Introduction/Purpose
You are invited to participate in a voluntary research survey on understanding the role of stress on postpartum psychological and sexual functioning, including experiences of distress during childbirth and psychological distress in the postpartum period. Adult women who have recently given birth (i.e., within the last 12 weeks) are being asked to participate. The research project is being conducted by Erika L. Kelley, PhD, Clinical Psychologist at University Hospitals. There will be two groups of participants and each group will complete one online survey that will take approximately 15-20 minutes to complete. One of the groups will be asked to complete an additional online survey approximately 6 months postpartum that will take approximately 15 minutes to complete.
Participation
Your participation in this survey is voluntary. You may refuse to take part in the research or exit the survey at any time without penalty. You are free to decline to answer any particular question you do not wish to answer for any reason. We hope to gather responses from about 250 individuals. You will be asked to complete online surveys asking about your experience of stress before and during pregnancy, including experiences of discrimination, and history of unwanted sexual experiences, and potentially stressful characteristics of your childbirth experience (such as emergency c-section or postpartum hemorrhage). You may also be asked to describe your experience with psychological symptoms (like nightmares and negative emotions) and sexual functioning.
You will be randomly assigned to just one of these groups. Randomization means that the group you are in is assigned by chance, like the flip of a coin. Your chance of being in either group is equal. Participants in both groups will be asked to complete an online survey within 12 weeks following your recent childbirth experience. Participants in one of the groups will also be asked to complete a second online survey, approximately 6 months postpartum. You will be provided with a link to complete the survey and may complete the survey at a location and on a computerized device of your choosing. We do recommend that you complete the survey(s) individually/alone and in a private setting.
Benefits
There will be no direct benefit to you by your participation in this research study. Your participation in this study might help us understand how various forms of stress can influence postpartum women's psychological and sexual functioning. We hope that the knowledge gained will help us benefit others like you in the future.
Risks
There is no physical risk to being in this study. There is always the risk that your information may be seen someone who shouldn't have access. We will work to prevent this by following the plan laid out in the Confidentiality section below.
Some individuals might experience emotional discomfort while answering some of the questions. You may feel upset, distressed, anxious, sad, or otherwise uncomfortable answering survey questions. This risk is usually minimal and transient. In addition, you will be able to skip any question you do not wish to answer and move on in the survey.
If you would like to discuss your reactions to the content assessed in this study, have specific worries, or otherwise would like to be contacted by the Primary Investigator directly, you will be given the opportunity in the survey to provide your name and contact information. If you do, you will be contacted by the Primary Investigator within 48 hours of your submission. It may be up to 48 hours before you are contacted. Please be aware that this will also mean your contact information is then linked to your survey responses. You do not need to enter your name and contact information if you do not want to be contacted by the Primary Investigator. You may also contact the Primary Investigator directly, Erika L Kelley, PhD, at 216-286-3971. If you need more immediate/urgent assistance, please contact FrontLine Services, a 24/7 crisis hotline at 216-623-6888.
Alternatives to Study Participation
The alternative to participation in this study is to NOT participate. This will not affect your care in any way.
Financial Information
Your participation in this study will not involve cost to you or your insurance company.
You will be compensated for your participation with a $10.00 electronic gift card after completing the first study survey. In order to receive the gift card, you will be given a link to provide contact information for delivery of the gift card. Your contact information will be permanently removed from the form prior to data analysis and will not be linked to your research information.
Confidentiality
There is a small risk of a breach of confidentiality, but all efforts will be made to keep your personal information including email address in the strictest confidentiality.
Your survey answers will be collected within the University Hospitals REDCap survey tool, where data will be stored in a password protected electronic format. Your responses will be kept confidential and your email address will only be used for the purpose of providing you with a signed copy of this consent form and to send your electronic gift card. However, if you do provide your name and contact information in the Optional PI Contact form in the survey (i.e., if you wish to be contacted by the PI to discuss your emotional reactions), then your survey data will be linked to your name. No names or identifying information would be included in any publications or presentations based on these data, and your responses to this survey will remain confidential.
If identifiers are removed from your responses that are collected during this research, that information could be used for future research studies or distributed to another investigator for future research studies without your additional informed consent. We will remove or code any personal information that could identify you before files are shared with other researchers to ensure that, by current scientific standards and known methods, no one will be able to identify you from the information we share. Despite these measures, we cannot guarantee anonymity of your personal data.
It is possible, that in the future, additional research sites may be added. In this event, the data collected during this research project may be shared with research personnel at these additional sites.
Students or Employees
Choosing not to participate or withdrawing from this study will not affect your employment or class standing, nor will the results be shared with your supervisors or professors.
Summary of your rights as a participant in a research study
Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits. Deidentified data from this study may be published, presented, or otherwise made publically available. If this happens, your identity will not be revealed.
Contact Information
If you have questions at any time about the study or the procedures, you may contact Erika L. Kelley, PhD, via phone at 216-286-3971; please indicate the reason for your call on voicemail or via email at womenshealthresearch@UHhospitals.org. If you have any questions, concerns, or complaints about the study in the future, you may also contact them later.
If the researchers cannot be reached, or if you would like to talk to someone other than the researcher(s) about; concerns regarding the study; research participant's rights; research- related injury; or other human subject issues, please call the University Hospitals Cleveland Medical Center's Research Subject Rights phone line at (216) 983-4979 or write to: The Associate Chief Scientific Officer, The Center for Clinical Research, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061.