Your privacy is very important to us. We will be doing everything in ensure your information is kept safe and your responses to surveys will be completly confidential. The purpose of this study is to design and use a mindfulness/awareness-based pain management application for adults with sickle cell disease (SCD) at The Ohio State University Wexner Medical Center. Since SCD related pain can be difficult to manage, the option of using a mobile app could potentially be an additional (to the medications that you take), accessible option and help improve the quality of life for patients with SCD. The research team will ask you to provide feedback on the mobile app layout and user friendliness. In addition, the research team will be analyzing your anonymous answers to surveys to see if the program worked well for you.
The anticipated potential risks are loss of privacy, negative feelings that may arise during or after completing the measures and/or interviews (e.g. embarrassment, frustration, anger), fatigue as a result of being interviewed, and temporary changes in pain as a result of fatigue. Loss of privacy can occur if data files are breached during data collection, transmission or storage, or if someone is able to attribute a quote or details in a publication to an individual participant. It is not guaranteed that you will benefit directly from participating in this research study. However, participating, answering surveys, and providing feedback may contribute to your own well-being, by helping others to understand some adaptive ways you have used to deal with pain. It is hoped that the results of this study will be useful to understand SCD pain management, and possibly help design clinical trials in the future that may assist patients with SCD.
If you have any questions, concerns, or comments about the app related to rights or privacy please reach out to the following:
Office for Human Research Protections or other federal, state, or international regulatory agencies
The Ohio State University Institutional Review Board or Office of Responsible Research Practices: The sponsor, if any, or agency (including the Food and Drug Administration for FDA-regulated research) supporting the study
You may refuse to participate in this study without penalty or loss of benefits to which you are otherwise entitled. If you are a student or employee at Ohio State, your decision will not affect your grades or employment status.
If you choose to participate in the study, you may discontinue participation at any time without penalty or loss of benefits. By agreeing to participate, you do not give up any personal legal rights you may have as a participant in this study.
An Institutional Review Board responsible for human subjects research at The Ohio State University reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare of participants in research.