of Minas Gerais
- 学习椅：Martinho M Sousa Filho, MD, MSc、Federal University of Minas Gerais
- 首席研究员：Rubens L C Tavares, MD, PhD、Federal Universtiy of Minas Gerais
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年11月2日
初级完成 (估计的)
2026年8月31日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2026年3月14日
首先提交符合 QC 标准的
2026年4月24日
首次发布 (实际的)
2026年5月1日
研究记录更新
最后更新发布 (实际的)
2026年5月7日
上次提交的符合 QC 标准的更新
2026年5月1日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.