Integrative Use of Sound Therapy for Mental Health Promotion

Official title

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

Overview

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.

Detailed description

* 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.

Interventions

• Procedure 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), 5
• Procedure 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), 5

Primary outcome measures

• 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.]

Secondary outcome measures (6)

• Change from Baseline in Quality of Life [Time frame: Baseline, Day 30 post-intervention, and Day 120 post-intervention.]
• Change from Baseline in Insomnia Severity [Time frame: aseline, Day 30 post-intervention, and Day 120 post-intervention.]
• Change from Baseline in Human Flourishing [Time frame: Baseline, Day 30 post-intervention, and Day 120 post-intervention.]
• Change from Baseline in Religiosity [Time frame: Baseline, Day 30 post-intervention, and Day 120 post-intervention.]
• Change from Baseline in General Health [Time frame: Baseline, Day 30 post-intervention, and Day 120 post-intervention.]
• Change from Baseline in Alcohol Use [Time frame: Baseline, Day 30 post-intervention, and Day 120 post-intervention.]

Eligibility criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Federal University of Minas Gerais — Belo Horizonte

Publications

• 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. PMID 24238871
• 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. PMID 28705870
• 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. PMID 21107911
• 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. PMID 10881154
• 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. PMID 32401941

Identifiers

NCT: NCT07561515 · CAAE 84185724.2.0000.5149

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