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临床试验/NCT07281989
NCT07281989招募中不适用

Sound Stops Stress Study: Evaluating the WAVwatch Effect

Efforia, Inc2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Perceived Stress Scale (Past Week Version)

研究概览

简要总结

Sound Off Stress Study seeks to discover if WAVwatch 2.0-a sleek, wearable sound frequency device-can support mental harmony.

详细描述

This remotely administered decentralized trial is designed to rigorously evaluate the efficacy of the WAVwatch 2.0, a cutting-edge sound frequency device, in mitigating stress and everyday anxiety. In an era where stress pervades our daily lives, the need for innovative, science-backed solutions has never been more critical. Amidst the growing social media enthusiasm surrounding sound therapy's tranquil effects, this study seeks to scientifically substantiate the capabilities of WAVwatch 2.0, aiming to either validate or debunk the widespread claims of its beneficial impact on mental states.

The primary objective is to equip participants with precise, data-driven insights regarding the potential of WAVwatch 2.0 to diminish stress and anxiety levels. By partaking in this investigation, individuals will gain a personal understanding of their mental wellness journey, assessing firsthand whether this sophisticated, wearable technology can integrate seamlessly into their lives and foster the tranquility and equilibrium they aspire to achieve.

The core aims and objectives of this trial center around the thorough assessment of WAVwatch 2.0's effectiveness in lowering stress and anxiety, whilst concurrently promoting overall life satisfaction. Through personalized feedback, participants will be endowed with the knowledge necessary to make enlightened decisions regarding their stress management strategies and potential financial commitments to wellness technologies.

The significance and impact of this study are vast, with the potential to transform the landscape of personal stress management. By delivering evidence-based insights into the efficacy of sound frequency technology in enhancing mental wellness, this research could pave the way for more informed, individualized choices in non-clinical anxiety relief methods. While WAVwatch 2.0 may not be universally applicable, its evaluation serves as a critical step towards diversifying and enriching the arsenal of tools available for achieving mental well-being, thus empowering participants to make well-informed decisions concerning their wellness journeys.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Can read and understand English.
  • US resident.
  • Willing and able to follow the requirements of the protocol.

排除标准

  • Individuals with skin sensitivities
  • Individuals with auditory conditions
  • Individuals with severe anxiety or mental health disorders
  • Pregnancy
  • Individuals prone to irritation or frustration

结局指标

主要结局

Perceived Stress Scale (Past Week Version)

时间窗: Change from baseline (Day 1-3) in perceived stress levels at 4 weeks after the start of the intervention (Day 27-33)

The Perceived Stress Scale (Past Week Version) is a modified version of the classic stress assessment tool that evaluates stress levels based on recent experiences within the last week. This scale helps in understanding how various situations have recently affected an individual's feelings and perceived stress levels. By focusing on a shorter time frame, it provides a more immediate assessment of stress, which can be particularly useful for quickly evaluating the effectiveness of stress management strategies or interventions. The tool retains its original structure, ensuring its reliability while making it more relevant for current stress evaluation.

General Anxiety Disorder (GAD-7)

时间窗: Change from baseline (Day 1-3) in anxiety severity at 4 weeks after the start of the intervention (Day 27-33)

The GAD-7 is a 7-item questionnaire used to assess the severity of generalized anxiety disorder (GAD) in adults. The score is based on the responses to seven questions about the frequency of common anxiety symptoms over the past two weeks.

NIH Toolbox® Item Bank v3.0 - General Life Satisfaction (Ages 18+)

时间窗: Change from baseline (Day 1-3) in general life satisfaction at 4 weeks after the start of the intervention (Day 27-33)

This is a survey aimed at assessing the general life satisfaction of individuals aged 18 and above. Participants are asked a series of questions to which they can respond by indicating their level of agreement or disagreement.

Depression, Anxiety and Stress Scales (DASS-21) Survey

时间窗: Change from baseline (Day 1-3) in depression, anxiety, and stress levels at 4 weeks after the start of the intervention (Day 27-33)

The Depression, Anxiety, and Stress Scales (DASS-21) is a widely recognized psychological assessment tool designed to measure the severity of symptoms related to depression, anxiety, and stress. It consists of 21 questions that assess various emotional and psychological factors. Participants are asked to rate the frequency and intensity of their experiences over the past week. The DASS-21 survey provides a quick and reliable way for clinicians, researchers, and individuals to gauge their levels of depression, anxiety, and stress, making it a valuable instrument for mental health assessment and research.

次要结局

未报告次要终点

研究者

发起方
Efforia, Inc
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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