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Total Knee Arthroplasty Combined With Psychological Intervention for Patients With Psychological Disorders

Primary Purpose

Osteoarthritis, Knee, Psychological Disorder, Psychological Intervention

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychological Intervention
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed written informed consent;
  • Willingness to complete the assessment and an examination using a psychometric scale
  • No surgical contraindications.

Exclusion Criteria:

  • Patients undergoing revision;
  • Patients with infection;
  • Patients who could not undergo the psychological assessment;
  • Loss to follow-up;
  • Psychological disorders of severe type, which means the patient needs to stop TKA surgery for psychological therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Intervention group

    Arm Description

    Patients in the control group received routine TKA surgery and perioperative management without any other interventions.

    The patients in the intervention group received professional psychological interventions include psychological counseling and corresponding medication after the operation. Other perioperative treatments were the same as the patients in the control group. Psychotherapy was based on the clinical expertise of the psychosocial specialist, who selected the most appropriate plan for each patient.

    Outcomes

    Primary Outcome Measures

    Patient satisfaction with TKA surgery Satisfaction
    A self-administered satisfaction scale (very satisfied, somewhat satisfied, somewhat dissatisfied, very dissatisfied) that assessed overall satisfaction as well as satisfaction with pain relief and the ability to perform daily and leisure activities was administered 6 months postoperatively.

    Secondary Outcome Measures

    HSS(Hospital for Special Surgery) score
    HSS(hospital for special surgery) score HSS(hospital for special surgery) score to evaluate patients postoperative knee joint function. With a total of 100, it has 7 subscales: 1.Pain 0~30; 2. Function 0~22; 3. Mobility 0~18; 4. Flexion deformity 0~10; 6. Stability 0~10; 7. Deduction Item. For each scale, a higher value represents a better outcome. The sum of the subscales is the total score.
    WOMAC(The western Ontario and McMaster universities osteoarthritis index) score
    WOMAC(The western Ontario and McMaster universities osteoarthritis index) score HSS(hospital for special surgery) score to evaluate patients postoperative knee joint function.

