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.
調査の概要
状態
招待による登録
詳細な説明
- 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.
研究の種類
介入
入学 (推定)
110
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Minas Gerais
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Belo Horizonte、Minas Gerais、ブラジル、30130-100
- Federal University of Minas Gerais
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in Depression, Anxiety, and Stress Scores
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in Quality of Life
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Laylla CS Gendiroba, MSc、Federal University of Minas Gerais
- スタディチェア：UBIRATAN B Castro, MD, PhD、Federal University of Minas Gerais
- スタディチェア：Martinho M Sousa Filho, MD, MSc、Federal University of Minas Gerais
- 主任研究者：Rubens L C Tavares, MD, PhD、Federal Universtiy of Minas Gerais
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年11月2日
一次修了 (推定)
2026年8月31日
研究の完了 (推定)
2026年12月31日
試験登録日
最初に提出
2026年3月14日
QC基準を満たした最初の提出物
2026年4月24日
最初の投稿 (実際)
2026年5月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月7日
QC基準を満たした最後の更新が送信されました
2026年5月1日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- CAAE 84185724.2.0000.5149
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