Sound Healing for Anxiety: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Anxiety
研究概览
简要总结
The goal of this randomized controlled trial is to compare a novel sound healing approach, biofield tuning, to a waitlist control group in a healthy adult population naive to the intervention. The main questions it aims to answer are:
- Is there a significant reduction in state and trait anxiety as measured by the State-Trait Anxiety Index (STAI) with biofield tuning compared to waitlist control?
- Are there significant reductions in negative affect, as well as increases in self-compassion, positive affect, and interoceptive awareness in the intervention group?
- What are the relationships between changes in anxiety symptoms, negative affect words, and microbiome changes in participants who have undergone this biofield intervention?
Participants will be:
- Randomized to intervention/control
- Recieve 5 sound healing interventions weekly
- Asked to complete surveys and audio prompts throughout the intervention
- Asked to provide a microbiome sample pre- and post-intervention
详细描述
There is an increasing rate of anxiety among the US population, without adequate amounts of resources for treatment. Current pharmacological and psychological treatments for generalized anxiety disorder delivered by doctors, nurses, and clinical psychologists are often expensive and not freely available for many who need effective interventions for anxiety. A novel sound healing approach, Biofield Tuning (BT), has suggested potential benefits to those suffering from generalized anxiety. This intervention, while requiring training and certification, allows for holistic health practitioners to treat anxiety as a complementary mind-body therapy for those seeking relief for anxiety.
Intervention. BT is a non-invasive, non-medical therapeutic practice developed by Eileen Day McKusick. BT Practitioners use a tuning fork to identify off-the-body sites at which perturbations in the tuning fork sound are detected. Such sites are described by BT practitioners as storing health-related information within the human biofield. Practitioners describe the process of BT as assessing and clearing perturbations in the human biofield to foster healing.
Previous Feasibility Study. Our initial cohort study showed that conducting research for this novel sound healing approach online was feasible and suggested clinical benefits for people struggling with moderate to severe generalized anxiety, as noted in our peer-reviewed scientific publication. This RCT is designed to build upon the previous cohort study by comparing this intervention with a control group to further determine the effectiveness of BT compared to treatment as usual.
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
- Single (Outcomes Assessor)
盲法说明
Once randomized, the participants will know they are receiving the intervention. Outcomes assessor will be masked for data analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 18 years or older (≥ 18)
- •Biofield-tuning naive (have never had a session of biofield tuning before)
- •Speak and understand English at a native level
- •Have a score ≥10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
- •Have regular access to a computer
- •Have experience using a computer
- •Be comfortable using Zoom and completing data collection activities online and over the phone
排除标准
- •Suffering from any severe psychological, physical, or cognitive disease or impairment.
- •An active diagnosis or history of suicidality, Post-Traumatic Stress Disorder (PTSD), schizophrenia, or psychotic disorders. This includes history or current suicidality, suicide ideation, and intent to harm self or others.
- •Women who are pregnant or nursing.
- •Having an electronically implanted device, excluding cochlear implants.
- •Currently seeking treatment for an active cancer.
- •Currently has an untreated serious illness (e.g. heart disease, diabetes, etc.).
结局指标
主要结局
Anxiety
时间窗: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks
The main objective is to assess whether virtually-delivered biofield tuning can significantly reduce moderate to high levels of generalized anxiety as measured by the State Trait Anxiety Index (STAI).
次要结局
- mental health recovery(Baseline, at 3 weeks, 5 weeks and 1-month post-intervention)
- self compassion(Baseline, at 3 weeks, 5 weeks and 1-month post-intervention)
- perceived social support(Baseline, at 3 weeks, 5 weeks and 1-month post-intervention)
- depressive symptoms(Baseline, at 3 weeks, 5 weeks and 1-month post-intervention)
- Anxiety 1-month(1-month post-intervention)
- Interoceptive awareness(Baseline, at 5 weeks)
- stress(Baseline, at 3 weeks, 5 weeks and 1-month post-intervention)
- relationship with practitioner(at 1 week, 3 weeks, and 5 weeks)
- Positive and Negative Affect(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention)