search
Back to results

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

Primary Purpose

Lower Gastrointestinal Neoplasms Benign, Pancreas Cancer, Posttraumatic Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
perioperative painting art therapy (LOM® solution centered art therapy)
perioperative painting art therapy (LOM® solution centered art therapy) - control
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Gastrointestinal Neoplasms Benign focused on measuring painting art therapy, PTSD, alternative/complementary medicine, anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Visceral- and Transplantation Surgery, University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Painting art therapy

Usual Care

Arm Description

Intervention group

Control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of Depression
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
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
SF-12 ("short form 12", 12 question survey), results calculated with scoring programme, with higher scores correlating with lower quality of life

Full Information

First Posted
March 19, 2020
Last Updated
February 7, 2021
Sponsor
University of Zurich
search

1. Study Identification

Unique Protocol Identification Number
NCT04524260
Brief Title
The Effects of Perioperative Painting Art Therapy (LOM® Solution Centered Art Therapy) in Surgical Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Gastrointestinal Neoplasms Benign, Pancreas Cancer, Posttraumatic Stress Disorder, Depression, Anxiety
Keywords
painting art therapy, PTSD, alternative/complementary medicine, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Painting art therapy
Arm Type
Active Comparator
Arm Description
Intervention group
Arm Title
Usual Care
Arm Type
Sham Comparator
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
perioperative painting art therapy (LOM® solution centered art therapy)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
perioperative painting art therapy (LOM® solution centered art therapy) - control
Intervention Description
"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 Measure Information:
Title
Change of Anxiety
Description
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
Time Frame
Change from Baseline STAI-Score up to 6 months post surgery
Secondary Outcome Measure Information:
Title
Change of Depression
Description
PHQ-9 ("Brief Patient Health Questionnaire-9"), scores ranging from 0 to 27, with higher scores correlating with greater depression
Time Frame
Change from Baseline PHQ-9-Score up to 6 months post surgery
Title
Change of Quality of Life - PROMIS 29
Description
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
Time Frame
Change from Baseline PROMIS 29-Scores up to 6 months post surgery
Title
Change of Health related quality of life - SF-12
Description
SF-12 ("short form 12", 12 question survey), results calculated with scoring programme, with higher scores correlating with lower quality of life
Time Frame
Change from Baseline SF-12-Scores up to 6 months post surgery
Other Pre-specified Outcome Measures:
Title
Change of Postoperative Pain 1
Description
Subjectively perceived (NRS 0-10)
Time Frame
Change from Baseline (NRS pain 0-10) at 6 months post surgery
Title
Change of Postoperative Pain 2
Description
Amount of Analgesia (data)
Time Frame
Change from Baseline (amount of analgesia) at 6 months post surgery
Title
Change of Blood pressure
Description
Systolic and diastolic BP in mmHg
Time Frame
Change from Baseline at 6 months post surgery
Title
Change of Heart Rate
Description
HR in bpm (beats per minute)
Time Frame
Change from Baseline at 6 months post surgery
Title
Change of Respiratory Rate
Description
RR/min
Time Frame
Change from Baseline at 6 months post surgery
Title
Laboratory result, chemistry (CRP)
Description
C-reactive protein (mg/l)
Time Frame
Change from Baseline at 6 months post surgery
Title
Laboratory result, hematology (Hb)
Description
Hemoglobin, measured in g/l
Time Frame
Change from Baseline at 6 months post surgery
Title
Laboratory result, hematology (Leucocytes, White Blood Cells)
Description
WBCs measured in G/l
Time Frame
Change from Baseline at 6 months post surgery
Title
Complications (Clavien-Dindo-Classification)
Description
Clavien-Dindo-Classification (classified from 0 - V), higher numbers according to more severe complications, V is dead)
Time Frame
6 months
Title
Complications (CCI during hospital stay)
Description
CCI during hospital stay; measured from healthy (0) to death (100)
Time Frame
6 months
Title
Tumor staging assessed according official TNM-Staging
Description
TNM-Classification of Malignant Tumors, 8th edition
Time Frame
1 week postoperative (as soon as final histopathology is available)
Title
Socio-economic: days in hospital
Description
Days in hospital until discharge, measured in days
Time Frame
up to 6 months post surgery
Title
Socio-economic: days in ICU
Description
Days in ICU until discharge to regular unit, measured in days
Time Frame
up to 6 months post surgery
Title
Socio-economic: ability to return to work
Description
Measured will be the time from surgery until return to work, in weeks
Time Frame
up to 6 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Breuer, MD
Phone
0041 43 253 78 26
Email
eva.breuer@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Alain Clavien, MD PhD
Organizational Affiliation
Department of Visceral- and Transplantation Surgery, University Hospital Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Visceral- and Transplantation Surgery, University Hospital Zurich
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Breuer, MD
Phone
0041 43 253 78 26
Email
eva.breuer@usz.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs