Page 1: PARTICIPANT INFORMATION SHEET (version 2 - 27/09/18)

Title of study: An exploration of factors associated with embodiment of upper limb prostheses.

Name of Researcher: Andrew Hodrien.


1.  Invitation paragraph

Thank you for taking the time to find out more about this research study. To consider if you wish to participate in the research please read the information below detailing why you have been invited, what will be involved, and how the study is being managed. If you wish to find out any further details please contact me on the email address at the bottom.


2.  What is the purpose of the study?

Some prosthesis users report that they experience their prosthetic limb as a part of their body, whilst others do not. This experience is known as 'prosthesis embodiment'. A previous interview study with prosthesis users identified a large range of potential factors which may be associated with upper limb prosthesis embodiment. The current study will aim to further explore ‘embodiment’ in a larger sample of prosthesis users. The information gained is hoped to help us understand what helps people with limb loss to accept their prosthetic limb, which may in the future inform prosthesis design or approaches to rehabilitation.


3.  Why have I been invited to take part?

We are inviting anyone over the age of 18, who has had the experience of using an upper limb prosthesis. 


4.  Do I have to take part?

No, this is a completely voluntary study and it is up to you to decide if you wish to participate once you have read all the information. Please take at least 24 hours to consider your involvement.Taking the time to read all of the information provided about the study will help you come to an informed decision. If you do wish to participate you will be asked to complete a consent form before completing the survey. However, anytime during the study you will be able to withdraw (without giving a reason) if you later decide you no longer wish to be involved.


5.  What will happen to me if I take part?

Once you complete the electronic Consent Form you will be given instructions on how to complete the survey. You will then be asked to complete some background information and details of your limb absence. Following on from these questions, you will be asked about your history of prosthesis use and details of your most worn prosthesis. You will then be invited to comment on whether or not you experience phantom limb sensations. Lastly, you will be asked to complete questions on your feelings towards your prosthesis. At the end you will be asked if you are happy for your data to be included in the study. The survey should take approximately 30-40 minutes to complete.


6.  Expenses and payments?

The research will be entirely voluntary so you will not be paid for your participation in the study.


7.  What are the possible disadvantages and risks of taking part?

We understand that issues around the use of a prosthetic limb could be of a sensitive nature so thinking about this may be difficult for you. However, if any particular question is uncomfortable to think about you do not need to answer it. If you wish to withdraw from the study, you can do so at any time without giving reason. If you wish to withdraw your data after the study is complete, you can email the researcher, providing your participant number generated in the survey (this is a unique ‘receipt number’ provided to you once the survey is complete), and request your data is removed. The final date for removal is 18/02/2019.   


8.  What are the possible benefits of taking part?

We cannot guarantee that you will benefit from taking part in this study, but it is hoped that the knowledge generated will ultimately help to improve how professionals, such as prosthetists and medical doctors, approach upper limb amputee rehabilitation and/or prosthetic design. 


9.  What if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak to the researcher (Andrew Hodrien – Email: a.d.hodrien@edu.salford.ac.uk) who will do their best to answer your questions. If you remain unhappy and wish to complain formally you can do this by contacting the Research Supervisor (Dr Adam Galpin - Telephone: 0161 295 7146). If the matter is still not resolved, please forward your concerns to Professor Susan McAndrew, Chair of the Health Research Ethical Approval Panel, Room MS1.91, Mary Seacole Building, Frederick Road Campus, University of Salford, Salford, M6 6PU, UK. Tel: 0161 295 2778. Email: s.mcandrew@salford.ac.uk.


10.  Will my taking part in the study be kept confidential?

Your identity will be kept confidential by completing the survey anonymously. 


11.  What will happen if I don’t carry on with the study?

If you decide not to carry on with the study you can provide your research code and then your data will be deleted. This can be done up until 18/02/2019 when the data will be written up and analysed.


12.  What will happen to the results of the research study?

The results will be disseminated through the researcher’s PhD thesis, along with publications and/or presentations in academic journal articles and conferences. These outputs will present the grouped results from all participants, and possibly any quotes where you wish to clarify your answer. These will be anonymous so it is unlikely that individual responses will be reported.


13.  Who is organising or sponsoring the research?

The research is being organised by the Centre for Health Sciences Research, University of Salford, Salford, M6 6PU, UK. The research is being conducted as part of a PhD project funded by the University of Salford.


14.  Further information and contact details:  

If you would like to enquire about any additional information please contact Andrew Hodrien at a.d.hodrien@edu.salford.ac.uk  

Supervised by Dr. Adam Galpin. Email: A.J.Galpin@salford.ac.uk. Telephone: 0161 295 7146. Senior Lecturer, School of Health Sciences, L812b Allerton Building, University of Salford, Salford, Manchester, M6 6PU, UK.

 

If you wish to seek support or further information relevant to your circumstances or experiences then I will provide here the contact details of amputee/prosthesis associations and a general support organisation:

The limbless association: http://www.limbless-association.org/ - for general advice.

Amputee Coalition: https://www.amputee-coalition.org/ - for general advice and support information.

Limbpower: http://limbpower.com/ – for general advice or activities.

The British Limbless ex-servicemen's association: https://blesma.org/ - if you have served in the British military.

Samaritans: https://www.samaritans.org/ - for general support.

 

Thank you for taking the time to read about this study and for considering participation.