NCT02988947

Effectiveness of a Psychological Intervention in Patients Undergoing Total Knee Arthroplasty

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Minho · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Arthroplasty, Total

Interventions

Type	Name	Description
OTHER	PNE+HyP	This is a combined PNE and Hypnosis psychological intervention. PNE is a cognitive based approach that highlights the biopsychosocial model of pain and focuses on neurophysiological and neurobiological processes and pain representation. Hypnosis aims at promoting pain control, increasing positive coping strategies, and targeting positive psychological variables.

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-12-18
• Completion: 2020-12-18
• First posted: 2016-12-12
• Last updated: 2021-04-30

Locations

1 site across 1 country: Portugal