This study is being conducted by SoundHealth, LLC by Drs. Neil Spielholz and R. Robert Sewak, and Dr. Jeffrey T. Baker. The purpose of the study is to determine if:
“Listening, on a daily-basis, to a specially designed audio composition can help to reduce pain and improve emotional or physical function in patients with spinal stenosis?”
Now: THERE ARE SEVERAL VERY IMPORTANT THINGS YOU NEED TO UNDERSTAND…
TAKING PART IN THIS STUDY IS VOLUNTARY. YOU ARE FREE NOT TO TAKE PART OR TO WITHDRAW AT ANY TIME, FOR WHATEVER REASON. NO MATTER WHAT DECISION YOU MAKE, THERE WILL BE NO PENALTY OR LOSS OF BENEFIT TO WHICH YOU ARE ENTITLED. IN THE EVENT THAT YOU DO WITHDRAW FROM THIS STUDY, THE INFORMATION YOU WILL HAVE PROVIDED WILL BE KEPT IN A CONFIDENTIAL MANNER. IF YOU DECIDE TO PARTICIPATE, AND THEN CHANGE YOUR MIND, AND WANT TO QUIT – ALL YOU HAVE TO DO IS TELL US. THAT DECISION IS COMPLETELY UP TO YOU. SO IF YOU DECIDE TO DO SO, JUST LET US KNOW BY CALLING: 561/372-6202 OR SEND US AN EMAIL AT: SUPPORT@SOUND-HEALTH.ORG.
ONLY THE FIRST 20 PEOPLE, SIGNING-UP AND ATTENDING OUR “INSTALLATION MEETING” WILL BE ABLE TO PARTICIPATE IN THE STUDY (WE’LL SEND YOU A PERSONAL NOTICE AS TO WHEN AND WHERE THE INSTALLATION MEETING WILL BE HELD). OUR STAFF WILL BE THERE TO ANSWER ALL OF YOUR QUESTIONS AND EXPLAIN EVERYTHING YOU NEED OR HAVE TO KNOW ABOUT THE STUDY. ALL YOU HAVE TO DO IS: BE THERE!!
THE RESEARCHERS HAVE NOT BEEN MADE AWARE OF NOR HAVE ANY POTENTIAL RISKS BEEN IDENTIFIED AS BEING ASSOCIATED WITH THE PROTOCOLS, APPLICATIONS AND/OR PROCEDURES ATTENDANT TO THOSE BEING EMPLOYED IN THE STUDY.
YOU MAY OR MAY NOT BENEFIT FROM PARTICIPATING IN THIS RESEARCH STUDY. NO PAYMENTS WILL BE MADE FOR PARTICIPATING IN THIS STUDY AND NO INCENTIVES ARE BEING OFFERED FOR PARTICIPATING. THERE IS NO SPONSOR SUPPORT FOR THIS STUDY AND ALL COSTS ARE BEING BORNE BY SOUND-HEALTH.
How do you get started?
As for the paperwork we mentioned – don’t worry – we will help you with all of that, at the “installation meeting,” before you actually start the study. Now, here’s the really exciting part – what you’re going to be listening to. We’re going to be sending to you and audio file over the Internet right to your smartphone via your email address. We will give you earbuds or headphones to listen with. So when you download it, the audio file is on your phone, so you always have it.
Then, all you have to do (each day) is: find a quiet place where you can be comfortable and relax for about an hour… hopefully, without too many interruptions. Make sure your Pain Diary (with a pen) is handy. This is a very important part of the study – here’s why: Your Daily Pain Diary has relevant information about you, each day of the 28 days in the study that you’re be filling in, that we need.
So every day before you listen, you will fill in the following information:
- The date
- Day of the week
- The approximate time of day (am or pm)
- And, your pain and mood rating – all before you listen…
>> Then you listen<<
After you settle-in & settle-down… put on your headphones (or the earbuds) find and click on the file on your phone. Adjust the volume to a comfortable level (JUST LOUD ENOUGH FOR YOU TO HEAR THE SOUNDSCAPE). In fact, you might want to set it so you can BARELY HEAR IT! The important thing is that: it’s NOT too loud.
Now, when the SoundScape is finished (the LISTENING for the day, is over), that’s when you fill out the AFTER section, in the Pain Diary.
So, after you listen… you’ll fill in the following information:
- Rate your pain and mood, again – (AFTER section)
- Mark what “effect” the listening had on you…
- And, if you choose… write down anything else you’d like to tell us, or would like us know. [Again, doing this is up to you… if you’ve done the above, you’ve given us what we need.]
ONE LAST THING…
IF YOU MISS A DAY – PLEASE WRITE THAT DOWN, AT THE BOTTOM OF THE BLOCK OF THE DAY YOU MISSED.
Well, that’s it! Pretty simple and easy, right?
Now, because the “SoundScape” isn’t a song – it won’t be boring… you’ll actually start hearing something new in it, every time you listen. Also, by NOT having the volume turned up loud… THE SOUNDSCAPE WON’T GET IN THE WAY OF WHAT YOU’RE DOING… THINGS LIKE: READING, KNITTING, COMPUTING, WRITING, RELAXING, ETC. – ALL WHILE YOU’RE LISTENING.
Well, that’s all there is too it.
If you have any questions or, need assistance, you can email us at:
email@example.com; or call SoundHealth at: 561-372-6202 and leave a message… someone will get back to you directly.
If you have problems with the equipment we can generally take care of them within a day, after we hear from you. Remember, when you call: be sure to leave detailed message – especially your telephone number – so, we can have the proper person get back to you.