Study Title: Exploring the effects of Pain on Cognition.
Researcher: Sophia Nematollahi
I would like to invite you to take part in a research study that is being conducted as part of my Master’s degree in Health Psychology. Before you decide if you would like to consider taking part, we would like you to understand the focus of the research and what it would involve for you. If you have any questions about the research after reading the following information, please contact me at the email address provided at the end of this document as I would be happy to discuss the study with you and answer any questions you have or clarify anything as needed.
What is the purpose of the research? This research is being conducted as part of my Master’s degree in Health Psychology. The focus of the study is to examine the effects of pain on cognition. It is hoped that the findings of the study will contribute to informing potential interventions to reduce the potency of cognitive factors on individuals suffering from pain. The research is being supervised by Dr Daniel Gaffiero and Paul Staples who are experienced and highly qualified academics at the University.
Why have I been invited to participate? We are seeking participants for our study on endometriosis, and invite women who have a medical diagnosis of endometriosis. We welcome women currently healthy with no medical conditions (healthy/pain-free) to also contribute to our research.
Do I have to take part? It is entirely your decision whether you agree to take part in the research or not. Participation in the research is entirely voluntary, you do not have to give a reason if you decide not to take part and your decision will be respected. If after reading this information sheet/page you decide not to take part, close the window/exit the survey.
If you do decide to take part, you will be asked to give your consent to confirm you have understood what taking part involves (described below) and how the information you provide (data supplied) will be used and your rights as a participant (data subject).
To take part in the study you will not need to give your name or provide a signature. Instead, you will be asked to generate a unique ID code that is personal to you. You will also be asked to provide some basic demographic information relating to age, sex, gender, ethnicity. This information helps us to understand who has taken part in the research overall and to assess the relevance of the findings. We routinely ask about age, sex, gender, and ethnicity as these have potentially important influences on health and health-related experiences and outcomes.
What will happen to me if I take part? After completing the consent information and demographic questions, you will be asked to take part in an ambiguous scenarios task which will involve you thinking of a word or words to complete an incomplete sentence. Following this, you will then be presented with a questionnaire to measure your recent pain experiences over the past month. Next, you will be asked to complete a pelvic pain questionnaire. Finally, you will be presented with a short task which will involve you thinking about your answers to the ambiguous scenarios task. The questionnaires will take no more no more than 30 minutes to complete. There will be no information obtained or published that might be used to identify you. There are no correct or incorrect answers to these questions, so please answer honestly.
What will happen if I change my mind? If you change your mind before completing the study, you can contact researcher and/or supervisor to withdraw your data from a study. You can also withdraw any data you have provided for up to 2-weeks after having completed the study. You do not need to provide a reason for changing your mind or wanting to withdraw your data.
What are the possible disadvantages and risks of taking part? Please be assured that you do not have to answer any questions/talk about anything that you find too uncomfortable and can move on to another question or decide to stop at any point during the study. In addition, in case participants experience any issues of a psychological nature, signposting to relevant support organisations will be provided in the debrief.
What are the possible benefits of taking part? There are no immediate personal benefits of taking part, although many participants find taking part in research an interesting and rewarding experience. In addition, the findings of this research may help to develop our understanding of informing potential interventions to reduce the potency of cognitive biases
What will happen to the results of the research? The findings of this research will be prepared for assessment in the format of a journal article manuscript and an academic poster. It is also hoped that the findings may be presented at relevant conferences or published in an academic journal so that other academics and clinicians can learn from the research. Individual participants will not be identified in any assessments or publications.
Please read the following information carefully as it outlines the use of your data and your rights. As a legal statement it includes some odd terms such as “data subject” which refers to you as a participant in the research. If any of the information is unclear, please do not hesitate to contact the student researcher or the data protection officer.
Privacy Notice If you agree to take part in this research project the information that you supply will be recorded and processed in line with the UK GDPR / Data Protection Act 2018 / EU GDPR. Data collected will be used by the student researcher as part of an empirical research project that contributes to their Master’s degree in Health Psychology. The University of Derby is the data controller. Anonymised/Pseudonymised data from this project may be used in future publications. We retain the data for a minimum period of 7 years after such time it will be securely destroyed. Data will not be retained for longer than is necessary.
As part of our research, we would like to ask questions that are considered special category data. Our lawful basis for processing this data are: Article 6 legitimate interest and Article 9 your explicit consent.
As a data subject you can request withdrawal of consent within 2-weeks of providing your data by contacting Sophia Nematollahi. After this period data are anonymised and we will be unable to extract your individual data.
Our Data Protection Officer (DPO) is James Fussell on 01332 591954. Alternatively, you can email gdpr@derby.ac.uk. Further information on how we handle your information and details of our DPO can be found on our website: https://www.derby.ac.uk/its/datagov/privnotice
Additional Information The supervisors of this project, who also has access to the data, are highly qualified and experienced and have been very careful to discuss with the student the necessary processes to ensure the security of your data. An Ethics review has been completed on behalf of the College of Health, Psychology and Social Care Research Ethics Committee by two independent reviewers.
We are obliged to: • Not seek more information from you than what is essential and necessary for this research; • Make sure that you are not identified by using ID codes or minimise identification through the use of pseudonyms [delete as appropriate]; • Use your anonymised / pseudonymised data for the purposes of this study and for any relevant publications that arise from it; • Store data safely in password-protected databases to which only the named researchers have access.
Further information about the project can be obtained from the research student Sophia Nematollahi or if you have any concerns about the conduct of this research you can contact their research supervisor Dr Daniel Gaffiero, University of Derby, Kedleston Road, Derby, DE22 1GB.
Next steps and contact details: Thank you for taking the time to read this information and for considering participation in the research. If you agree to take part in the study, please complete the consent information on the next page.
