Condition category
Musculoskeletal Diseases
Date applied
20/03/2013
Date assigned
22/04/2013
Last edited
28/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Interpretative Phenomenological Analysis (IPA) is a qualitative research method that aims to explore an individual’s own lived experience of a phenomenon and has been successfully utilised in general chronic pain research. Pain is a significant side effect of spinal cord injury (SCI), particularly after discharge where patients do not have direct access to medicines, doctors or physiotherapy. IPA has not been used to study pain in these types of patients. This study is expected to last one year and aims to understand the experience of pain as a result of a spinal cord injury.

Who can participate?
Participants will be inpatients of at least 6 months and outpatients recruited from the National Spinal Injuries Centre, Stoke Mandeville Hospital (UK) database if they report suffering with chronic pain. They will have no other known chronic health condition that may affect their experience of pain. The lower age limit is 18 years, whilst there is no upper age limit. Both males and females are invited to take part.

What does the study involve?
All participants will have to give an informed written consent. Each participant will be interviewed either in a private room at the hospital or at their own home about their pain using a semi-structured format. This will include non-directive questions that allow the participant to take the lead and tell their own story. Interviews will be tape-recorded, transcribed and analysed using IPA in order to generate themes that are present in each account. These themes will then be further analysed and placed into broader (called superordinate) themes. Superordinate themes will be identified and described, presenting the most important aspects of a patient’s experience of pain. The deeper understanding of the lived experience of pain in SCI will suggest which aspects of the experience are most powerful in aiding or challenging integration into the community. It will also aid the development of SCI-specific pain management programmes.

What are the possible benefits and risks to taking part in this study?
No interventions will take place during this research, therefore there will be no risk of physical harm to participants. Should participants wish to travel to have their interview, any expenses they incur will be reimbursed.
It is possible, however, that talking about the experience of pain may distress some participants. However, part of IPA training involves being aware and monitoring the effect of the interview on the participant. If a participant does become distressed they may give as much or as little information to the interview as they want to. Participants will be allowed to have a friend or family member present during their interview. They will be allowed to halt the interview at any time. They may withdraw from the study and have their data destroyed should they so wish.
As this is a qualitative study, quotes from participants will be used to demonstrate themes in the final report. All participants and anybody they may identify during their interviews will be given pseudonyms in order to protect their identity.
Data will be stored in a password-protected computer database on the psychology department server at The University of Buckingham. All tapes will be kept in locked filing cabinets. Patient identifiers (demographic details) will be stored in the password-protected computer database, but separate from the corresponding data. Dr Katherine Finlay will be the custodian of this information and only those directly involved in the research will have access to this information.

Where is the study run from?
The study has been set up by The University of Buckingham, in collaboration with The National Spinal Injuries Centre, Stoke Mandeville Hospital, Aylesbury (UK).

When is the study starting and how long is it expected to run for?
Data collection is expected to start in May 2013 and end in August 2013. Participants will be enrolled in the study for one year.

Who is funding the study?
This research is funded by an MSc scholarship from The University of Buckingham (UK).

Who is the main contact?
Jasmine Hearn, Principal Investigator, 0900611@buckingham.ac.uk
Katherine Finlay, Chief Investigator, katherine.finlay@buckingham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katherine Finlay

ORCID ID

Contact details

The Psychology Department
The University of Buckingham
Hunter Street
Buckingham
MK18 1EG
United Kingdom
katherine.finlay@buckingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An Interpretative Phenomenological Analysis of the Experience of Chronic Pain in Inpatients and Outpatients with a Spinal Cord Injury

Acronym

Study hypothesis

So far, all of the research on pain in spinal cord injury has been quantitative. The experience of pain, however, is subjective, therefore this study is looking to explore the lived experience of chronic pain in individuals with a spinal cord injury using a qualitative methodology. This is expected to identify themes that suggest the most important aspects of an individual's pain experience. Themes that are prevalent across many individuals may help to develop pain management programmes specific to spinal cord injury.

On 23/08/2013 the anticipated end date was changed from 01/09/2013 to 01/09/2014.
On 28/08/2013 the scientific title was changed from "An Interpretative Phenomenological Analysis of the Experience of Chronic Pain in Outpatients with a Spinal Cord Injury" to "An Interpretative Phenomenological Analysis of the Experience of Chronic Pain in Inpatients and Outpatients with a Spinal Cord Injury".

