RLS during Pregnancy on line survey
Participant Information Sheet

1. TITLE OF RESEARCH PROJECT
Restless Legs Syndrome (RLS/WED) during Pregnancy. An online survey.

Name of Researchers:
Georgios K. Sakkas PhD, Gary Shum PhD, Sherry Choy MSc, Christina Karatzaferi PhD
Plymouth Marjon University, PL6 8BH, UK.

Restless Legs Syndrome/Willis-Ekbom Disease (RLS/WED)is a sensorimotor disorder affecting 4% of the general population. Notably, RLS/WED affects 34% of the pregnant women being 3-fold more prevalent in pregnant than in non-pregnant women. Symptoms, particularly strong and frequent at the third trimester, have been associated with a number of complications in pregnancy including preeclampsia, depressed mood and insomnia.
Dr Sakkas and team members have been involved in many clinical trials investigating various therapeutic options for helping patients with RLS cope with their disease.

What is the purpose of the study?
The focus of the current project is to gather information in order to support a research project that will seek alternative non-pharmacological approaches for the management of Restless Legs Syndrome/Willis-Ekbom Disease (RLS/WED) symptoms during pregnancy and postpartum.
RLS/WED is a distressing and common neurological disorder that has a huge impact in the quality of life. Patients complain of unpleasant sensations in the legs, at or before bedtime, and of feeling an urge to move their legs, which improves with movement, such as walking. Symptoms start with the patient at rest (e.g. sitting or lying down), and follow a circadian pattern, increasing during the evening or at night. The prevalence in the general population is appx 4-7% , becoming much higher in secondary forms of the syndrome (40% in renal patients, 34% in pregnant women, etc).
RLS/WED affects approximately one in three pregnant women in Western countries with a negative impact on sleep and quality of life. It is also linked to postpartum depression which harmful consequences for both mother and child. According to the consensus clinical practice guidelines for the diagnosis and treatment of RLS/WED during pregnancy and lactation the first line of treatment should be “non-medication” since all pharmacological approaches are related to high levels of risk for congenital anomalies.
The current project aims to support the development of a new research application and to lead to the acquisition of data that could help us improve the management of RLS/WED in a population for which the use of pharmacological agents should be avoided.

Why have I been invited?
You have been invited because you are a member of the RLS-UK charity.

Do I have to take part?
Your participation in this online survey is voluntary and anonymous. In order to participate, you need to read and click the consent button. By clicking the consent button, you consent your intention to participate. You can withdraw at any time during the completion of the survey but after you press the submit button it will not be possible to withdraw the submitted data (due to the anonymization process).

What will happen to me if I take part?
If you decide to participate you will have to answer 52 questions related to demographic and RLS characteristics. It will take you approximately 15 min to read and consent as well as to complete the online survey.
The data acquired will be totally anonymous and there is no means of tracing participant’s IP address or other details that might lead to a participant’s identification. The data will be used to develop a new non-pharmacological intervention for reducing RLS symptoms in pregnant women. The data will be kept for 10 years and will be stored in an encrypted and password protected university network folder. Data will be appropriately destroyed after the end of the 10-year period. Again, the data collected will be anonymous and accessible only by the main investigators within Plymouth Marjon University.

Expenses and payments
No compensation is available for the participants of this survey.
What will I have to do?
It is expected from you to start the survey by clicking the Consent button. The survey will guide you through all the steps you need in order to successfully complete it.
What are the advantages of taking part?
There are no direct advantages of taking part in this survey apart from supporting academic research that aims to help patients. However, we hope that this survey will lead to the design of an intervention that will help pregnant women with RLS/WED manage their symptoms and improve their quality of life.


What are the possible disadvantages and risks of taking part?
A potential disadvantage is the fact that due to the automatic anonymization procedure there is no procedure in place for you to gain access to your own answers, should you wish to, at a later date. However, when a research article or report presenting the survey outcomes will be published, it will become freely available via the charity’s website and social media platforms linked to the project. The potential risks to you are minimal at the formative evaluation stage although there is an acknowledgement that by the process of asking questions about your symptoms your stress levels may increase temporarily. If you feel uncomfortable with discussing aspects related to RLS symptoms, please do not participate in this survey.

Will my taking part in the study be kept confidential?
There is no way to identify you through this online survey and therefore confidentiality is fully respected.
What will happen if I don’t want to carry on with the study?
Your participation in this online survey is voluntary and anonymous. You can quit anytime during the completion of the survey (by closing your browser) but after you press the submit button it will not be possible to withdraw the submitted data (due to the anonymization process). In order to participate, you need to read and click the consent button. By clicking the consent button, you consent to participate but you can withdraw from the survey anytime before you press the “submit” button.

What if there is a problem?
The possibility of having a problem during the completion of the online survey is minimal. The easiest way to correct some potential malfunction is to quit the survey by closing your browser and restart a new one. Unfortunately, this is the only way to secure the anonymity of your participation and therefore we have removed all the possible ways for you to communicate with us during that process. In case that you would like to reveal your details, there is an option to email us at any time.

What will happen to the results of the research study?
Findings from the study will be reported, disseminated and made available to the participants via the charity’s website and social media platforms linked to the project. It is intended that this work will be published in a peer-reviewed journal however key findings will be made available to participants regardless of publication through the RLS-UK charity website and Facebook page. The independence of research will be stated and any conflicts of interest or partiality will be made explicit should any arise. Currently there is no conflict of interest to report.
Thank you for taking the time to read the information sheet. In case you would like to keep some of this information, you can always print the pages from the online survey by clicking “print” from the menu options of you browser.

Giorgos K. Sakkas PhD
Associate Professor in Health Sciences
Faculty of Sport & Health Sciences
Plymouth Marjon University
Plymouth, PL6 8BH, UK

T: +44 (0)1752-636837
gsakkas@marjon.ac.uk

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