The Effects Of Perioperative Painting Art Therapy (LOM® Solution Centered Art Therapy) In Surgical Patients

Study Overview

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

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.

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.

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

PAINT - Zurich
2019-00643 (OTHER Identifier) (OTHER: Cantonal Ethics Committee Zurich)
SNCTP000003688 (OTHER Identifier) (OTHER: Swiss National Clinical Trials Portal)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-03-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-02-07
First Submitted that Met QC Criteria 2020-08-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-02-09
First Posted (ACTUAL) 2020-08-24	Results First Posted N/A	Last Verified 2021-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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 s
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.

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 s

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.

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Eva Breuer, MD

Phone Number: 0041 43 253 78 26

Email: eva.breuer@usz.ch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Pierre-Alain Clavien, MD PhD, Department of Visceral- and Transplantation Surgery, University Hospital Zurich

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record