Ethics Reference Number: 305643
PARTICIPANT INFORMATION SHEET
Study Title:
To what extent are self-reported cognitive symptoms associated with self-management of chronic pain?
Why have I been given this information sheet?
Thank you for taking the time to look at this information about the research we are doing. We are inviting you to take part in our research. Please have a good look at the following information and carefully think if you would like to take part. It is completely up to you whether or not you take part and taking part or not will not affect your care within your NHS trust.
Why are we doing this research?
We aim to increase understanding about how cognitive symptoms (such as concentration, attention and memory) are associated with the ability to manage chronic pain. We are also interested in whether low mood and the way we think about our pain are associated with the ability to manage chronic pain. We think that learning more about these relationships will help services to understand how to better support people to manage their pain.
Why have I been asked to take part?
We are asking if you want to take part because you have told someone that you are interested in taking part in research. We are looking for people who have a diagnosis of chronic pain and who have been referred to a Pain Management clinic. It doesn’t matter what type of chronic pain you have been diagnosed with. You must between the age of 18-65 take part in the study and speak English.
Who is organising and funding the research?
The lead researcher is Georgina Forden, who is a Trainee Clinical Psychologist from the University of East Anglia (UEA) employed by Cambridge and Peterborough NHS Foundation Trust, this research will contribute towards her doctoral thesis.
The research team also includes, Dr Catherine Ford, a Clinical Neuropsychologist and Clinical Lecturer at the UEA; Dr Sarah Fish, a Clinical Psychologist working at Norfolk and Suffolk Foundation Trust (NSFT) and a Clinical Lecturer at the UEA; and Dr Sarah Ronaghan, a Consultant Clinical Psychologist in Chronic Pain Service at Stamford and Rutland Hospital.
Who has checked the study?
All research by UEA in the NHS is looked at by another group of people, called the Health Research Authority. This is a national organisation that makes sure that all research that is done in the NHS is of good quality, abides by all the relevant laws and guidance, and is safe for everyone involved it in it. They have said that this research meets their very strict criteria and is safe to do. We have also been given permission by you healthcare provider to conduct the research in their organisation.
Do I have to take part?
No. It is entirely up to you. There is absolutely no pressure to take part and everyone involved will fully respect all decisions you make. There will be no changes made to any treatment, care or rights should you decide to take part or not. You do not have to give anyone a reason for not taking part if you do not want to. You can also change your mind at any point in the study.
What will happen if I take part?
If you decide you do want to take part you will be asked to sign a consent form. You will have been given the consent form by staff at your chronic pain clinic or you can complete it online. You will be asked to post the form using a prepaid registered envelope or sign a consent form online, to say you are happy to take part and that you have had the study explained to you.
Once you are happy with that you will be given a set of questionnaires to complete. These will be given to you by your chronic pain team in either a paper format, or you can complete them online, or you can chose to do them over the phone with Georgina Forden (the lead researcher).
Your safety will be the most important thing so we will only the research team will have access to the questionnaires you complete. The answers you give to the questionnaires will be stored electronically on an encrypted device.
Once that is done your part in the research will be finished. You will be contacted after the study is written up to provide you with a copy of the results and offered the opportunity to discuss it by telephone, if that is your wish.
Where and when will the study be done?
The questionnaires will be given to you in either a paper or online format so that you can do them at home or in a private place of your choosing. If you have any problems accessing or completing the questionnaires then you can do them over the telephone with Georgina Forden (lead researcher).
How much of my time will it take?
We estimate that the questionnaires may take up to 30 minutes to complete in total. They do not need to be completed in one go but we ask that you try to complete them within the same day.
What information will be collected and how will it be used?
We will be collecting different types of information from you to help us with the project.
- People will use this information to do the research or to check your records to make sure that the research is being done properly.
- We will collect your name and contact details initially, as well of the name of the lead professional involved with your care and you GP. This is so we can contact you throughout the study. When the study is finished these details will be deleted.
- Your age, gender, ethnicity, employment status, sexuality and education and whether or not you have a disability, will be collected to help us understand some of the differences between participants, however, it is your choice whether you tell us this.
- People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.
- We will keep all information about you safe and secure.
- Once we have finished the study we will keep some of the data so that we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
- To find out more about how your information is used at the University of East Anglia please contact the data protection officer: Ellen Patterson at dataprotection@uea.ac.uk or 01603 59243
What are your choices about how your information is used?
- You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
- We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
Will anyone else know I’m doing this?
The people in our research team and your GP will be aware you are taking part. We ask this so that they are aware of your involvement in the study and to help if you require any additional support when taking part in the study. We will only disclose what the study is investigating and not your answers to the questionnaires.
