Daily Activity: Use the WAVwatch at the time you're most likely to feel stressed, selecting a calm-supportive frequency from the Stress & Relief Program. Set volume, secure the watch on your non-dominant wrist, and press play. Use daily during high-stress times, staying hydrated and limiting use to 6–8 hours a day.

• Various Scales: Complete the General Anxiety Disorder (GAD-7), Perceived Stress Scale, Depression, Anxiety, and Stress Scales (DASS-21), and NIH Toolbox® Item Bank v3.0 – General Life Satisfaction assessments as part of the study.

The Sound Stops Stress Study: Evaluating the WAVwatch Effect is designed as a single-arm observational trial where participants serve as their own controls to explore the efficacy of the WAVwatch 2.0, a wearable sound frequency device, in reducing stress and anxiety. Participants will engage in a daily routine using the device to assess its impact on their mental well-being. The study aims to provide initial insights or a "signal" on whether this non-clinical intervention can effectively alleviate stress, thus offering a preliminary indication of potential positive outcomes. This trial will also gather valuable safety data, contributing to the understanding of the device's safety profile, which is currently limited.

The Sound Off Stress Study invites participants to take an active role in managing their anxiety through the WAVwatch 2.0 by utilizing sound frequencies intended for stress relief. Participants will use the device for 64 minutes daily, collecting data about their individual experiences and responses. The study's methodology allows researchers and participants alike to assess the practical benefits of the WAVwatch in real-time, offering personalized feedback throughout the process. The study's design emphasizes the importance of participant consistency, as regular use will enhance the clarity and utility of the collected data. By the study's conclusion, participants will receive detailed progress reports to aid their understanding and inform future decisions regarding stress management.

Participants are encouraged to incorporate the WAVwatch 2.0 into their daily routine, using it during periods of heightened stress or anxiety. The study provides a daily check-in guide to help maintain consistency. Participants will choose a calming frequency, set an appropriate volume, secure the device on their wrist, and engage the playback feature. The trial limits usage to 6-8 hours per day to optimize effectiveness and battery life. Through this consistent daily engagement, participants will contribute to a meaningful data set that may indicate the WAVwatch's efficacy. Should the study yield positive results, suggesting the WAVwatch effectively reduces stress, more comprehensive and robust study designs will be pursued to further validate these initial findings. For further details on this protocol, please refer to the "Minimal Risk Umbrella protocol."

Thank you for submitting the protocol titled "Sound Stops Stress Study: Evaluating the WAVwatch Effect" for review. As an IRB reviewer, it is important to ensure that the statistical plan for your study is consistent with the Minimal Risk Umbrella protocol under which it is categorized.

Your study involves the assessment of stress and anxiety relief using the WAVwatch 2.0 device, and you have outlined a plan to measure outcomes using several validated tools: the General Anxiety Disorder (GAD-7) survey, the Depression, Anxiety and Stress Scales (DASS-21) survey, the NIH Toolbox® Item Bank for General Life Satisfaction, and the Perceived Stress Scale (Past Week Version).

The statistical plan appears to be in alignment with the umbrella protocol, as these measures will be used to evaluate the baseline and outcome scores, thereby assessing the effectiveness of the WAVwatch 2.0 device in reducing stress and anxiety. The focus on both baseline and outcome periods helps in understanding any changes or improvements in participants' mental health status.

For reviewers who wish to delve deeper into the statistical methodologies and ensure they are consistent with the guidelines set within the Minimal Risk Umbrella protocol, it is recommended to review the statistical plan in detail within the context of the umbrella protocol. This review will ensure that any statistical analyses, including the handling of data and interpretation of results, align with the minimal risk standards and ethical considerations laid out in the overarching protocol.

Please ensure that all statistical analyses are transparent, justified, and appropriately account for the study's design and objectives. This will not only facilitate a thorough review but also uphold the integrity and validity of the study findings.

The single-arm observational trial investigating the WAVwatch 2.0's efficacy in stress and anxiety reduction is inherently limited by the absence of a control group, which introduces susceptibility to bias and challenges in establishing causality. To mitigate this, the study employs an expectations questionnaire to quantify participant bias, offering insights into how expectations may influence outcomes. Despite these efforts, the lack of a control group remains a notable limitation, as it restricts the ability to definitively attribute changes in stress and anxiety levels directly to the intervention. However, the study is designed as a preliminary signal detection study, meaning that its primary goal is to identify potential associations which, if promising, will pave the way for more rigorous, controlled trials in the future.

Additionally, the study's sample size and statistical methodology are carefully structured to address potential biases and improve data interpretation. Stratification by participant demographics allows for a nuanced analysis of how different subgroups may respond to the WAVwatch 2.0, providing a more comprehensive understanding of its effectiveness across diverse populations. This approach is aligned with the Minimal Risk Citizen Science Umbrella Protocol's objective to democratize research by supporting inquiries and researchers that may otherwise be overlooked. By prioritizing inclusivity and diversity, the study aims to deliver insights that are both scientifically valuable and socially relevant, aligning with the broader mission of Efforia to make clinical research more accessible and equitable.

Finally, while the study's primary focus is on identifying initial signals of effectiveness, it also serves to empower participants with personalized insights into their mental wellness journeys. By measuring changes in standardized metrics such as GAD-7, DASS-21, and NIH Toolbox® scores, participants can better understand their responses to the WAVwatch 2.0, enabling more informed decisions about future stress management strategies. This personalized feedback loop not only enhances participant engagement but also underscores the potential of sound frequency technology as a non-invasive alternative for managing stress and anxiety. Should the study yield positive results, subsequent research will aim to validate these findings through more robust study designs, ensuring that any identified benefits are rigorously tested and substantiated. For further details on the study's framework and objectives, interested individuals are encouraged to consult the Minimal Risk Umbrella Protocol.