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Recruiting NCT07281989

Sound Stops Stress Study: Evaluating the WAVwatch Effect

No phase Interventional Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WAVWatch 2.0.
Who it may be relevant to
Registry conditions: Stress. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Detailed description

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.

Interventions

  • Device WAVWatch 2.0
    The WAVwatch 2.0, a wrist-worn device intervention, leverages 'calming' frequencies to reduce stress and non-clinically relevant anxiety, aligning with scientific evidence supporting sound therapy's potential.

Primary outcome measures

  • Perceived Stress Scale (Past Week Version) [Time frame: Change from baseline (Day 1-3) in perceived stress levels at 4 weeks after the start of the intervention (Day 27-33)]
  • General Anxiety Disorder (GAD-7) [Time frame: Change from baseline (Day 1-3) in anxiety severity at 4 weeks after the start of the intervention (Day 27-33)]
  • NIH Toolbox® Item Bank v3.0 - General Life Satisfaction (Ages 18+) [Time frame: Change from baseline (Day 1-3) in general life satisfaction at 4 weeks after the start of the intervention (Day 27-33)]
  • Depression, Anxiety and Stress Scales (DASS-21) Survey [Time frame: Change from baseline (Day 1-3) in depression, anxiety, and stress levels at 4 weeks after the start of the intervention (Day 27-33)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

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

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Efforia — New York

Identifiers

NCT: NCT07281989 · 37459

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