None listed
Conditions
Brief summary
The objectives of this research project are to: (1) identify levels of distress in patients on a waiting list for total joint arthroplasty (TJA), and (2) to determine whether administering an eight-session group mindfulness training intervention prior to surgery will improve the physical recovery of patients undergoing TJA. It is hypothesized that (1) levels of pain will be adversely associated with depression, anxiety and lower Quality of Life; (2) the intervention will lead to better tolerance of symptoms, and improved quality of life. Mindfulness is “the awareness that emerges through paying attention on purpose, in the present moment, and non-judgmentally to the unfolding of experience moment by moment”. Training involves instruction in a number of meditation techniques as well as teaching on how to remain focused on the present moment in day to day activities. There is now extensive scientific evidence showing that mindfulness training leads to an improvement in emotional and physical symptoms in a variety of disorders such as chronic pain, cancer, depression, anxiety and substance use among others. We propose to undertake a 3 year randomised controlled trial in patients with end stage osteoarthritis on the waiting list for TJA. The study will recruit 150 patients and randomly allocate them to receive the current standard of care for TJA or a combination of Mindfulness training (MT) followed by TJA. We plan to measure pain, function, quality of life, coping and mental health via validated questionnaires, as well as the cost effectiveness of a strategy that combines MT and TJA, compared to TJA alone. These measures will be taken prior to surgery and at 3 and 12 months post TJA surgery. Participants will all be followed for one year at which time the benefits in terms of health improvements after TJA will be, compared.
Interventions
The intervention group will participate in a group program called “Mindfulness training” (MT) prior to undergoing total hip or knee replacement. Participants will be required to attend 8 weekly group sessions where they will share their experience with peers and learn a number of mindfulness skills to manage stress. They will also be expected to complete homework exercises 6 days a week in between sessions. Prior to entry to the program one interview will be held with the psychiatrist and one wi
The intervention group will participate in a group program called “Mindfulness training” (MT) prior to undergoing total hip or knee replacement. Participants will be required to attend 8 weekly group sessions where they will share their experience with peers and learn a number of mindfulness skills to manage stress. They will also be expected to complete homework exercises 6 days a week in between sessions. Prior to entry to the program one interview will be held with the psychiatrist and one with the psychologist who will be facilitating the program. This will allow an introduction to the program and an informed decision about whether the program is suitable for them or not. The group sessions will run once a week for 8 weeks. All sessions will be facilitated by both a qualified, trained mindfulness facilitator and will be of 2.5 hours duration. There will be an additional all day session on the Saturday of the 6th week and you will be invited back for a “booster” day-long work shop 3 months post-surgery. The session will provide you with education regarding the psychological impact of chronic pain and stress and will teach you a number of different mindfulness skills. At the completion of each session participants will be given mindfulness exercises to practise during the week. All sessions will take place in a group room at the study institution. Total knee replacement is a single surgical procedure whereby the diseased knee joint is replaced with artificial one. The knee is a hinge joint which provides motion at the point where the thigh meets the lower leg. During a total knee replacement, the end of the thigh (femur) bone is removed and replaced with a metal shell. The end of the lower leg bone (tibia) is also removed and replaced with a channelled plastic piece with a metal stem. Depending on the condition of the kneecap portion of the knee joint, a plastic "button" may also be added under the kneecap surface. The procedure is performed under either a general or spinal anaesthetic and takes about 1 hour Total hip replacement is a single surgical procedure whereby the diseased hip joint is replaced with an artificial one. The hip joint is composed of a ball and socket, with the surface of each covered by cartilage. A number of conditions and diseases can cause the cartilage surfaces to degenerate, which in turn leads to pain, stiffness, and disability. Both the ball (femoral head) and socket (acetabulum) are replaced during total hip replacement surgery. Different materials can be used in total hip replacement. Commonly, the femoral head is replaced with a metal ball and stem and a metal cup is secured into the acetabulum with a polyethylene socket. The procedure is performed under either a general or spinal anaesthetic and takes about 1 hour
Sponsors
Professor Peter Choong
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
On the surgical waiting list for primary total joint replacement for end stage osteoarthritis at the study institution
Exclusion criteria
(i) Revision surgery or surgery for neoplastic disease; (ii) Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia) (mild cognitive impairment (MCI) would not be cause for exclusion); (iii) active drug or alcohol use disorder which in the opinion of the investigators makes the patient unsuitable for participation in the trial (iv) limited English language fluency (v) evidence at interview or on the Memory Complaints Questionnaire (MCQ) of presumptive cognitive impairment requiring clinical assessment.
Outcome results
None listed