Postoperative Outcome After the Application of Perioperative Painting Art Therapy (LOM® Solution Centered Art Therapy) in Patients Undergoing Major Surgery at the University Hospital of Zurich
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change of Anxiety
研究概览
简要总结
The investigators want to study whether the use of painting art therapy has an influence on the quality of life, the complication rate and the general outcome of major abdominal surgery. The painting art therapy is carried out according to the protocol of (LOM® Solution Centered Art Therapy) by trained painting art therapists.
详细描述
The interest in alternative and complementary medical treatments has increased significantly in recent years and several studies showed a positive effect on the healing process of patients undergoing surgery. Painting art therapy represents another possible form of such a complementary medical treatment. However, the effect in the context of major abdominal surgical interventions has not yet been investigated, which is why the investigators are conducting this study. Selected patients referred to the Department of Visceral and Transplantation Surgery with operable pathologies of the pancreatic and the lower gastrointestinal tract are subjected to perioperative painting art therapy. It is carried out according to the protocol of (LOM® Solution Centered Art Therapy) by trained painting art therapists. The investigators want to evaluate the effectiveness of perioperative painting art therapy by analyzing the results of several questionnaires regarding anxiety and depression levels as well as health related patient data to observe the short/long term outcome and the psychological well-being of patients undergoing major surgery in case of carcinoma. The aim of the study is to assess if painting art therapy, more precisely the LOM®-method, is effective in reducing symptoms of anxiety and depression in patients undergoing surgery. When it appears that the application of perioperative painting art therapy has a major influence on the postoperative outcome in cancer patients, some patients could benefit from a noninvasive, low-risk and easy additional treatment option. This study is a collaboration with the Institute of Complementary and Integrative medicine of the University Hospital Zurich.
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
- 否
入选标准
- •Consecutive adult patients of both genders ≥ 18 years subjected to major (oncological) surgery due to pathologies of the pancreatic and lower gastrointestinal tract at our department.
- •The initial diagnosis does not date back longer than 6 months prior the planned surgery. Neoadjuvant radio-/chemotherapy is not an exclusion criteria.
- •Able to speak and understand German or English
- •Signed written informed consent by the participant after extensive oral and written information about the research project and its aims.
- •Thresholds of primary outcome: anxiety levels measured with STAI-form Y-1 (state) and Y-2 (trait). Thresholds: scores between 20 (minimum) and 80 (maximum) in each subscore.
排除标准
- •Woman who are pregnant or breast feeding.
- •Known or suspected non-compliance regarding the execution of painting art therapy and/or the proper completion of the needed forms.
- •Drug or alcohol abuse.
- •Regular intake of antidepressant medication with the exception of medication prescribed for chronic insomnia.
- •Acute suicidality.
- •Life expectancy less than 9 months after planned surgery.
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, ect. of the participant
- •Participation in another study during the present study and within 6 weeks following the surgery.
- •Previous enrollment into the current study.
- •Enrollment of the investigator, his/her family members, employees and other dependent persons.
结局指标
主要结局
Change of Anxiety
时间窗: Change from Baseline STAI-Score up to 6 months post surgery
State Trait Anxiety Inventory, STAI-forms Y-1/state and Y-2/trait (questionnaire), scores range from 20 to 80, with higher scores correlating with greater anxiety
次要结局
- Change of Depression(Change from Baseline PHQ-9-Score up to 6 months post surgery)
- Change of Quality of Life - PROMIS 29(Change from Baseline PROMIS 29-Scores up to 6 months post surgery)
- Change of Health related quality of life - SF-12(Change from Baseline SF-12-Scores up to 6 months post surgery)