Effectiveness of a Psychological Intervention in Patients Undergoing Total Knee Arthroplasty
NCT ID: NCT02988947
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2018-01-01
2020-12-18
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention Group (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.
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.
Control Group
No intervention / Standard care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Giving consent to participate
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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Hospital de Braga
OTHER
University of Minho
OTHER
Responsible Party
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Patrícia Ribeiro Pinto
Post-doctoral fellow
Locations
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Life and Health Sciences Research Institute
Braga, , Portugal
Countries
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Other Identifiers
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SFRH/BPD/103529/2014
Identifier Type: -
Identifier Source: org_study_id
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