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

Posttraumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04524260
• Other study ID #: PAINT - Zurich
• Secondary ID: 2019-00643SNCTP0
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2021
• Source: University of Zurich
• Contact: Eva Breuer, MD
• Phone: 0041 43 253 78 26
• Email: eva.breuer[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression, Anxiety
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Lower Gastrointestinal Neoplasms Benign
• Pancreas Cancer
• Pancreatic Neoplasms
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Visceral- and Transplantation Surgery, University Hospital Zurich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Postoperative Pain 1	Subjectively perceived (NRS 0-10)	Change from Baseline (NRS pain 0-10) at 6 months post surgery
Other	Change of Postoperative Pain 2	Amount of Analgesia (data)	Change from Baseline (amount of analgesia) at 6 months post surgery
Other	Change of Blood pressure	Systolic and diastolic BP in mmHg	Change from Baseline at 6 months post surgery
Other	Change of Heart Rate	HR in bpm (beats per minute)	Change from Baseline at 6 months post surgery
Other	Change of Respiratory Rate	RR/min	Change from Baseline at 6 months post surgery
Other	Laboratory result, chemistry (CRP)	C-reactive protein (mg/l)	Change from Baseline at 6 months post surgery
Other	Laboratory result, hematology (Hb)	Hemoglobin, measured in g/l	Change from Baseline at 6 months post surgery
Other	Laboratory result, hematology (Leucocytes, White Blood Cells)	WBCs measured in G/l	Change from Baseline at 6 months post surgery
Other	Complications (Clavien-Dindo-Classification)	Clavien-Dindo-Classification (classified from 0 - V), higher numbers according to more severe complications, V is dead)	6 months
Other	Complications (CCI during hospital stay)	CCI during hospital stay; measured from healthy (0) to death (100)	6 months
Other	Tumor staging assessed according official TNM-Staging	TNM-Classification of Malignant Tumors, 8th edition	1 week postoperative (as soon as final histopathology is available)
Other	Socio-economic: days in hospital	Days in hospital until discharge, measured in days	up to 6 months post surgery
Other	Socio-economic: days in ICU	Days in ICU until discharge to regular unit, measured in days	up to 6 months post surgery
Other	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
Primary	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	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
Secondary	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
Secondary	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