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The preparation for knee surgery study: Psychological therapy to prepare for knee joint replacement

Psychological therapy to prepare for knee joint replacement: A feasibility trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001095853
Enrollment
30
Registered
2021-08-18
Start date
2021-04-06
Completion date
2022-02-25
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: Persistent pain affects approximately 20% of patients after total knee replacement (arthroplasty; TKA), and psychological factors, such pain expectations and anxiety, are good predictors of who develops persistent pain in this group. However, little research has examined whether psychological treatments that target these risk factors could limit the development of persistent pain. The aims of the current study are to pilot test a brief psychological intervention in patients scheduled for TKA, to assess the acceptability and feasibility of the intervention to inform a future randomised controlled trial. Methods: Patients who have elevated anxiety and high expected pain will be recruited from TKA waiting lists at North Shore Hospital and will be invited to take part in a psychological intervention. This will focus on anxiety management and reducing pain expectations. A sample of 30 patients will be recruited. Before and after the intervention and 6 months after surgery, participants will complete measures of pain, anxiety, pain expectations and related outcomes. After each module participants will be asked for feedback and rate the treatment. Data will also be collected on recruitment and completion rates, completeness of data, and preferences for online versus workbook format materials. Analyses: Descriptive statistics will be used to describe recruitment and completion rates, and treatment acceptability ratings. Change in questionnaire scores from pre- to post- intervention will be assessed. 6-month data will be compared to a historic cohort of age and sex-matched TKA patients to calculate effect sizes for a power analysis for a future RCT. Participant feedback will be summarised.

Interventions

Psychological Intervention prior to surgery. Participants will be recruited to begin the intervention approx 3 months prior to surgery. The cognitive-behavioural therapy and pain neuroscience-education based psychological intervention aims to alter pain expectations and anxiety. The intervention includes 3 individual fortnightly phone/video call appointments (2x1hr, 1x20min) accompanied by a information book, workbook, and website including a social modelling video and recordings of relaxatio

Psychological Intervention prior to surgery. Participants will be recruited to begin the intervention approx 3 months prior to surgery. The cognitive-behavioural therapy and pain neuroscience-education based psychological intervention aims to alter pain expectations and anxiety. The intervention includes 3 individual fortnightly phone/video call appointments (2x1hr, 1x20min) accompanied by a information book, workbook, and website including a social modelling video and recordings of relaxation techniques (all created specifically for the study). Participants do the intervention in their own homes. The intervention is provided by one of two health psychologists with 4 & 15 years' clinical experience each. The appointments include discussion of: Appt 1: Pain neuroscience and how this might influence post-operative pain, strategies to manage pain, goal setting for meaningful activities after surgery. Appt 2: Follow-up on goal setting, the influence of stress and anxiety on pain, physiology of stress, using relaxation techniques, instructions for practice. Appt 3: Recap previous content, review use of relaxation techniques, plans for using pain management strategies at time of surgery. Adherence will be monitored using session attendance checklists, recording of homework activities (watched video, set 3 goals, practiced relaxation techniques) and participants are asked to rate the extent to which they read the workbook and website. The intervention was designed to later be combined with multi-modal interventions (e.g. exercise, medication management) to prevent the development of chronic pain after surgery, but is being tested for acceptability and feasibility as a single-modal intervention in this study.

Sponsors

North Shore Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Planned first primary unilateral TKA 2. Fluent in English 3. 18yrs or older 4. Elevated anxiety and expected pain post-surgery: a. 6-item short-form trait anxiety scale from State-Trait Anxiety Inventory score >/= 11 (sum of items 22, 26, 27, 29, 34, 36, 40), and b. Expected Pain: Measured by a single question: ‘Please indicate the level of pain you think you will experience in your operated knee six months after your surgery (0-10)’; scores >/= 1/10.

Exclusion criteria

Inability to give informed consent Illiteracy Diagnosis of cognitive impairment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026