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临床试验/NCT04502121
NCT04502121已完成不适用

Preoperative Optimization of Cardiac Valve Patients' Expectations - a Randomized Controlled Trial

Philipps University Marburg Medical Center2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2020年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
2
主要终点
Change in Pain Disability Index (PDI) from Baseline to one day pre-surgery to one week post-surgery to three months post-surgery

研究概览

简要总结

Recovery after surgery depends on psychological factors such as preoperative information, expectations and surgery-associated anxiety. Prior studies have shown that even short preoperative psychological interventions can improve postoperative outcomes in heart surgery patients. However, what content works best for which patient group and how long an intervention has to be is still largely unknown. The aims of this study are thus to examine if the developed preoperative psychological intervention (i) reduces preoperative anxiety, (ii) increases positive expectations, and (iii) improves the long-term outcome postoperative recovery. Therefore, a brief intervention has been developed. Heart valve patients who undergo a heart surgery will be randomized into two groups (Control vs. intervention group) after baseline assessment. Following this the intervention group will participate in the psychological intervention (30-40 minutes). To increase patients' positive expectations the intervention will focus on treatment outcome expectations and personal control expectations. Furthermore, patients in the intervention group will have two booster-telephone calls (four and eight weeks after the surgery) to check if their developed plans work out. The control group will receive the standard medical procedure. Both groups will fill out questionnaires again at the evening before the surgery, around one week after the surgery and three months after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

盲法说明

The psychologist will inform the patient about the group s/he is randomly assigned to. The medical staff will not receive any information about the group a patient is allocated to and therefore be masked regarding group assignments.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are scheduled for elective cardiac valve procedure
  • Age 18 or above
  • Fluency in German
  • Informed consent

排除标准

  • Comorbid medical/psychiatric condition that causes more extensive disability than the coronary condition
  • Participation in other research programs: in agreement with Coordinating Investigator patient can participate substudies, if this do not interfere with the main study
  • Emergency surgery

结局指标

主要结局

Change in Pain Disability Index (PDI) from Baseline to one day pre-surgery to one week post-surgery to three months post-surgery

时间窗: Baseline, one day pre-surgery, up to one week post-surgery, up to three months post-surgery

Items range from 0 (no disability at all) - 10 (total disability). Consequently higher scores mean a worse outcome.

次要结局

  • Change in Generalized Anxiety Disorder 7 (GAD-7) from Baseline to one week post-surgery to three months post-surgery(Baseline, up to one week post-surgery, up to three months post-surgery)
  • Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery to three months post-surgery(Baseline, up to one week post-surgery, up to three months post-surgery)
  • Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery(Baseline, up to one week post-surgery, up to three months post-surgery)
  • Change in Anxiety (The Amsterdam Preoperative Anxiety and Information Scale, APAIS) from Baseline to one day pre-surgery(Baseline, one day pre-surgery)
  • Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from Baseline to one week post-surgery to three months post-surgery(Baseline, up to one week post-surgery, up to three months post-surgery)
  • Days the patient stays in the hospital, days at the intensive care unit(up to one week post-surgery)
  • Change of Concentration of Inflammatory marker C-reactive protein (CRP) in mg/l(Baseline, up to one day, two days and five days post-surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Winfried Rief

Prof. Dr.

Philipps University Marburg Medical Center

研究点 (2)

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