Sick and Tired: Understanding and Managing Sleep Difficulties in ...
Sick and Tired: Understanding and Managing Sleep Difficulties in ...
Sick and Tired: Understanding and Managing Sleep Difficulties in ...
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Appendix N. Participant Information Sheet <strong>and</strong> Consent Form for Study Four<br />
(Chapter Seven)<br />
INFORMATION SHEET<br />
Relaxation <strong>in</strong> Fibromyalgia Syndrome<br />
You are be<strong>in</strong>g <strong>in</strong>vited to take part <strong>in</strong> a research study. Before you decide it is important<br />
for you to underst<strong>and</strong> why the research is be<strong>in</strong>g conducted <strong>and</strong> what it will <strong>in</strong>volve.<br />
Please take time to read the follow<strong>in</strong>g <strong>in</strong>formation carefully <strong>and</strong> discuss it with others if<br />
you wish. Please ask us if there is anyth<strong>in</strong>g that is not clear or if you would like more<br />
<strong>in</strong>formation.<br />
What is the purpose of the study?<br />
People with Fibromyalgia commonly experience sleep difficulties. This study aims to<br />
explore the effects of two types of relaxation technique on sleep<strong>in</strong>g <strong>and</strong> quality of life.<br />
This research study will be run over 6 months <strong>in</strong> total. Your participation <strong>in</strong> this study<br />
will last for 3 weeks.<br />
Why have I been chosen?<br />
You have been chosen to take part as you have been identified as hav<strong>in</strong>g Fibromyalgia<br />
syndrome. There will be approximately 39 other participants tak<strong>in</strong>g part.<br />
Do I have to take part?<br />
It is up to you to decide whether or not to take part. If you do decide to take part you<br />
will be asked to sign a consent form. You are still free to withdraw at any time, without<br />
giv<strong>in</strong>g a reason. A decision to withdraw at any time, or not to take part <strong>in</strong> the study,<br />
will not affect your current care.<br />
What will happen to me if I take part?<br />
If you would like to take part <strong>in</strong> this study you will be <strong>in</strong>vited to attend an <strong>in</strong>itial<br />
assessment meet<strong>in</strong>g with a researcher. The assessment meet<strong>in</strong>g will be at a time <strong>and</strong><br />
location that is convenient for you, if it is easier the assessments may be completed over<br />
the telephone. At the start of the assessment you will have the opportunity to ask any<br />
further questions you have about the study. You will then be asked to complete some<br />
questionnaires about your sleep patterns <strong>and</strong> quality of life, you will also be given<br />
<strong>in</strong>structions on how to use the relaxation audio <strong>and</strong> daily sleep diary.<br />
What do I have to do?<br />
The sleep diary will be completed for three weeks; the first week is to establish a<br />
basel<strong>in</strong>e measure of your sleep patterns. The second week you will be r<strong>and</strong>omly<br />
assigned to do<strong>in</strong>g one of two types of relaxation exercise, either a „body scan‟ exercise<br />
or an „isometric exercise‟. You will need to practice the relevant relaxation technique<br />
on a daily basis for one week whilst keep<strong>in</strong>g your sleep diary. The third week will be a<br />
post-relaxation exercise week where aga<strong>in</strong> you will need to complete a sleep diary.<br />
This will help us to underst<strong>and</strong> the effects of relaxation on sleep <strong>and</strong> Fibromyalgia<br />
better.<br />
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