Integrative Use of Sound Therapy for Mental Health Promotion: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change from Baseline in Depression, Anxiety, and Stress Scores
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Acoustic Resonance Sound Therapy (Procedure)
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.
干预措施: Control Group with Headphones (Procedure)
结局指标
主要结局
Change from Baseline in Depression, Anxiety, and Stress Scores
时间窗: 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.
次要结局
- Change from Baseline in Quality of Life(Baseline, Day 30 post-intervention, and Day 120 post-intervention.)
- Change from Baseline in Insomnia Severity(aseline, Day 30 post-intervention, and Day 120 post-intervention.)
- Change from Baseline in Human Flourishing(Baseline, Day 30 post-intervention, and Day 120 post-intervention.)
- Change from Baseline in Religiosity(Baseline, Day 30 post-intervention, and Day 120 post-intervention.)
- Change from Baseline in General Health(Baseline, Day 30 post-intervention, and Day 120 post-intervention.)
- Change from Baseline in Alcohol Use(Baseline, Day 30 post-intervention, and Day 120 post-intervention.)
研究者
Rubens Lene Carvalho Tavares
Associate Professor
Federal University of Minas Gerais