BEACON Paediatric breakthrough pain assessment V1.0

• Research type

  Research Study

• Full title

  Development and validation of a paediatric breakthrough pain assessment tool

• IRAS ID

  315969

• Contact name

  Christina Liossi

• Contact email

  c.liossi@soton.ac.uk

• Sponsor organisation

  The University of Southampton

• Duration of Study in the UK

  1 years, 0 months, 30 days

• Research summary

  The aim of this study is to develop a reliable, validated, multidimensional questionnaire to assess breakthrough pain in 3-months-25-year-olds. Two versions of the questionnaire will be developed: a self-report form and a form for caregivers/healthcare professionals (for pre- or non-verbal children).

  This is a mixed-methods study comprising three separate studies.
  We will develop a first draft (alpha) version of the paediatric BTP questionnaire using standard, approved methodology. In the first study (Study 1), we will carry out interviews with children and young people (CYP) with life-limiting or life-threatening conditions (LLCs or LTCs) and their caregivers to explore their experiences of BTP. Using the findings, we will modify the questionnaire if needed, to make sure their experiences are represented within it.

  Next, we will develop the second draft of the questionnaire (the beta version) and ask the steering group and additional pain experts for feedback. We will modify the questionnaire again following this. For Study 2, we will conduct cognitive interviews with CYP with LLCs or LTCs, their caregivers, and healthcare professionals. We will ask participants to complete the questionnaire and 'think aloud' as they do this i.e. to say aloud everything they are thinking as they answer the questions. We will use the findings to check if the questionnaire is easy to understand and to modify it if needed.

  For Study 3, we will check if the final version of the questionnaire can accurately characterise paediatric BTP by asking CYP with LLCs or LTCs, their caregivers, and healthcare professionals to complete it at three time points. The results will be looked at in detail to check the questionnaire accurately assesses BTP.

  The final questionnaire will be used in healthcare settings in England to help improve pain control in 3-month-25-year-olds.

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  24/EM/0255

• Date of REC Opinion

  27 Nov 2024

• REC opinion

  Favourable Opinion