跳至主要内容
临床试验/NCT04669379
NCT04669379终止不适用

Preoperative Optimization of Patient's Expectations by the Use of an Online-Tool - a Randomized Controlled Trial

Philipps University Marburg2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
29
试验地点
2
主要终点
Change in Pain Disability Index (PDI) from Baseline to two days pre-surgery to one week post-surgery to three months post-surgery

研究概览

简要总结

Recovery after the 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. However, the content of these interventions needs further examination. This study aims to examine if the developed preoperative intervention (i) reduces preoperative anxiety, (ii) increases positive expectations, and (iii) improves the long-term outcome and postoperative recovery. Therefore an online-tool has been developed. Using an online-approach makes it possible to reach many patients taking as little time and cost as possible.

Patients who undergo surgery in the next two weeks and want to participate in the study will be asked for the planned surgical procedure. There will be a filter (stratum) for surgery. Patients with the same kind of surgery are randomized into two groups (Control vs. intervention group) after they've filled some questionnaires at the baseline assessment. Following this, the intervention group will participate in the psychological online intervention (around 30 minutes). The intervention will focus on the treatment outcome expectations and personal control expectations to increase patients' positive expectations. The control group will receive no psychological intervention. Both groups will fill out questionnaires again in the evening, two days before the surgery, around one week after the surgery, and three months after the 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
None

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

  • In-patient operation under general anesthetic
  • Age 18 or above
  • Fluency in German
  • Informed consent

排除标准

  • 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 two days pre-surgery to one week post-surgery to three months post-surgery

时间窗: Baseline, 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 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 The Control Attitudes Scale-Revised (CAS-R) from Baseline to one week post-surgery(Baseline, up to one week post-surgery)
  • Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery(Baseline, two days pre-surgery, up to one week post-surgery, up to three months post-surgery)
  • Change in The Primary Appraisal Secondary Appraisal questionnaire (PASA) from Baseline to two days pre-surgery to one week post-surgery(Baseline, two days pre-surgery, up to one week post-surgery, up to three months post-surgery)
  • Change in The Amsterdam Preoperative Anxiety and Information Scale (APAIS) from Baseline to two days pre-surgery(Baseline, two days pre-surgery)

研究者

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

Winfried Rief

Professor, Dr.

Philipps University Marburg

研究点 (2)

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