Total Knee Arthroplasty Combined With Psychological Intervention for Patients With Psychological Disorders to Improve Postoperative Outcome and Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Patient satisfaction with TKA surgery Satisfaction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent;
- •Willingness to complete the assessment and an examination using a psychometric scale
- •No surgical contraindications.
排除标准
- •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.
研究组 & 干预措施
Control group
Patients in the control group received routine TKA surgery and perioperative management without any other interventions.
Intervention group
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.
干预措施: Psychological Intervention (Other)
结局指标
主要结局
Patient satisfaction with TKA surgery Satisfaction
时间窗: 6 months
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.
次要结局
- HSS(Hospital for Special Surgery) score(6 months)
- WOMAC(The western Ontario and McMaster universities osteoarthritis index) score(6 months)
研究者
Tian Hua
vice director of department of orthopaedics
Peking University Third Hospital