Participant Information Sheet

Study Title: Exploring the relationship between prosthesis use and thoughts about amputation

My name is Nicolas Burden and I am conducting this study as part of my doctoral programme in Clinical Psychology at Lancaster University, Lancaster, United Kingdom.

What is the study about?

The purpose of this study is to explore the relationship between thoughts or feelings about amputation and the extent to which adults who have an amputated limb use a prosthesis or artificial limb.

Why would you like me to take part?

We are interesting in gathering information from individuals who have an amputated limb and who have access to a prosthetic limb. If you fit the following criteria for inclusion in the study, then we would be very grateful if you could complete our survey.

Inclusion criteria

  • If you have an acquired amputation (limb removed due to complications with disease or an accident)
  • If you have the availability of a prosthetic limb
  • If you are 16 years of age or above
In some circumstances, other factors might change the nature of your prosthesis use. You should not take part in the survey if;
  • Your use of a prosthetic limb is restricted for any reason outside of your own choice (e.g., medical recommendation)
  • You use a prosthetic limb to aid with a congenital limb anomaly (the limb was absent or differently developed from birth)

Do I have to take part?

No. It's completely up to you to decide whether or not you take part. If you do chose to take part, you can still change your mind at any point up until completion of the survey. However, once you have completed the survey, it will not be possible for us to take out your data.

What will I be asked to do if I take part?

If you decide you would like to take part, you will be asked to fill in a series of questionnaires including demographic information and questions about your thoughts, feelings or actions that we think might be related to prosthesis use. The length of time to complete the survey will vary from person to person, but it should take no longer than 30 (thirty) minutes.

Note: If you would prefer to complete a paper copy of the study, please contact the principal researcher, Nicolas Burden, on n.burden@lancaster.ac.uk stating that you would like a paper copy of the study materials and providing a mailing address. A copy of the study materials will be sent to you along with a stamped and addressed envelope for you to return the materials once they are completed.

Will my data be confidential?

The information you provide is completely confidential. The data collected for this study will be stored securely and only the researchers conducting this study will have access to the information. The information you provide will be stored on a secure network at Lancaster University and only the members of the research team will be able to access the information. Electronic information will be stored for ten years and at the end of this period deleted.

[There are some limits to confidentiality: due to the nature of the survey, it is unlikely that the research team will be able to intervene if information gathered raises concern for the welfare of yourself or other people. However, if information shared via email (e.g., when requesting additional information) raises concern for the welfare of yourself or other people (i.e. if you indicate that harm may be caused to yourself or others) this information may be forwarded to a health or support agency (e.g. a general practitioner). If you feel that you could benefit from help for your emotional or physical wellbeing, it is advised that you contact your local health or support services].

What will happen to my data?

Your data will be pooled with data from other participants. The data will then be analysed and reported to Lancaster University as a doctoral thesis. The results may also be written up for publication in an academic or professional journal, and for written or verbal presentation to organisations involved with amputation or prosthesis, conferences and health or research teams. A summary of the results from this study will be made available to participants on request, after the study has completed. It is expected that summaries will be available from July 2016. If you would like a summary of the results, please contact the principal researcher, Nicolas Burden, by email; n.burden@lancaster.ac.uk

Are there any risks?

There are no risks anticipated with participating in this study. However, if you experience any distress following participation you may wish to exit the survey and/or contact support from a health agency or helpline available in your area.

Sources of support

If you feel you need support with any of the issues covered, please contact your doctor who will be able to help further and refer you to the appropriate service if necessary. Alternatively, please visit the below websites, with international coverage, where you will find details for how you can find support.

Befrienders Worldwide [http://www.befrienders.org]

- "Providing emotional support to prevent suicide worldwide. We listen to and help people without judging them".

The Amputee Coalition [http://www.amputee-coalition.org]

- [We aim] "to reach out to and empower people".

Are there any benefits to taking part?

We hope that you will find the survey interesting and that the study will lead to a better understanding of prosthesis use that will aid healthcare provision. However, there are no direct gains to taking part in the study.

Who has reviewed the project?

This study has been reviewed by the Faculty of Health and Medicine Research Ethics Committee, and approved by the University Research Ethics Committee at Lancaster University.

Where can I obtain further information about the study if I need it?

If you have any questions about the study, please contact the principal researcher: Nicolas Burden, by email;
n.burden@lancaster.ac.uk

Alternatively you can contact Dr Jane Simpson, Research Director for Clinical Psychology at Lancaster University;
j.simpson2@lancaster.ac.uk

Complaints

If you wish to make a complaint or raise concerns about any aspect of this study and do not want to speak to the researcher, you can contact:
Professor Bruce Hollingsworth Tel: (01524) 594154
Professor, Head of Department; Email: b.hollingsworth@lancaster.ac.uk
Division of Health Research
Lancaster University
Lancaster
LA1 4YG

Thank you for taking the time to read this information. Please ensure that you take adequate time to consider your participation before following the link below to the survey.

https://lancasteruni.qualtrics.com/SE/?SID=SV_cNM2DRamqcFYkq9