Depression, Anxiety, Lower Gastrointestinal Neoplasms Benign, Pancreas Cancer, Posttraumatic Stress Disorder
Conditions
Keywords
painting art therapy, PTSD, alternative/complementary medicine, anxiety
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.
Interventions
BEHAVIORALperioperative painting art therapy (LOM® solution centered art therapy)
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
BEHAVIORALperioperative painting art therapy (LOM® solution centered art therapy) - control
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.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Anxiety | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Depression | Change from Baseline PHQ-9-Score up to 6 months post surgery | PHQ-9 (Brief Patient Health Questionnaire-9), scores ranging from 0 to 27, with higher scores correlating with greater depression |
| Change of Quality of Life - PROMIS 29 | Change from Baseline PROMIS 29-Scores up to 6 months post surgery | 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 of Health related quality of life - SF-12 | Change from Baseline SF-12-Scores up to 6 months post surgery | SF-12 (short form 12, 12 question survey), results calculated with scoring programme, with higher scores correlating with lower quality of life |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of Respiratory Rate | Change from Baseline at 6 months post surgery | RR/min |
| Laboratory result, chemistry (CRP) | Change from Baseline at 6 months post surgery | C-reactive protein (mg/l) |
| Laboratory result, hematology (Hb) | Change from Baseline at 6 months post surgery | Hemoglobin, measured in g/l |
| Laboratory result, hematology (Leucocytes, White Blood Cells) | Change from Baseline at 6 months post surgery | WBCs measured in G/l |
| Complications (Clavien-Dindo-Classification) | 6 months | Clavien-Dindo-Classification (classified from 0 - V), higher numbers according to more severe complications, V is dead) |
| Change of Postoperative Pain 1 | Change from Baseline (NRS pain 0-10) at 6 months post surgery | Subjectively perceived (NRS 0-10) |
| Tumor staging assessed according official TNM-Staging | 1 week postoperative (as soon as final histopathology is available) | TNM-Classification of Malignant Tumors, 8th edition |
| Socio-economic: days in hospital | up to 6 months post surgery | Days in hospital until discharge, measured in days |
| Socio-economic: days in ICU | up to 6 months post surgery | Days in ICU until discharge to regular unit, measured in days |
| Socio-economic: ability to return to work | up to 6 months post surgery | Measured will be the time from surgery until return to work, in weeks |
| Complications (CCI during hospital stay) | 6 months | CCI during hospital stay; measured from healthy (0) to death (100) |
| Change of Postoperative Pain 2 | Change from Baseline (amount of analgesia) at 6 months post surgery | Amount of Analgesia (data) |
| Change of Blood pressure | Change from Baseline at 6 months post surgery | Systolic and diastolic BP in mmHg |
| Change of Heart Rate | Change from Baseline at 6 months post surgery | HR in bpm (beats per minute) |
Countries
Switzerland
Contacts
Primary ContactEva Breuer, MD
Outcome results
None listed