Sleep, Health and Wellness Project
What is the purpose of this study: This study is concerned with the effect that amount of night-time sleep has on daytime mood and blood pressure. You have been asked to take part because significant insights can be gained by examining healthy people. We will ask you to report your mood using standard forms for that purpose, and we wish to measure your blood pressure at rest and while you perform some computer tasks. We also wish to measure your blood pressure as you go about your usual business at work.
Do I have to take part? It is up to you to decide whether or not to take part. If you do decide to take part you will be given an information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect your rights in any way.
What will happen to me if I take part? We will ask you to answer some standard questionnaires that ask you about your general health and lifestyle (e.g., whether you are a smoker, drink alcohol, your sleep patterns, etc.). We also wish to measure your blood pressure at rest and while you perform some computer tasks. In addition, we wish to measure your blood pressure throughout one day, using a small portable device that you carry in a pouch on your hip. This device measures your blood pressure as you go about your daily activities. We also wish to take a few saliva samples during the day. Relating these measurements to one another will allow us to see how mood and sleep patterns affect blood pressure overall.
How long will my part in the study last? In total, your participation will last approximately nine hours. However, for eight of these hours, participation means wearing the small blood pressure device as you go about your daily activities. On a separate day, we will ask you to visit our research laboratories in NUI Galway to complete a number of computer tasks while we monitor your blood pressure. This visit will take less than 60 minutes.
What are the possible benefits in taking part? You will learn something about your general level of cardiovascular fitness and the factors that affect blood pressure level. We will also give you a report on your blood pressure throughout the eight-hour period when you are wearing the blood pressure device, which we will discuss with you. You can also take this report with you and discuss it further with your General Practitioner if you wish. We will also cover any expences you may incur as a result of participation.
What are the possible disadvantages and risks of taking part? The blood pressure monitor you will wear during the day may be an inconvenience (you cannot shower or go swimming while wearing the monitor), though the device is entirely harmless. We are interested in monitoring your blood pressure while you work, and this device should not impede on your work-related activities. Also, this study includes questionnaires that measure your feelings and well-being now and in the recent past. You might find while you are answering them that you would like to talk to someone about some of the issues raised. We will be happy to recommend someone to you.
I’m over 65 and don’t work: Can I still take part? Yes! We’re interested in recruiting individuals over the age of 65 and who are no longer in full-time employment or have never worked outside of the home. For these individuals, we will ask you to wear the ambulatory blood pressure monitor for 8 hours during your day, or if you wish, for a 24-hour period.
What happens at the end of the study? When all participants have been tested (this should be within 12 months of your participation), you will receive a summary of our main findings. While it could be up to 2 years before final results are published, we would be pleased to include you on an address list to receive publications arising from the study. Only general findings will be reported, without reference to identifiable individual results. You will also receive an individualised summary of your blood pressure and questionnaire data.
What happens if I change my mind during the study? Your participation is voluntary, and you are free to withdraw at any time without giving any reason and without your rights being affected in any way.
Whom do I contact for more information or if I have further concerns? If you would like further information or have concerns, you should contact the Project Manager:
Dr. Siobhán Howard, School of Psychology, NUI Galway firstname.lastname@example.org Ph: (091) 494069
Confidentiality: All information that is collected about you during the course of the research will be kept strictly confidential and will not be shared with anyone else. The information collected in this research study will be stored in a way that protects your identity. Results from the study will be reported as group data and will not identify you in any way.
If you are interested in participating in this this study, or you wish to receive further information, please email email@example.com