Effectiveness of a Psychological Intervention for the Control and Prevention of Pain and for Surgical Recovery in Patients Undergoing Total Knee Arthroplasty: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned unilateral total knee arthroplasty due to gonarthrosis
- •Giving consent to participate
排除标准
- •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
结局指标
主要结局
Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC
时间窗: 24h before surgery
Pain intensity 1 month post-surgery as assessed by NRS and WOMAC
时间窗: 1 month post-surgery
Pain intensity 72h post-surgery as assessed by NRS
时间窗: 72h post-surgery
Pain intensity 6 months post-surgery as assessed by NRS and WOMAC
时间窗: 6 months post-surgery
Pain intensity 12 months post-surgery as assessed by NRS and WOMAC
时间窗: 12 months post-surgery
次要结局
- Pain knowledge 6 months post-surgery as assessed by NPQ(6 months post-surgery)
- Optimism 6 months post-surgery as assessed by LOT-R(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)
- 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 levels 72h post-surgery(72h post-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)
研究者
Patrícia Ribeiro Pinto
Post-doctoral fellow
University of Minho