    Full Information

    First Posted
    October 14, 2018
    Last Updated
    October 22, 2018
    Sponsor
    Peking University Third Hospital
    Collaborators
    Peking University Sixth Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03715608
    Brief Title
    Total Knee Arthroplasty Combined With Psychological Intervention for Patients With Psychological Disorders
    Official Title
    Total Knee Arthroplasty Combined With Psychological Intervention for Patients With Psychological Disorders to Improve Postoperative Outcome and Patient Satisfaction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 4, 2016 (Actual)
    Primary Completion Date
    July 30, 2018 (Actual)
    Study Completion Date
    July 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University Third Hospital
    Collaborators
    Peking University Sixth Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Objective To evaluate the incidence of psychological problems in total knee arthroplasty (TKA) patients and examine whether perioperative psychological intervention can improve the outcomes of and patient satisfaction with TKA. Methods The investigators will prospectively collect clinical data from 400 patients who underwent primary TKA by the same surgeon at Peking University Third Hospital. The patients will be divided into 3 groups based on psychological status and intervention: the normal group comprised patients with a normal psychological status, while patients with an abnormal psychological status will be randomly divided into the intervention group, which received psychological interventions, and the control group, which do not receive any psychological interventions. The HSS(Hospital of special surgery) and WOMAC scores will be evaluated preoperatively, 3 months postoperatively and 6 months postoperatively. A self-administered satisfaction scale (very satisfied, somewhat satisfied, somewhat dissatisfied, very dissatisfied) that assessed overall satisfaction as well as satisfaction with pain relief and the ability to perform daily and leisure activities will be administered 6 months postoperatively. Hypothesis A certain percentage of TKA patients have preoperative psychological abnormalities. Preoperative psychological abnormalities can have an adverse effect on postoperative improvement in joint function and can reduce patient satisfaction. Preoperative psychological intervention can improve the prognosis of TKA patients with psychological disorders.
    Detailed Description
    Patients with knee osteoarthritis(OA) undergoing primary unilateral TKA at the Department of Orthopedics of Peking University Third Hospital from May 2016 to January 2018 will be prospectively included in the study. Inclusion criteria: (1) Signed written informed consent; (2) Willingness to complete the assessment and an examination using a psychometric scale; (3) No surgical contraindications. Exclusion criteria: (1) Patients undergoing revision; (2) Patients with infection; (3) Patients who could not undergo the psychological assessment; (4) Loss to follow-up; (5) Psychological disorders of severe type, which means the patient needs to stop TKA surgery for psychological therapy. The patients' general preoperative data and joint function scores will be collected. Preoperative psychoanalysis will be conducted by a psychiatrist from Peking University Sixth Hospital to determine the TKA patients' preoperative psychological characteristics. According to the presence or absence of psychological abnormalities, the patients will be divided into a psychological abnormalities group and a normal group. The patients in the normal group will receive routine TKA surgery and perioperative management without any other interventions. A randomized controlled prospective study will be conducted with the patients in the psychological abnormalities group. They will be randomly divided into two groups: the intervention group and the control group. The control group: Like the patients in the normal group, the patients in the control group will receive routine TKA surgery and perioperative management without any other interventions. The intervention group: The patients in the intervention group will receive psychological counseling and corresponding medication after the operation. Other perioperative treatments will be the same as the patients in the control group. Psychotherapy will be based on the clinical expertise of the psychosocial specialist, who will select the most appropriate plan for each patient. The WOMAC and HSS scores of all patients will be analyzed preoperatively, 3 months postoperatively and 6 months postoperatively, and a postoperative satisfaction survey questionnaire will be completed. For every patient in this study, standard TKA and perioperative management will be performed by one experienced surgeon at Peking University Third Hospital. Postoperative follow-up will be performed by a group of doctors who are blinded to the group and intervention information. Psychological status assessment and clinical outcome evaluation The patients' psychological and physical performance will be assessed using the Symptom Checklist (SCL-90), a self-assessment questionnaire that is commonly used to assess patients' psychological health. The SCL-90 has a good ability to identify people with psychological symptoms (especially patients on the border of clinically significant psychological symptoms). To assess whether a patient had a psychological disorder that met the diagnostic criteria before surgery, the MINI-International Neuropsychiatric Interview (MINI) will be used to assess patients with suspected anxiety or depression. The MINI is a short, structured interview for the diagnosis of Diagnostic and Statistical Manual-IV(DSM-IV)and International Classification of Diseases-10(ICD-10 ) axis psychiatric disorders. It can be conducted in a short period of time (average 15 minutes). The Chinese version of the MINI has shown reliability and validity in clinical practice. It has been widely used clinically in China. The HSS and WOMAC scores will be evaluated preoperatively, 3 months postoperatively and 6 months postoperatively. A self-administered satisfaction scale (very satisfied, somewhat satisfied, somewhat dissatisfied, very dissatisfied) that assessed overall satisfaction as well as satisfaction with pain relief and the ability to perform daily and leisure activities will be administered 6 months postoperatively. Psychological intervention There are three main interventions for TKA patients: patient visits and education, medication, and psychological interventions. Patient visits and education: Patient education can shorten hospital stays, reduce surgical complications, relieve preoperative anxiety and depressive symptoms, increase confidence, and improve patient satisfaction. In particular, patients with clear psychological problems should pay attention to and divert disease-related negative emotions, such as tension, fear, depression and anxiety. Drug treatment:Patients who meet the indications for drug treatment should be treated with drugs that are sensitive and effective as recommended by psychiatrists. 2.1 Antidepressants are usually divided into tricyclic antidepressants, tetracyclic antidepressants, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRIs), dopamine reuptake inhibitors, serotonin and desmethyl selective serotonin and norepinephrine reuptake inhibitors (SNRIs), norepinephrine and specific serotonin antidepressants. Among them, SSRIs and SNRIs are widely used in clinical practice. The SSRIs are fluoxetine hydrochloride, paroxetine hydrochloride, sertraline, fluvoxamine, citalopram and escitalopram. The main SNRI drugs are venlafaxine, duloxetine and milnacipran. 2.2 Anti-anxiety drugs are mainly benzodiazepines, such as diazepam, alprazolam, and clonazepam, and aromatic piperazine anxiolytics, such as buspirone. Psychological interventions include cognitive and behavioral therapy, supportive therapy, relaxation therapy, and such methods as group therapy, motivational interview therapy, and interpersonal psychotherapy. Each patient has his or her own psychological characteristics. It most effective for a psychiatrist to develop a personalized psychological intervention program based on the patient's psychological characteristics. Ethics approval This study has been approved by the Ethics Committee of Peking University Third Hospital. The enrolled patients can choose to withdraw unconditionally at any time during the study, and the investigators guarantee that the patient's TKA surgery would continue unaffected. Statistical analysis The data distribution will be normal according to the Kolmogorov-Smirnov test. Descriptive statistics will be used to analyze the demographic data and other baseline features, and the number, mean, and standard deviation values will be calculated for continuous variables. Pearson correlations and paired T tests for preoperative and postoperative data comparisons will be used to evaluate the relationship between different variables. The inferential statistics results (P values) are listed as descriptive results. SPSS (Version 19, SPSS, Inc., Chicago IL) will be used for the statistical analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee, Psychological Disorder, Psychological Intervention, Satisfaction, Total Knee Arthroplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients in the control group received routine TKA surgery and perioperative management without any other interventions.
    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    The patients in the intervention group received professional psychological interventions include psychological counseling and corresponding medication after the operation. Other perioperative treatments were the same as the patients in the control group. Psychotherapy was based on the clinical expertise of the psychosocial specialist, who selected the most appropriate plan for each patient.
    Intervention Type
    Other
    Intervention Name(s)
    Psychological Intervention
    Intervention Description
    The patients in the intervention group received psychological counseling and corresponding medication after the operation. Psychotherapy was based on the clinical expertise of the psychosocial specialist from Peking University Sixth Hospital, who selected the most appropriate plan for each patient.
    Primary Outcome Measure Information:
    Title
    Patient satisfaction with TKA surgery Satisfaction
    Description
    A self-administered satisfaction scale (very satisfied, somewhat satisfied, somewhat dissatisfied, very dissatisfied) that assessed overall satisfaction as well as satisfaction with pain relief and the ability to perform daily and leisure activities was administered 6 months postoperatively.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    HSS(Hospital for Special Surgery) score
    Description
    HSS(hospital for special surgery) score HSS(hospital for special surgery) score to evaluate patients postoperative knee joint function. With a total of 100, it has 7 subscales: 1.Pain 0~30; 2. Function 0~22; 3. Mobility 0~18; 4. Flexion deformity 0~10; 6. Stability 0~10; 7. Deduction Item. For each scale, a higher value represents a better outcome. The sum of the subscales is the total score.
    Time Frame
    6 months
    Title
    WOMAC(The western Ontario and McMaster universities osteoarthritis index) score
    Description
    WOMAC(The western Ontario and McMaster universities osteoarthritis index) score HSS(hospital for special surgery) score to evaluate patients postoperative knee joint function.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed written informed consent; Willingness to complete the assessment and an examination using a psychometric scale No surgical contraindications. Exclusion Criteria: Patients undergoing revision; Patients with infection; Patients who could not undergo the psychological assessment; Loss to follow-up; Psychological disorders of severe type, which means the patient needs to stop TKA surgery for psychological therapy.

    12. IPD Sharing Statement

    Learn more about this trial

    Total Knee Arthroplasty Combined With Psychological Intervention for Patients With Psychological Disorders

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