Sound Stops Stress Study: Evaluating the WAVwatch Effect
ConditionStress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEfforia, Inc
About this trial
Sound Off Stress Study seeks to discover if WAVwatch 2.0-a sleek, wearable sound frequency device-can support mental harmony.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Can read and understand English.
US resident.
Willing and able to follow the requirements of the protocol.
Disqualifiers
Individuals with skin sensitivities
Individuals with auditory conditions
Individuals with severe anxiety or mental health disorders
Pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
WAVWatch 2.0
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Single arm where participants act as their own controlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Perceived Stress Scale (Past Week Version)
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.
Time frame
Change from baseline (Day 1-3) in perceived stress levels at 4 weeks after the start of the intervention (Day 27-33)2
General Anxiety Disorder (GAD-7)
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.
Time frame
Change from baseline (Day 1-3) in anxiety severity at 4 weeks after the start of the intervention (Day 27-33)3
NIH Toolbox® Item Bank v3.0 - General Life Satisfaction (Ages 18+)
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.
Time frame
Change from baseline (Day 1-3) in general life satisfaction at 4 weeks after the start of the intervention (Day 27-33)4
Depression, Anxiety and Stress Scales (DASS-21) Survey
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.
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)Sponsors and contacts
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Source ClinicalTrials.gov