How do we recruit and retain people with pregnancy-related pelvic girdle pain to research studies?
Participant information sheet
You are being invited to take part in a research study. Before you decide whether or not to take part in the study, it is important for you to understand why the study is being done and what it would involve. Please take the time to read the following information carefully.
What is pregnancy-related pelvic pain?
Pregnancy-related pelvic pain is common and causes pain in the pelvic area during and after pregnancy. It can also cause pain in the hips, legs, and lower back. Often, the pain improves after birth, but sometimes it can last for years. There are various treatment options, including some new ones and some we already recommend.
What are research studies and why are they important?
Before recommending any treatment, it’s important to know that it works, is safe, and is better than existing treatments. Research studies (or clinical trials) help find these things out. These studies can test different treatments, not just medicines. For example, they might test pelvic belts, types of exercise, or special mattresses for people with pregnancy-related pelvic pain.
Why is this study being done?
For research studies to work, people need to join and stay involved. This is called recruitment and retention. If not enough people join or stay in the study, the study might be too small and the results may not be reliable. Sometimes, studies can’t even go ahead.
This study is being done to understand why it can be hard to find and keep people in studies about pregnancy-related pelvic pain. We want to find out what stops people from joining and what could make it easier for them to take part.
What would taking part involve?
Taking part means having a one-time conversation with the researcher, Jasmine Darley. This could be over Teams, by phone, or in person if that’s easier for you. The conversation would last about 30–45 minutes. You’d be asked questions like what might make you want to join a research study or what might stop you from joining. We’d also ask what researchers could do to make studies easier and better for you. The conversation would be recorded and I might take some notes while we talk. Afterwards, I’d type out (transcribe) what we said and remove any details that could identify you. Then, I’d delete the recording.
Am I right for this study?
To take part in this study you will need to be:
1. Somebody that currently has pregnancy-related pelvic pain, or has had it in the past.
2. Aged 18 years or older.
3. Living in the U.K.
What are the possible benefits of taking part?
Taking part in this study can help improve care for people with pregnancy-related pelvic pain. You’ll have a chance to share your thoughts and experiences, which could help future researchers design studies that work better for people like you.
Are there any risks to taking part?
There are no known risks to taking part. But talking about pregnancy-related pelvic pain can sometimes be upsetting. If you become upset during the conversation you will be directed to the Pelvic Partnership, who are a charity which can provide you with further support.
Do I have to take part? Can I change my mind?
No, you don’t have to take part—it’s completely voluntary. You can change your mind at any time. You might be asked why, but you don’t have to say. Not taking part, or deciding to stop, won’t affect your medical care or rights in any way.
Will my information be kept confidential?
Yes. Your GP and healthcare team won’t be told about your involvement. No personal information will be accessed unless you share it yourself. Anything you tell us will be kept confidential, and any quotes used in reports will be made anonymous.
What will happen to my data?
It is important that you understand what happens with any personal information you may give us and the details of the conversation we have (‘your data’).
The records in this study will be kept as confidential as possible. Only the researchers on this study and the monitoring or audit team approved by the university will have access to any of the files, recordings or transcripts. Your data will be anonymised; your name will not be used in any reports or publications resulting from the study. Any personal information, such as your name or anything that could identify who you are, will be stored separately to any other files in a password protected file. Any hard copies or research information such as consent forms or interview recordings will be securely destroyed after being transcribed and uploaded digitally. All information will be stored on the secure University of Plymouth OneDrive and only accessed using password-protected personal computers.
The University of Plymouth is the sponsor for this study based in the United Kingdom. We will use information from you to undertake this study and act as the ‘data controller’. This means that we are responsible for looking after your information and using it properly. The University of Plymouth will keep identifiable information about you for ten years after the study concludes. Your rights to access, change or move your information are limited, as we need to manage your data in specific ways for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. We will use the minimum personally identifiable information to safeguard your rights.
For more information regarding data confidentiality, you can access the research participant privacy notice for Plymouth University:
https://www.plymouth.ac.uk/research/governance/research-participant-privacy-notice
What happens after the study?
After the study finishes, I’ll let you know the results and how they might be useful, unless you’d rather not be contacted. The findings will also be shared in ways like research papers, conference talks, or through websites (such as the University of Plymouth or relevant charities).
What if I have a question or complaint?
If you have any questions regarding this study, please get in touch with the lead researcher (Jasmine Darley, jasmine.darley@plymouth.ac.uk) or supervisor (Jenny Freeman, jenny.freeman@plymouth.ac.uk).
If you have any concerns or complaints about this study’s ethical conduct, please contact the Research Administrator, Faculty of Health Ethics and Integrity Committee, University of Plymouth, Level 2 Marine Building, Drake Circus, Plymouth, Devon, PL4 8AA Email: Research.Ethics@plymouth.ac.uk
The University of Plymouth Research Ethics Policy can be found here: https://www.plymouth.ac.uk/uploads/production/document/path/12/12337/General_Research_Ethics_Policy__final_draft_V1.0_Oct19.pdf
The University of Plymouth Research Data Policy can be found here: https://www.plymouth.ac.uk/uploads/production/document/path/6/6913/Research_Data_Policy.pdf
The University of Plymouth Code of Good Research Practice can be found here: https://www.plymouth.ac.uk/uploads/production/document/path/12/12338/Code_of_Good_Research_Practice.pdf