The Effects of Perioperative Painting Art Therapy (LOM® Solution Centered Art Therapy) in Surgical Patients

• ClinicalTrials.gov Identifier: NCT04524260
• Recruitment Status: Recruiting
• First Posted: August 24, 2020
• Last Update Posted: February 9, 2021
• Sponsor: University of Zurich
• Information provided by (Responsible Party): University of Zurich

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lower Gastrointestinal Neoplasms Benign; Pancreas Cancer; Posttraumatic Stress Disorder; Depression, Anxiety	Behavioral: perioperative painting art therapy (LOM® solution centered art therapy); Behavioral: perioperative painting art therapy (LOM® solution centered art therapy) - control	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 31, 2020
• Estimated Primary Completion Date: August 31, 2022
• Estimated Study Completion Date: February 28, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Painting art therapy; Intervention group	Behavioral: perioperative 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
Sham Comparator: Usual Care; Control group	Behavioral: perioperative 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.

Outcome Measures

Primary Outcome Measures :

1. Change of Anxiety [ Time Frame: 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 Outcome Measures :

1. Change of Depression [ Time Frame: 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
2. Change of Quality of Life - PROMIS 29 [ Time Frame: 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
3. Change of Health related quality of life - SF-12 [ Time Frame: 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 Outcome Measures:

1. Change of Postoperative Pain 1 [ Time Frame: Change from Baseline (NRS pain 0-10) at 6 months post surgery ]
   Subjectively perceived (NRS 0-10)
2. Change of Postoperative Pain 2 [ Time Frame: Change from Baseline (amount of analgesia) at 6 months post surgery ]
   Amount of Analgesia (data)
3. Change of Blood pressure [ Time Frame: Change from Baseline at 6 months post surgery ]
   Systolic and diastolic BP in mmHg
4. Change of Heart Rate [ Time Frame: Change from Baseline at 6 months post surgery ]
   HR in bpm (beats per minute)
5. Change of Respiratory Rate [ Time Frame: Change from Baseline at 6 months post surgery ]
   RR/min
6. Laboratory result, chemistry (CRP) [ Time Frame: Change from Baseline at 6 months post surgery ]
   C-reactive protein (mg/l)
7. Laboratory result, hematology (Hb) [ Time Frame: Change from Baseline at 6 months post surgery ]
   Hemoglobin, measured in g/l
8. Laboratory result, hematology (Leucocytes, White Blood Cells) [ Time Frame: Change from Baseline at 6 months post surgery ]
   WBCs measured in G/l
9. Complications (Clavien-Dindo-Classification) [ Time Frame: 6 months ]
   Clavien-Dindo-Classification (classified from 0 - V), higher numbers according to more severe complications, V is dead)
10. Complications (CCI during hospital stay) [ Time Frame: 6 months ]
    CCI during hospital stay; measured from healthy (0) to death (100)
11. Tumor staging assessed according official TNM-Staging [ Time Frame: 1 week postoperative (as soon as final histopathology is available) ]
    TNM-Classification of Malignant Tumors, 8th edition
12. Socio-economic: days in hospital [ Time Frame: up to 6 months post surgery ]
    Days in hospital until discharge, measured in days
13. Socio-economic: days in ICU [ Time Frame: up to 6 months post surgery ]
    Days in ICU until discharge to regular unit, measured in days
14. Socio-economic: ability to return to work [ Time Frame: up to 6 months post surgery ]
    Measured will be the time from surgery until return to work, in weeks

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Eva Breuer, MD; 0041 43 253 78 26; eva.breuer@usz.ch

Locations

Switzerland

Department of Visceral- and Transplantation Surgery, University Hospital Zurich; Recruiting

Zurich, ZH, Switzerland, 8091

Contact: Eva Breuer, MD 0041 43 253 78 26 eva.breuer@usz.ch

Sponsors and Collaborators

University of Zurich

Investigators

• Study Chair: Pierre-Alain Clavien, MD PhD; Department of Visceral- and Transplantation Surgery, University Hospital Zurich

More Information

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT04524260
• Other Study ID Numbers: PAINT - Zurich; 2019-00643 ( Other Identifier: Cantonal Ethics Committee Zurich ); SNCTP000003688 ( Other Identifier: Swiss National Clinical Trials Portal )
• First Posted: August 24, 2020
• Last Update Posted: February 9, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:

painting art therapy; PTSD; alternative/complementary medicine; anxiety

Additional relevant MeSH terms:

Pancreatic Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Diseases; Pharmaceutical Solutions