The REST feasibility trial: sleep and pain in patients undergoing TKR

• Research type

  Research Study

• Full title

  REST: A prospective randomised feasibility study assessing the impact of a tailored sleep intervention in patients undergoing total knee replacement

• IRAS ID

  289761

• Contact name

  Katie Whale

• Contact email

  katie.whale@bristol.ac.uk

• Sponsor organisation

  North Bristol NHS Trust

• ISRCTN Number

  ISRCTN14233189

• Duration of Study in the UK

  1 years, 9 months, 31 days

• Research summary

  The aim of this research is to find out how best to design a randomised trial to test if we can improve sleep before knee replacement surgery and reduce long-term pain.

  Knee replacement is the second most common operation in the UK with over 100,000 performed yearly. Around 20% of patients experience long-term pain after surgery causing problems with knee function, decreased activity, and a negative impact on wellbeing. Additional treatments and appointments needed to address long-term pain come at increased cost to the NHS. People with higher levels of pain before their operation are more likely to have long-term pain afterwards. Sleep has a two-way relationship with pain. Reduced sleep causes increased pain and improvement of sleep has been shown to reduce both immediate and long-term pain in people with joint problems. Our aim is to find out how best to design a larger study to test a pre-operative sleep intervention for improving long-term pain.

  Design and methods
  The key questions this study will address are:
  1. Are patients willing to take part in the study?
  2. Will patients attend the clinic appointment?
  3. Will patients engage in the sleep intervention and adhere to the agreed plan?
  4. Do practitioners deliver the intervention as intended?

  Patients on the surgical waiting list will be recruited and randomised to receive either standard care or the sleep intervention. Patients taking part in the intervention will attend a one-to-one appointment with an healthcare practitioner to assess their sleep issues and needs. They will then be given tailored sleep advice and will be assigned to one of 3 existing sleep interventions:
  • Cognitive-behavioural therapy for insomnia
  • Relaxation
  • Mindfulness

  An interview study with practitioners and patients will explore acceptability of delivering the intervention and the feasibility of a full trial.

  Patient reported data will be collected on:
  • Joint pain
  • Neuropathic pain
  • Sleep quality
  • Mood and well-being

  We will also collect data on:
  • Recruitment rate
  • Adherence and engagement with the intervention
  • Health economics

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  20/SW/0189

• Date of REC Opinion

  27 Dec 2020

• REC opinion

  Favourable Opinion