Ethics approval

Added 28/08/2013: NRES Committee London - Bloomsbury, 14/05/2013, ref: 13/LO/0558

Study design

Single-centre observational study that will use a between-subjects qualitative design

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Spinal cord injury and pain, Musculoskeletal, Neuropathic Pain, General Healthcare

Intervention

Current interventions as of 28/08/2013:

For this research, all SCI patients who have been discharged from Stoke Mandeville Hospital within the last 20 years and inpatients of at least 6 months will be contacted. All will be aged 18 years or older. Of those who respond reporting chronic pain, between eight and twelve participants will be recruited. They will be asked to sign a consent form after reading the participant information sheet and an interview date and time will be arranged at the convenience of the participant. These interviews will be carried out in the participant’s own home or in a private room at Stoke Mandeville Hospital. Participants will take part in interviews lasting a maximum of 2 hours. A semi-structured format will be followed but the participant will take the lead on describing their experiences. The researcher will probe further into any topics raised by the participant that may be of interest to the research. Interviews will be tape-recorded, transcribed word for word and analysed using IPA. Transcripts will be read multiple times in order to gain familiarity before themes are identified among the text. These themes will be grouped into larger themes that suggest what the most important factors are in the experience of chronic pain after SCI.

Previous interventions:

For this research, all SCI patients who have been discharged from Stoke Mandeville Hospital within the last 20 years will be contacted. All will be aged 18 years or older. Of those who respond reporting chronic pain, between eight and twelve participants will be recruited. They will be asked to sign a consent form after reading the participant information sheet and an interview date and time will be arranged at the convenience of the participant. These interviews will be carried out in the participant’s own home or in a private room at Stoke Mandeville Hospital. Participants will take part in interviews lasting a maximum of 2 hours. A semi-structured format will be followed but the participant will take the lead on describing their experiences. The researcher will probe further into any topics raised by the participant that may be of interest to the research. Interviews will be tape-recorded, transcribed word for word and analysed using IPA. Transcripts will be read multiple times in order to gain familiarity before themes are identified among the text. These themes will be grouped into larger themes that suggest what the most important factors are in the experience of chronic pain after SCI.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Superordinate themes identified from transcripts that identify the key aspects of the pain experience in individuals with a spinal cord injury.

Interpretative Phenomenological Analysis will be used in order to find the outcome themes.

Secondary outcome measures

Subordinate themes will provide superordinate themes with detail and content.

Overall trial start date

01/05/2013

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

The inclusion criteria were developed to be relevant to the research question, rather than to be representative of the population, as suggested by Willig, C. (2001). Introducing qualitative research in psychology: Adventures in theory and method. Buckingham: Open University Press.

Current inclusion criteria as of 23/08/2013:

1. Participants with a spinal cord injury must be inpatients of at least 6 months or outpatients of The National Spinal Injuries Center, Stoke Mandeville Hospital, Aylesbury.
2. All participants both male and female must be over 18 years of age and sufferers of chronic pain for 6 months or longer. There is no upper age limit.
3. Due to the fact that in depth interviews will be carried out, sufficient understanding of English must be held by all participants.

Original inclusion criteria:

1. Participants with a spinal cord injury must be outpatients of The National Spinal Injuries Center, Stoke Mandeville Hospital, Aylesbury.
2. All participants both male and female must be over 18 years of age and sufferers of chronic pain for 6 months or longer. There is no upper age limit.
3. Due to the fact that in depth interviews will be carried out, sufficient understanding of English must be held by all participants.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

15

Participant exclusion criteria

1. Participants will not be recruited if they hold any cognitive impairment or mental illness.
2. Participants with articulation difficulties and an insufficient understanding of English will be excluded from this study.
3. Any respondents with any other long term health condition that may affect the experience of pain, or be the cause of chronic pain (as opposed to the spinal injury) will be excluded.

Recruitment start date

01/05/2013

Recruitment end date

01/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Psychology Department
Buckingham
MK18 1EG
United Kingdom

Sponsor information

Organisation

University of Buckingham (UK)

Sponsor details

The Psychology Department
Hunter Street
Buckingham
MK18 1EG
United Kingdom
alan.martin@buckingham.ac.uk

Sponsor type

University/education

Website

http://www.buckingham.ac.uk

Funders

Funder type

University/education

Funder name

University of Buckingham (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes