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Open Access 01-12-2022 | Knee-TEP | Research

Development of a novel intervention to improve sleep and pain in patients undergoing total knee replacement

Authors: K. Whale, R. Gooberman-Hill

Published in: Trials | Issue 1/2022

Abstract

Background

Up to 20% of patients experience long-term pain and dissatisfaction after total knee replacement, with a negative impact on their quality of life. New approaches are needed to reduce the proportion of people to go on to experience chronic post-surgical pain. Sleep and pain are bidirectionally linked with poor sleep linked to greater pain. Interventions to improve sleep among people undergoing knee replacement offer a promising avenue. Health beliefs and barriers to engagement were explored using behaviour change theory. This study followed stages 1–4 of the Medical Research Council’s guidance for complex intervention development to develop a novel intervention aimed at improving sleep in pre-operative knee replacement patients.

Methods

Pre-operative focus groups and post-operative telephone interviews were conducted with knee replacement patients. Before surgery, focus groups explored sleep experiences and views about existing sleep interventions (cognitive behavioural therapy for insomnia, exercise, relaxation, mindfulness, sleep hygiene) and barriers to engagement. After surgery, telephone interviews explored any changes in sleep and views about intervention appropriateness. Data were audio-recorded, transcribed, anonymised, and analysed using framework analysis.

Results

Overall, 23 patients took part, 17 patients attended pre-operative focus groups, seven took part in a post-operative telephone interview, and one took part in a focus group and interview. Key sleep issues identified were problems getting to sleep, frequent waking during the night, and problems getting back to sleep after night waking. The main reason for these issues was knee pain and discomfort and a busy mind. Participants felt that the sleep interventions were generally acceptable with no general preference for one intervention over the others. Views of delivery mode varied in relation to digital move and group or one-to-one approaches.

Conclusion

Existing sleep interventions were found to be acceptable to knee replacement patients. Key barriers to engagement related to participants’ health beliefs. Addressing beliefs about the relationship between sleep and pain and enhancing understanding of the bidirectional/cyclical relationship could benefit engagement and motivation. Individuals may also require support to break the fear and avoidance cycle of pain and coping. A future intervention should ensure that patients’ preferences for sleep interventions and delivery mode can be accommodated in a real-world context.

Registry NJ. NJR 17th Annual Report 2020 2020.

Baker PN, van der Meulen JH, Lewsey J, Gregg PJ. Role of pain and function in determining patient satisfaction after total knee replacement. J Bone Joint Surg Br. 2007;89(7):893–900.PubMedCrossRef

Gandhi R, Davey JR, Mahomed NN. Predicting patient dissatisfaction following joint replacement surgery. J Rheumatol. 2008;35(12):2415–8.PubMedCrossRef

Kim TK, Chang CB, Kang YG, Kim SJ, Seong SC. Causes and predictors of patient's dissatisfaction after uncomplicated total knee arthroplasty. J Arthroplast. 2009;24(2):263–71.CrossRef

Robertsson O, Dunbar M, Pehrsson T, Knutson K, Lidgren L. Patient satisfaction after knee arthroplasty: a report on 27,372 knees operated on between 1981 and 1995 in Sweden. Acta Orthop Scand. 2000;71(3):262–7.PubMedCrossRef

Kassam AM, Dieppe P, Toms AD. An analysis of time and money spent on investigating painful total knee replacements. Br J Med Practitioners. 2012;5(3):a526.

Wylde V, Hewlett S, Learmonth ID, Dieppe P. Persistent pain after joint replacement: prevalence, sensory qualities, and postoperative determinants. Pain. 2011;152(3):566–72.PubMedCrossRef

Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015;114(4):551–61.PubMedCrossRef

Sayers A, Wylde V, Lenguerrand E, Beswick AD, Gooberman-Hill R, Pyke M, et al. Rest pain and movement-evoked pain as unique constructs in hip and knee replacements. Arthritis Care Res (Hoboken). 2016;68(2):237–45.CrossRef

10.

Yang MMH, Hartley RL, Leung AA, Ronksley PE, Jette N, Casha S, et al. Preoperative predictors of poor acute postoperative pain control: a systematic review and meta-analysis. BMJ Open. 2019;9(4):e025091.PubMedPubMedCentralCrossRef

11.

Boardman HF, Thomas E, Millson DS, Croft PR. The natural history of headache: predictors of onset and recovery. Cephalalgia. 2006;26(9):1080–8.PubMedCrossRef

12.

Finan PH, Goodin BR, Smith MT. The association of sleep and pain: an update and a path forward. J Pain. 2013;14(12):1539–52.PubMedPubMedCentralCrossRef

13.

Lewandowski AS, Palermo TM, De la Motte S, Fu R. Temporal daily associations between pain and sleep in adolescents with chronic pain versus healthy adolescents. Pain. 2010;151(1):220–5.PubMedPubMedCentralCrossRef

14.

Morin CM, LeBlanc M, Daley M, Gregoire JP, Merette C. Epidemiology of insomnia: prevalence, self-help treatments, consultations, and determinants of help-seeking behaviors. Sleep Med. 2006;7(2):123–30.PubMedCrossRef

15.

Orbach-Zinger S, Fireman S, Ben-Haroush A, Karoush T, Klein Z, Mazarib N, et al. Preoperative sleep quality predicts postoperative pain after planned caesarean delivery. Eur J Pain. 2017;21(5):787–94.PubMedCrossRef

16.

Smith MT, Haythornthwaite JA. How do sleep disturbance and chronic pain inter-relate? Insights from the longitudinal and cognitive-behavioral clinical trials literature. Sleep Med Rev. 2004;8(2):119–32.PubMedCrossRef

17.

Frey DJ, Fleshner M, Wright KP Jr. The effects of 40 hours of total sleep deprivation on inflammatory markers in healthy young adults. Brain Behav Immun. 2007;21(8):1050–7.PubMedCrossRef

18.

Haack M, Scott-Sutherland J, Santangelo G, Simpson NS, Sethna N, Mullington JM. Pain sensitivity and modulation in primary insomnia. Eur J Pain. 2012;16(4):522–33.PubMedPubMedCentralCrossRef

19.

Lautenbacher S, Kundermann B, Krieg JC. Sleep deprivation and pain perception. Sleep Med Rev. 2006;10(5):357–69.PubMedCrossRef

20.

Wright KP Jr, Drake AL, Frey DJ, Fleshner M, Desouza CA, Gronfier C, et al. Influence of sleep deprivation and circadian misalignment on cortisol, inflammatory markers, and cytokine balance. Brain Behav Immun. 2015;47:24–34.PubMedPubMedCentralCrossRef

21.

Smith MT, Edwards RR, McCann UD, Haythornthwaite JA. The Effects of Sleep Deprivation on Pain Inhibition and Spontaneous Pain in Women. Sleep. 2007;30(4):494–505.PubMedCrossRef

22.

Haack M, Sanchez E, Mullington JM. Elevated inflammatory markers in response to prolonged sleep restriction are associated with increased pain experience in healthy volunteers. Sleep. 2007;30(9):1145–52.PubMedPubMedCentralCrossRef

23.

Haack M, Mullington JM. Sustained sleep restriction reduces emotional and physical well-being. Pain. 2005;119(1-3):56–64.PubMedCrossRef

24.

Theadom A, Cropley M, Humphrey KL. Exploring the role of sleep and coping in quality of life in fibromyalgia. J Psychosom Res. 2007;62(2):145–51.PubMedCrossRef

25.

Nitter AK, Pripp AH, Forseth KO. Are sleep problems and non-specific health complaints risk factors for chronic pain? A prospective population-based study with 17 year follow-up. Scand J Pain. 2012;3(4):210–7.PubMedCrossRef

26.

Mamie C, Bernstein M, Morabia A, Klopfenstein CE, Sloutskis D, Forster A. Are there reliable predictors of postoperative pain? Acta Anaesthesiol Scand. 2004;48(2):234–42.PubMedCrossRef

27.

Luo ZY, Li LL, Wang D, Wang HY, Pei FX, Zhou ZK. Preoperative sleep quality affects postoperative pain and function after total joint arthroplasty: a prospective cohort study. J Orthop Surg Res. 2019;14(1):378.PubMedPubMedCentralCrossRef

28.

Smith TJ, Wilson MA, Karl JP, Orr J, Smith CD, Cooper AD, et al. Impact of sleep restriction on local immune response and skin barrier restoration with and without "multinutrient" nutrition intervention. J Appl Physiol (1985). 2018;124(1):190–200.CrossRef

29.

Leigh TJ, Hindmarch I, Bird HA, Wright V. Comparison of sleep in osteoarthritic patients and age and sex matched healthy controls. Ann Rheum Dis. 1988;47:40–2.PubMedPubMedCentralCrossRef

30.

Pickering ME, Chapurlat R, Kocher L, Peter-Derex L. Sleep Disturbances and Osteoarthritis. Pain Pract. 2016;16(2):237–44.PubMedCrossRef

31.

Smith MT, Quartana PJ, Okonkwo RM, Nasir A. Mechanisms by which sleep disturbance contributes to osteoarthritis pain: a conceptual model. Curr Pain Headache Rep. 2009;13:447–54.PubMedCrossRef

32.

Wylde V, Rooker J, Halliday L, Blom A. Acute postoperative pain at rest after hip and knee arthroplasty: severity, sensory qualities and impact on sleep. Orthop Traumatol Surg Res. 2011;97(2):139–44.PubMedCrossRef

33.

Cremeans-Smith JK, Millington K, Sledjeski E, Greene K, Delahanty DL. Sleep disruptions mediate the relationship between early postoperative pain and later functioning following total knee replacement surgery. J Behav Med. 2006;29(2):215–22.PubMedCrossRef

34.

Krenk L, Jennum P, Kehlet H. Sleep disturbances after fast-track hip and knee arthroplasty. Br J Anaesth. 2012;109(5):769–75.PubMedCrossRef

35.

Gong L, Wang Z, Fan D. Sleep quality effects recovery after total knee arthroplasty (TKA)--a randomized, double-blind, controlled study. J Arthroplast. 2015;30(11):1897–901.CrossRef

36.

Carskadon MA, Dement WC. Monitoring and staging human sleep. In: Kryger M, Roth T, Dement D, editors. Principles and practices of sleep medicine. 5th ed. St Louis: Elsevier Saunders; 2011. p. 16–26.CrossRef

37.

Friedrich A, Schlarb AA. Let's talk about sleep: a systematic review of psychological interventions to improve sleep in college students. J Sleep Res. 2018;27(1):4–22.PubMedCrossRef

38.

Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. 2006;25(1):3–14.PubMedCrossRef

39.

Morin CM, Colecchi C, Stone J, Sood R, Brink D. Behavioral and pharmacological therapies for late life insomnia. JAMA. 1999;281(11):991–9.PubMedCrossRef

40.

Silversten B, Omvik S, Pallesen S, Bjorvatn B, Havik OE, Neilsen GH, et al. Cognitive Behavioral Therapy vs Zopiclone for Treatment of Chronic Primary Insomnia in Older Adults A Randomized Controlled Trial. JAMA. 2006;295(24):2851–8.CrossRef

41.

Mean MK, Lichstein KL, Epperson MT, Johnson CT. Relaxation therapy for insomnia: nighttime and day time effects. Behav Res Ther. 2000;38:665–78.CrossRef

42.

Sun J, Kang J, Wang P, Zeng H. Self-relaxation training can improve sleep quality and cognitive functions in the older: a one-year randomised controlled trial. J Clin Nurs. 2013;22(9-10):1270–80.PubMedCrossRef

43.

Gong H, Ni CX, Liu YZ, Zhang Y, Su WJ, Lian YJ, et al. Mindfulness meditation for insomnia: a meta-analysis of randomized controlled trials. J Psychosom Res. 2016;89:1–6.PubMedCrossRef

44.

Wang YY, Wang F, Zheng W, Zhang L, Ng CH, Ungvari GS, et al. Mindfulness-based interventions for insomnia: a meta-analysis of randomized controlled trials. Behav Sleep Med. 2018;18(1):1–9.

45.

Garland SN, Zhou ES, Gonzalez BD, Rodriguez N. The quest for mindful sleep: a critical synthesis of the impact of mindfulness-based interventions for insomnia. Curr Sleep Med Rep. 2016;2(3):142–51.PubMedPubMedCentralCrossRef

46.

Van Gordon W, Shonin E, Dunn TJ, Garcia-Campayo J, Griffiths MD. Meditation awareness training for the treatment of fibromyalgia syndrome: a randomized controlled trial. Br J Health Psychol. 2017;22(1):186–206.PubMedCrossRef

47.

Reid KJ, Baron KG, Lu B, Naylor E, Wolfe L, Zee PC. Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia. Sleep Med. 2010;11(9):934–40.PubMedPubMedCentralCrossRef

48.