We will also let your GP know if, by answering the questionnaires, you indicate you have symptoms of low mood or anxiety. We will inform your GP so that they are able to offer you some support with this. Whilst we aim to maintain your confidentially in the study, we may have to break confidentiality if you tell us something that suggests that you or someone else is at significant risk of harm. If you disclose something to us in the study which indicates, that you or others are at risk of harm, then we have a duty of care to inform your GP and other services of this. This is so that we can keep you and others safe. In the unlikely event that happens, we will do everything we can to try to discuss this with you first.
All information collected during the study will be treated as strictly confidential. The research team follow the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018. All paper information, like paper consent forms, will be kept in a locked cabinet and locked office at the UEA. Any information about you will be kept on a secure online drive called OneDrive. We will change your name on the all the stored information as soon as reasonably possible and to make sure you cannot be identified. Only researchers at the University will be able to look at your personal information collected for the study and all identifiable information will be deleted once the study is complete in August 2023. Any anonymised data will be stored for up to 10 years and deleted after this time.
When the research is written up and published all your data will be unidentifiable so that people reading will not know who you are. We may also share the anonymised data collected in the study with other researchers who are interested in this area, from our organisation and other organisations. These other organisations may be universities, NHS organisation’s or companies involved in health and care research in this country or abroad. This information will not identify you and will only be used for the purpose of health and care research.
Is there anything I should be worried about if I take part?
Your rights and wellbeing are our top priority and the research team will make sure that everyone involved in the study is kept safe, especially in light of the COVID-19 pandemic. For this reason, we will offer all the research to be completed online to all participants to make sure there is no risk of infection though close contact with the researcher.
During the contact with the study you will be asked whether you want to take part in the in the study. Should you feel upset or distressed in any way then please let us know and you will be asked if you wish to continue and we will support you with whatever you decide to do. The researcher you will be speaking with is trained and experienced in providing support to people who are experiencing distress. They can also help you seek further support from your healthcare provider or other mental health support agencies.
You will need to take some time to take part in the study. We will endeavour to keep this time to a minimum and hope that the benefits of taking part will outweigh this cost.
Will taking part help me?
This study is explicitly focused on understanding how people experience Chronic Pain and the impact it has on their ability to manage the condition, this will help to guide services on how to work more effectively with people with Chronic Pain. However, there are no predicted benefits of taking part in the research, apart from a potential benefit of helping to inform the services you use.
By taking part you will be entered in a draw to receive a £20 Amazon voucher for your time. If you have won the draw you will be contacted after the study is completed.
It is important to know that this is a research study, not a form of treatment for mental health problems. Therefore, if you are worried about your mental health or wellbeing, please speak to your GP. Or you can contact either:
Samaritans – 24/7 confidential emotional support
Tel: 116 123
Norwich Mind Support Line
Tel: 0808 802 0288
First Response – 24/7 helpline offering immediate advice and support for people in Suffolk and Norfolk with mental health difficulties- call 0808 196 3494
Norfolk and Suffolk Crisis line numbers, for NSFT service users:
Suffolk (except Great Yarmouth and Waveney) - call 0300 123 1334
Norfolk (except Great Yarmouth and Waveney) - call 0300 790 0371
Great Yarmouth and Waveney - call 01493 337958
The First Response Service (FRS- for those who live in Cambridgeshire)- call 111 option 2
What happens when the study finishes?
Once all the questionnaires have been collected the data will be typed up and analysed by the research team at the UEA. These findings will be written up and published.
What happens to the results of the research?
We plan to look at the information gathered from the study and share the results in presentations, publications and using social or national media. When we share the results, no one will be able to know you took part as we will make sure it is all anonymous and unidentifiable.
You will be asked if you want a copy of findings once the project is finished and ready to be published and if you do this will be sent out to you by post or email. You will also be able to discuss it with the lead researcher by phone if you wish.
Following UEA guidance, information collected during the study will be kept safely for at least 10 years following any publications before being destroyed.
What if there is a problem or something goes wrong?
If you are worried about anything relating to the research, please speak to someone from the research team and we will try our best to help you.
If you have a complaint about the research or researchers, please contact Professor Niall Broomfield, Director of the UEA ClinPsyD Programme (N.Broomfield@uea.ac.uk or Tel: 01603 593 061). Professor Niall Broomfield is separate from this research study so you can speak to him confidently.
How can I find out more?
You can contact the research team:
Georgina Forden, Trainee Clinical Psychologist
Email: g.forden@uea.ac.uk Tel: 07785395689
Catherine Ford, Clinical Psychologist and Clinical Associate Professor
Email: Catherine.ford@uea.ac.uk Tel: 01603 456 161
You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/
What happens next?
Thank you for taking your time to read this information sheet. Please get in touch if you have any questions or want more information.
After giving you this information sheet, you will hear nothing from us for at least 72 hours (3 days). This is to make sure that you have time to read the information through and consider fully if you would like to take part. You will then be contacted by Georgina Forden (the lead researcher) by telephone to discuss it further and to see if you want to take part.
If you decide that you would rather not take part in this study, you do not need to give a reason and no further contact will be made.
Thank you very much for considering this research,
The Research Team