Clinical trial NCT04524260: The Effects of Perioperative Painting Art Therapy (LOM® Solution Centered Art Therapy) in Surgical Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Gastrointestinal Neoplasms Benign
Pancreas Cancer
Posttraumatic Stress Disorder
Depression, Anxiety
Keywords: painting art therapy
PTSD
alternative/complementary medicine
anxiety
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of Anxiety
timeFrame: Change from Baseline STAI-Score up to 6 months post surgery
Secondary outcomes:
measure: Change of Depression
timeFrame: Change from Baseline PHQ-9-Score up to 6 months post surgery
measure: Change of Quality of Life - PROMIS 29
timeFrame: Change from Baseline PROMIS 29-Scores up to 6 months post surgery
measure: Change of Health related quality of life - SF-12
timeFrame: Change from Baseline SF-12-Scores up to 6 months post surgery
Other outcomes:
measure: Change of Postoperative Pain 1
timeFrame: Change from Baseline (NRS pain 0-10) at 6 months post surgery
measure: Change of Postoperative Pain 2
timeFrame: Change from Baseline (amount of analgesia) at 6 months post surgery
measure: Change of Blood pressure
timeFrame: Change from Baseline at 6 months post surgery
measure: Change of Heart Rate
timeFrame: Change from Baseline at 6 months post surgery
measure: Change of Respiratory Rate
timeFrame: Change from Baseline at 6 months post surgery
measure: Laboratory result, chemistry (CRP)
timeFrame: Change from Baseline at 6 months post surgery
measure: Laboratory result, hematology (Hb)
timeFrame: Change from Baseline at 6 months post surgery
measure: Laboratory result, hematology (Leucocytes, White Blood Cells)
timeFrame: Change from Baseline at 6 months post surgery
measure: Complications (Clavien-Dindo-Classification)
timeFrame: 6 months
measure: Complications (CCI during hospital stay)
timeFrame: 6 months
measure: Tumor staging assessed according official TNM-Staging
timeFrame: 1 week postoperative (as soon as final histopathology is available)
measure: Socio-economic: days in hospital
timeFrame: up to 6 months post surgery
measure: Socio-economic: days in ICU
timeFrame: up to 6 months post surgery
measure: Socio-economic: ability to return to work
timeFrame: up to 6 months post surgery
Locations:
city: Zurich
country: Switzerland
facility: Department of Visceral- and Transplantation Surgery, University Hospital Zurich
state: ZH
Study officials:
affiliation: Department of Visceral- and Transplantation Surgery, University Hospital Zurich
name: Pierre-Alain Clavien, MD PhD
role: STUDY_CHAIR
References: