Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-00643 | Other Identifier | Cantonal Ethics Committee Zurich | |
| SNCTP000003688 | Other Identifier | Swiss National Clinical Trials Portal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 (LOMĀ® Solution Centered Art Therapy) by trained painting art therapists.
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 (LOMĀ® 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 LOMĀ®-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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Painting art therapy | Active Comparator | Intervention group |
|
| Usual Care | Sham Comparator | Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perioperative painting art therapy (LOMĀ® solution centered art therapy) | Behavioral | We plan to apply painting art therapy as a health-related intervention to patients coming to our department for elective major surgery of the pancreatic and lower gastrointestinal tract for malignant pathologies. Patients will have 3 patient art therapy sessions: one before surgery, one on day 3-5 after surgery during the hospital stay and one during the follow-up 6 weeks postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Anxiety | 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 | Change from Baseline STAI-Score up to 6 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Depression | PHQ-9 ("Brief Patient Health Questionnaire-9"), scores ranging from 0 to 27, with higher scores correlating with greater depression | Change from Baseline PHQ-9-Score up to 6 months post surgery |
| Change of Quality of Life - PROMIS 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Postoperative Pain 1 | Subjectively perceived (NRS 0-10) | Change from Baseline (NRS pain 0-10) at 6 months post surgery |
| Change of Postoperative Pain 2 | Amount of Analgesia (data) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Breuer, MD | Contact | 0041 43 253 78 26 | eva.breuer@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Pierre-Alain Clavien, MD PhD | Department of Visceral- and Transplantation Surgery, University Hospital Zurich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Visceral- and Transplantation Surgery, University Hospital Zurich | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| perioperative painting art therapy (LOMĀ® solution centered art therapy) - control | Behavioral | "usual care", no particular intervention during the perioperative setting. There will be 2-3 painting art therapy sessions after the follow-up 6 weeks postoperative. Therefore this group is called "usual care"- or delayed intervention group. |
|
PROMIS 29 ("Profile Physical and Mental Health Summary Scores"-questionnaire), scores ranging from 28 to 150, with higher scores correlating with lower quality of life |
| Change from Baseline PROMIS 29-Scores up to 6 months post surgery |
| Change of Health related quality of life - SF-12 | SF-12 ("short form 12", 12 question survey), results calculated with scoring programme, with higher scores correlating with lower quality of life | Change from Baseline SF-12-Scores up to 6 months post surgery |
| Change from Baseline (amount of analgesia) at 6 months post surgery |
| Change of Blood pressure | Systolic and diastolic BP in mmHg | Change from Baseline at 6 months post surgery |
| Change of Heart Rate | HR in bpm (beats per minute) | Change from Baseline at 6 months post surgery |
| Change of Respiratory Rate | RR/min | Change from Baseline at 6 months post surgery |
| Laboratory result, chemistry (CRP) | C-reactive protein (mg/l) | Change from Baseline at 6 months post surgery |
| Laboratory result, hematology (Hb) | Hemoglobin, measured in g/l | Change from Baseline at 6 months post surgery |
| Laboratory result, hematology (Leucocytes, White Blood Cells) | WBCs measured in G/l | Change from Baseline at 6 months post surgery |
| Complications (Clavien-Dindo-Classification) | Clavien-Dindo-Classification (classified from 0 - V), higher numbers according to more severe complications, V is dead) | 6 months |
| Complications (CCI during hospital stay) | CCI during hospital stay; measured from healthy (0) to death (100) | 6 months |
| Tumor staging assessed according official TNM-Staging | TNM-Classification of Malignant Tumors, 8th edition | 1 week postoperative (as soon as final histopathology is available) |
| Socio-economic: days in hospital | Days in hospital until discharge, measured in days | up to 6 months post surgery |
| Socio-economic: days in ICU | Days in ICU until discharge to regular unit, measured in days | up to 6 months post surgery |
| Socio-economic: ability to return to work | Measured will be the time from surgery until return to work, in weeks | up to 6 months post surgery |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided