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

NCT03715608 | Completed

• 1 other identifier: tianhua68480
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee; Psychological Disorder; Psychological Intervention; Satisfaction; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• HSS(Hospital for Special Surgery) score

  6 months

• WOMAC(The western Ontario and McMaster universities osteoarthritis index) score

  6 months

Study Arms (2)

Control group

NO INTERVENTION

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

Intervention group

EXPERIMENTAL

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.

Other: Psychological Intervention

Interventions

Psychological Intervention OTHER

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.

Intervention group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking University Sixth Hospital: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee; Mental Disorders; Personal Satisfaction

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice director of department of orthopaedics

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 23, 2018
• Study Start: May 4, 2016
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10