Sharif F, Seddigh M, Jahanbin I, Keshayarzi S. The effect of aerobic exercise on quantity and quality of sleep among elderly people referring to health centers of Lar City, Southern of Iran; a randomized controlled clinical trial. Curr Aging Sci. 2015;8:248–55.PubMedCrossRef

49.

Banno M, Harada Y, Taniguchi M, Tobita R, Tsujimoto H, Tsujimoto Y, et al. Exercise can improve sleep quality: a systematic review and meta-analysis. PeerJ. 2018;6:e5172.PubMedPubMedCentralCrossRef

50.

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.PubMedPubMedCentralCrossRef

51.

Wight D, Wimbush E, Jepson R, Doi L. Six steps in quality intervention development (6SQuID). J Epidemiol Community Health. 2016;70(5):520–5.PubMedCrossRef

52.

O'Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, et al. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019;9(8):e029954.PubMedPubMedCentralCrossRef

53.

Webb TL, Joseph J, Yardley L, Michie S. Using the internet to promote health behavior change: a systematic review and meta-analysis of the impact of theoretical basis, use of behavior change techniques, and mode of delivery on efficacy. J Med Internet Res. 2010;12(1):e4.PubMedPubMedCentralCrossRef

54.

Ryan RM, Patrick H, Deci EL, Williams GC. Facilitating health behaviour change and its maintenance: interventions based on self determination theory. Eur Health Psychol. 2008;1:2–5.

55.

Cameron L, Leventhal H. Self-regulation, health, and illness: an overview. In: Cameron L, Leventhal H, editors. The self-regulation of health and illness behaviour. London: Routledge; 2002.

56.

Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000;55:68–78.PubMedCrossRef

57.

Espie CA, Farias Machado P, Carl JR, Kyle SD, Cape J, Siriwardena AN, et al. The sleep condition indicator: reference values derived from a sample of 200 000 adults. J Sleep Res. 2018;27(3):e12643.PubMedCrossRef

58.

Chung F, Abdullah HR, Liao P. STOP-Bang questionnaire: a practical approach to screen for obstructive sleep apnea. Chest. 2016;149(3):631–8.PubMedCrossRef

59.

Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;3:117.CrossRef

60.

Tracy SJ. Qualitative quality: eight “big-tent” criteria for excellent qualitative research. Qual Inq. 2010;16(10):837–51.CrossRef

61.

Allen KD, Renner JB, Devellis B, Helmick CG, Jordan JM. Osteoarthritis and sleep: the johnston county osteoarthritis project. J Rheumatol. 2008;35(6):1102–7.PubMedPubMedCentral

62.

Deci EL, Ryan RM. The “What” and “Why” of goal pursuits: human needs and the self-determination of behavior. Psychol Inq. 2000;11(4):227–68.CrossRef

63.

Leventhal H, Diefenbach M, Leventhal EA. Illness cognition: using common sense to understand treatment adherence and affect cognition interactions. Cogn Ther Res. 1992;16(2):143–63.CrossRef

64.

Vlaeyen JW, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000;85:317–32.PubMedCrossRef

65.

Crombez G, Eccleston C, Van Damme S, Vlaeyen JW, Karoly P. Fear-avoidance model of chronic pain: the next generation. Clin J Pain. 2012;28(6):475–83.PubMedCrossRef

66.

Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007;30(1):77–94.PubMedCrossRef

67.

Mackichan F, Adamson J, Gooberman-Hill R. 'Living within your limits': activity restriction in older people experiencing chronic pain. Age Ageing. 2013;42(6):702–8.PubMedCrossRef

68.

Eccleston C, Crombez G, Aldrich S, Stannard C. Attention and somatic awareness in chronic pain. Pain. 1997;72:209–15.PubMedCrossRef

69.

Keogh E, Ellery D, Hunt C, Hannent I. Selective attentional bias for pain-related stimuli amongst pain fearful individuals. Pain. 2001;91:91–100.PubMedCrossRef

70.

London TPIKsC. How the UK is sleepng under lockdown 2020.

71.

Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061.PubMedPubMedCentralCrossRef

Title: Development of a novel intervention to improve sleep and pain in patients undergoing total knee replacement
Authors: K. Whale
R. Gooberman-Hill
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Knee-TEP
Knee-TEP
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06584-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Development of a novel intervention to improve sleep and pain in patients undergoing total knee replacement

Abstract

Background

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

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