NCT02328690

The Sound Mind Warrior Study

Binaural Beat Technology: A Complementary Path to Post Deployment Wellness (The Sound Mind Warrior Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Fort Belvoir Community Hospital · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this prospective, double-blind, repeated measures study is to assess the efficacy of Binaural Beat Technology (BBT) on anxiety and anxiety related cardiovascular measures as well as to assess the feasibility of implementing a BBT intervention in a military population during the high risk post-deployment window.

Detailed description

The purpose of this prospective, double-blind, repeated measures study is to assess the efficacy of Binaural Beat Technology (BBT- a sound technology that uses special tones \[embedded in music\] through stereo headphones to affect your brainwaves in order to put you in a more relaxed state) on anxiety and anxiety related cardiovascular measures as well as to assess the feasibility of implementing a BBT intervention in a military population during the high risk post-deployment window. A sample of 74 Warriors who have deployed will be randomly placed into two groups (music with BBT and music without BBT). Each group will be exposed to their respective intervention for 30 minutes at bedtime, 3 times a week, for 4 weeks. Quantitative and qualitative measures will be collected as follows… 1. Cardiovascular reactivity, c-reactive protein, and state anxiety measures will be collected at baseline and after the 4 week intervention. 2. Morning blood pressure (BP) surge and evening BP decline measures will be collected at baseline and weeks 0, 2 and 4. 3. Input from the participants will be collected via daily logs and at the completion of the 4 week intervention. Aim 1 - To assess the feasibility of implementing a binaural beat technology intervention in a military population during the high risk post deployment window. Feasibility will be measured by assessing: 1. retention 2. number of refusal during recruitment 3. number of drop outs 4. reason for drop outs 5. reason for staying 6. number of days the technology was used 7. selection of music 8. ease of use and comfort of equipment 9. adherence to the protocol 10. evaluation of recruitment strategies Aim 2 - To assess the impact of binaural beat technology on anxiety and relevant CV health measures. These measures included: 1. Comparison of pre and post intervention state anxiety scores 2. Observing the trend of morning blood pressure surge over time 3. Observing the trend of evening blood pressure decline over time 4. Comparison of pre and post intervention heart rate variability measures 5. Comparison of pre and post intervention c-reactive protein measures

Conditions

• Anxiety
• Stress

Interventions

Type	Name	Description
OTHER	Binaural Beat Technology	A phenomenon when two nearly similar frequencies (between 30-1000 hertz \[Hz\]) are presented to each ear and the brain detects the difference between the two sounds. These two sounds are processed in the superior olivary nucleus of each hemisphere of the brain. This integration of brain hemispheres produces a frequency that in turn affects the reticular activating system which alters the electrical potentials of the thalamus and cerebral cortex changing brainwave frequency.

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-12-31
• Last updated: 2017-05-30

Locations

2 sites across 1 country: United States