Effectiveness of a Psychological Intervention in Patients Undergoing Total Knee Arthroplasty
- Conditions
- Knee Arthroplasty, Total
- Interventions
- Other: PNE+HyP
- Registration Number
- NCT02988947
- Lead Sponsor
- University of Minho
- Brief Summary
The purpose of this study is to evaluate the effectiveness of a combined Pain Neuroscience Education (PNE) and Hypnosis (HyP) psychological intervention aiming at the control and prevention of pain and promotion of post-surgical recovery in patients undergoing Total Knee Arthroplasty
- Detailed Description
This is a prospective Randomized Controlled Trial (RCT), comparing an experimental group (EG), submitted to a PNE/HyP based psychological intervention, and a control group (CG), submitted to usual treatment and care.
After recruitment and evaluation of inclusion/exclusion criteria, patients entering the study will sign the Informed Consent. Baseline evaluation is performed at 1 month pre-surgery and, afterwards, patients are randomly assigned to EG (PNE+Hyp plus usual care) or CG (usual care only). The EG will be submitted to 3 pre-surgical and 1 (or 2) post-surgical reinforcement sessions. At 1 month post-surgery, the intervention group will be subdivided and participants will be randomly assigned to receive a reinforcement session or no intervention at this point. The psychological intervention sessions are based on the educative principles of Pain Neuroscience Education and on Hypnosis strategies for the promotion of pain control, positive coping strategies and psychological variables.
Patients will be evaluated on 6 moments: T0 - baseline, 1 month pre surgery; T1 - post intervention/24h before surgery; T2 - 72h post-surgery; T3 - 1 month post surgery; T4 - 6 months post surgery; T5 - 12 months post intervention. Patients will fill in self report measures and perform physiological evaluation to analyse relevant bio-markers (salivary cortisol and α-amylase) that are related to stress levels and SNS functioning and translate the impact of psychological interventions on physiological parameters.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- Planned unilateral total knee arthroplasty due to gonarthrosis
- Giving consent to participate
- Inability to write and read
- Cognitive deficit (assessed by MMSE)
- Revision TKA
- Bilateral TKA
- TKA for reasons other than gonarthrosis (fracture, malignancy or infection)
- Psychiatric or neurological deficit (e.g. Schizophrenia or Alzheimers')
- Diagnosis of rheumatoid arthritis, Psoriatic arthritis, Systemic lupus erythematosus, Anquilosant spondylitis or other severe disease
- Contralateral hip or knee arthroplasty in the previous 6 months
- Planned contralateral hip or knee arthroplasty in the next 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group (PNE+HyP) PNE+HyP Patients in this group will have 3 pre-surgical + 1 (or 2) reinforcement sessions in adition to standard TKA care. These interventions are based on Pain Neuroscience Education and Hypnosis and delivered according to standardized scripts.
- Primary Outcome Measures
Name Time Method Pain intensity 72h post-surgery as assessed by NRS 72h post-surgery Pain intensity 1 month post-surgery as assessed by NRS and WOMAC 1 month post-surgery Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC 24h before surgery Pain intensity 6 months post-surgery as assessed by NRS and WOMAC 6 months post-surgery Pain intensity 12 months post-surgery as assessed by NRS and WOMAC 12 months post-surgery
- Secondary Outcome Measures
Name Time Method Salivary α-amylase levels 72h post-surgery 72h post-surgery Pain knowledge 6 months post-surgery as assessed by NPQ 6 months post-surgery Physical functioning post-intervention as assessed by WOMAC 24h before surgery Physical functioning 12 months post-surgery as assessed by WOMAC 12 months post-surgery Pain knowledge post-intervention as assessed by the Neurophisiology of Pain Questionnaire (NPQ) 24h before surgery Pain knowledge 1 month post-surgery as assessed by the NPQ 1 month post-surgery Pain knowledge 12 months post-surgery as assessed by NPQ 12 months post-surgery Physical functioning 1 month post-surgery as assessed by WOMAC 1 month post-surgery Physical functioning 6 months post-surgery as assessed by WOMAC 6 months post-surgery Emotional distress post-intervention as assessed by the Hospital Anxiety and Depression Scale (HADS) 24h before surgery Emotional distress 6 months post-surgery as assessed by HADS 6 months post-surgery Emotional distress 12 months post-surgery as assessed by HADS 12 months post-surgery Optimism post-intervention as assessed by the Life Orientation Test (LOT-R) 24h before surgery Optimism 1 month post-surgery as assessed by LOT 1 month post-surgery Hope at 12 months post-surgery as assessed by ESE 12 months post-surgery Pain coping strategies 1 month post-surgery as assessed by CSQ 1 month post-surgery Pain coping strategies at 12 months post-surgery as assessed by CSQ 12 months post-surgery Emotional distress 1 month post-surgery as assessed by HADS 1 month post-surgery Optimism 12 months post-surgery as assessed LOT-R 12 months post-surgery Pain coping strategies post-intervention as assessed by the Coping Strategies Questionnaire (CSQ) 24h before surgery Optimism 6 months post-surgery as assessed by LOT-R 6 months post-surgery Pain coping strategies at 6 months post-surgery as assessed by CSQ 6 months post-surgery Hope at 1 month post-surgery as assessed by ESE 1 month post-surgery Hope at 6 months post-surgery as assessed by ESE 6 months post-surgery Hope post-intervention as assessed by the Portuguese Hope Scale (Escala Sobre a Esperança - ESE) 24h before surgery Self-Efficacy post-intervention as assessed by the Self-Efficacy Scale developed for this study (KSESS) 24h before surgery Self-Efficacy at 1 month post-surgery as assessed by KSESS 1 month post-surgery Salivary cortisol levels post-intervention 24h before surgery Salivary cortisol levels 72h post-surgery 72h post-surgery Salivary cortisol levels at 1 month post-surgery 1 month post-surgery Salivary cortisol levels at 12 months post-surgery 12 months post-surgery Salivary α-amylase levels at 1 month post-surgery 1 month post- surgery Self-Efficacy at 6 months post-surgery as assessed by KSESS 6 months post-surgery Self-Efficacy at 12 months post-surgery as assessed by KSESS 12 months post-surgery Salivary cortisol levels at 6 months post-surgery 6 months post-surgery Salivary α-amylase levels post-intervention 24h before surgery Salivary α-amylase at 6 months post-surgery 6 months post-surgery Salivary α-amylase at 12 months post-surgery 12 months post-surgery Inflammatory biomarkers 24h before surgery IL-1β, IL-6, IL-10, TNFα, MCP-1, hs-CRP
Trial Locations
- Locations (1)
Life and Health Sciences Research Institute
🇵🇹Braga, Portugal