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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder; Pancreas Cancer; Depression, Anxiety; Lower Gastrointestinal Neoplasms Benign
• Intervention / Treatment: Behavioral: perioperative painting art therapy (LOM® solution centered art therapy); Behavioral: perioperative painting art therapy (LOM® solution centered art therapy) - control

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Breuer, MD; Phone Number: 0041 43 253 78 26; Email: eva.breuer@usz.ch

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • Recruiting
      • Department of Visceral- and Transplantation Surgery, University Hospital Zurich
      • Contact: Eva Breuer, MD; Phone Number: 0041 43 253 78 26; Email: eva.breuer@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2020
• Primary Completion (ANTICIPATED): August 31, 2022
• Study Completion (ANTICIPATED): February 28, 2023

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (ACTUAL): August 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 7, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: PTSD; anxiety; alternative/complementary medicine; painting art therapy
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Trauma and Stressor Related Disorders; Pancreatic Diseases; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Pancreatic Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Pharmaceutical Solutions
• Other Study ID Numbers: PAINT - Zurich; 2019-00643 (OTHER: Cantonal Ethics Committee Zurich); SNCTP000003688 (OTHER: Swiss National Clinical Trials Portal)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No