Recruiting and retaining people with pregnancy-related pelvic girdle pain to research studies
Participant information sheet
You are invited to contribute to a research study focused on understanding the challenges of recruiting and retaining women with pregnancy-related pelvic girdle pain (PPGP) in clinical research. Before deciding on your involvement, please review this information, which outlines the study’s purpose and what participation entails.
What is pregnancy-related pelvic girdle pain?
Pregnancy-related pelvic girdle pain is a prevalent musculoskeletal condition that causes discomfort in the pelvic region during pregnancy and can persist postpartum. Symptoms often extend to the hips, legs, and lower back. While many women experience symptom resolution after childbirth, for some, pain and functional limitations may persist for years. Various therapeutic interventions, both established and emerging, are employed to manage PPGP.
Why is this study important?
Robust clinical research relies on effective participant recruitment and retention. Inadequate recruitment or high attrition can limit study validity and generalisability, and in some cases, prevent studies from proceeding at all. This project aims to investigate the barriers and facilitators to recruiting and retaining participants in research on PPGP.
Study objectives
The study seeks to understand:
1. Why women with PPGP may choose to participate—or not—in research studies.
2. What barriers hinder recruitment and retention.
3. What approaches might facilitate engagement in future research.
What does participation involve?
Participation involves a single, 30–45 minute semi-structured interview with the researcher, Jasmine Darley. This can be conducted via Microsoft Teams, telephone, or in person, depending on your preference. The interview will focus on your experiences and perspectives regarding participant engagement in research on PPGP.
Interviews will be audio recorded and transcribed verbatim. Identifiable information will be removed during transcription, and recordings will be deleted once transcription is complete.
Who can participate?
You are eligible to take part if you:
1. Are involved in clinical care or research concerning PPGP.
2. Are aged 18 years or older.
3. Are based in the United Kingdom.
Benefits of participation
Your contribution will provide valuable insights that may help optimise future research design and delivery, ultimately improving clinical practice and outcomes for women with PPGP.
Risks and considerations
There are no known risks associated with participation. If you have any concerns about participating, please do not hesitate to get in touch to discuss further.
Voluntary participation and right to withdraw
Participation is entirely voluntary, and you may withdraw at any time without needing to provide a reason. Your decision will not impact your professional standing or any relationships with research teams or academic institutions.
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?
Confidentiality and data handling
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
Results and dissemination
At the conclusion of the study, you will be informed of the findings and their potential implications for clinical practice and research, unless you indicate otherwise. Results will also be disseminated through academic publications, conference presentations, and relevant organisational platforms.
Contact information
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