Materials & Methods
This study was a cross-sectional, comparative analysis of current adults using Somacoustics for stress management. Participants were recruited from a marketing email sent by the manufacturer to individuals who purchased the novel device before June 2022. In addition, a link was provided on the manufacturer’s social media accounts to encourage consumer participation. Inclusion for this study were adults (> 18 years of age) who were consistent users of the novel device (> 3 days per week) between one to six months. There were no incentives offered for participation.
Individuals were assigned to either a group with or without a self-reported diagnosis of an emotional disorder (e.g., Anxiety, Obsessive Compulsive Disorder, Post-Traumatic Stress Disorder, and Depression). The research dataset was obtained following Human Subject Regulations 45 CFR Part 46 and per the principles stated in the Declaration of Helsinki. Ethics approval was obtained by Grand Canyon University Institutional Review Board (#2023-5336).
An online survey was developed using Google Forms. The form was password protected, and only the researcher had access to the development and individual responses. Each question was an optional response, and participants could stop the survey anytime. Before beginning the survey, participants were informed of the purpose and the study. Participants acknowledged consent by agreeing to participate in the study. Survey questions were offered as either multiple-choice or multiple-checkbox responses. Participants were asked about their stress experiences prior to using the novel device. The historical stress assessment included standard terms for referencing stress (e.g., anxious, nervous, jittery, scared, worry, and dread). These questions were not previously validated but are standard terms used to assess prior stress (Cohen, Kamarck, & Mermelstein, 1983).
Perceived stress was assessed with the Perceived Stress Scale-10 (Cohen, Kamarck, & Mermelstein, 1983). The PSS-10 instrument includes ten questions based on the original 14-item questionnaire that assesses how an individual perceives their current situation as unpredictable, uncontrollable, and overloaded. Each response is coded to a five-point Likert scale (0= never to 4=very often-4 pts) with a maximum score of 40 pts. The scale demonstrates acceptable consistency, validity, and reliability in several demographics and is commonly used in stress research (Cohen & Janicki-Deverts, 2012; Lee, 2012). Higher PSS-10 scores indicate more significant perceived stress (Cohen, Kamarck, & Mermelstein, 1983).
Positive and negative affect was assessed with the Positive and Negative Affective Scale (PANAS) (Watson, Clark, & Tellegen, 1988). Positive affect assesses emotional constructs related to determination, enthusiasm, inspiration, and excitement. Negative affect assesses emotional constructs related to distress, fear, irritability, and nervousness. This questionnaire consists of 10 positive affect traits (e.g., PA; interested, excited, strong, enthusiastic, proud, alert, inspired, determined, attentive, and active) and ten negative affect traits (NA; distressed, upset, guilty, scared, hostile, irritable, ashamed, nervous, jittery and afraid) (Watson, Clark, & Tellegen, 1988). Each response is coded to a five-point Likert scale A( 1= not at all, to 5= extremely). PANAS is commonly used in positive/negative affective research, and higher scores (10-50 pts) represent more significant positive or negative affect. The instrument has high internal consistency and intercorrelations when assessing effect within a few weeks (PA=.87, NA=.87, and r=-.22) (Watson, Clark, & Tellegen, 1988). Prior research has demonstrated PANAS to be correlated with the Beck Anxiety Inventory, State Anxiety Scale, and Beck Depression Inventory (Díaz-García et al., 2021; Díaz-García et al., 2020, Serafini, Malin-Mayor, Nich, Hunkele, & Carroll, 2016; Watson, Clark, & Tellegen, 1988).
Finally, a brief assessment of perceived changes in an emotional disturbance was included in the survey. Participants who reported being diagnosed with an anxiety or depressive order were asked if changes occurred in their condition (Worsened, No Change, Improved, or Greatly Improved). The survey was administered in August 2022, and the survey questions, minus PSS-10 and PANSAS, are included in Appendix II.
Each instrument was coded as ratio and ordinal measures. Once coding was complete, the file was saved and imported to IBM SPSS v27 for statistical analysis. The sample size was based on approximate PSS-10 scores of those with emotional disturbance to be 4 pts higher than a baseline PSS-10 score of 19 (Meaklim et al., 2021; TMGH-Global COVID-19 Collaborative, 2021; Agyapong et al., 2020). Assuming a pooled standard deviation of 6.5 pts (Meaklim et al., 2021; TMGH-Global COVID-19 Collaborative, 2021; Agyapong et al., 2020), an estimated sample of 84 participants (42 per group) to achieve a power o 80% and a significance of 5% ( two-sided) was determined (Dhand & Kahtkar, 2014). An independent sample t-test was used to assess possible differences between PSS-10 and PANAS. In addition, cross-tabulations using a chi-square analysis were performed on prior historical stress. A one-sample chi-square goodness of fit (GOF) test was used to assess the proportion of responses for perceived changes in emotional disorders. The alpha for this study was set at 95% (p<.05).