The Association of Pain, Sleep, and Occupational Engagement on Quality of Life in People Diagnosed with Complex Regional Pain Syndrome

Title of Study:

The Association of Pain, Sleep, and Occupational Engagement on Quality of Life in People Diagnosed with Complex Regional Pain Syndrome

Why is this study being done?

We want to understand what it is like to live with CRPS. This study will look specifically at how sleep, pain, and doing the activities that are important to a person can impact living with CRPS. There is not much research on sleep in CRPS. We think sleep, pain, and activity levels might work together to make things better or worse. If we can show the importance of sleep to understand the overall life experience of people with CRPS, doctors and therapists may ask about sleep more. It may also help us to develop new ways of improving sleep in people with CRPS.

How many participants will participate and how long will the study take?

We want to hear from at least 150 people living with CRPS. We need people to fill in the whole questionnaire. The study will collect questionnaires for 60 days.

Inclusion criteria:

You can be part of this study if you are at least 18 years old and have been diagnosed with CRPS. You will need to be able to read and write in English. You also will need to be able to use the online survey platform (called Qualtrics) on an electronic device, like a computer, phone or tablet.

What will happen if I take part in this study?

If you choose to participate in this study, we will ask you questions about yourself and your health on a survey. We will also ask you to fill out some electronic questionnaires about how you sleep and your pain. We will also ask about the activities you do every day, and your quality of life.

Estimated time commitment:

The estimated time to complete is approximately 25-30 minutes.

Will there be any cost to you to take part in this study?

There will be no monetary cost to participate in this study. There is a minimum time commitment of 25-30 minutes.

Will you be paid to take part in this study?

Participants will not be paid to take part in this study.

Participation is Voluntary

Participation in this study is voluntary and you may decide to stop participation at any time. There will be no repercussions for not participating in this study.

What are the risks and/or discomforts you might experience if you take part in this study?

There are no known risks and/or discomforts associated with participation in this study. No responses will be associated with your name and data analysis. In addition, your personal identification number will be stored securely. If you should choose to withdraw from the study, all de-identified data will be stored separately from the data used in this research.

Are there any benefits for you (or for others) if you choose to take part in this research study?

There are no direct benefits to participating in this study. You may indirectly benefit from the outcomes of the research.

Will my study-related information be kept confidential?

The principal investigator will have access to your identified responses. This researcher will assign participant numbers and de-identify the data. The principal investigator will use the de-identified data for data analysis. Your consent form and information obtained for analysis will be kept confidential in an encrypted drive approved to protect sensitive information. Efforts will be made to keep your study-related information confidential. However, there may be circumstances where this information must be released. For example, personal information regarding your participation in this study may be disclosed if required by state law.

Your records may be additionally reviewed by: Office for Human Research Protections or other federal, state, or international regulatory agencies Northern Arizona University Institutional Review Board or Nova Southeastern University Institutional Review Board Information that may identify you may be used for future research or shared with another researcher for future research studies without additional consent.

Future Research

As a part of this informed consent, by proceeding with the survey, you agree to the use of your anonymized/deidentified data for future analyses. Future analyses of data beyond this particular research question will serve as rich data to answer additional research questions advancing what is known about CRPS.

Who can you contact with questions?

If you have any questions or concerns you can contact the principal investigator, Gretchen Bachman, at gretchen.bachman@nau.edu. If you would like to obtain information on the results of this study after completion, please contact the principal investigator.

Thank you for your consideration in participating in this important research.

Please click here for the survey

Gretchen Bachman, OTD, OTR/L, MBA, CHT