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

February 7, 2021 updated by: University of Zurich

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • Recruiting
        • Department of Visceral- and Transplantation Surgery, University Hospital Zurich
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline STAI-Score up to 6 months post surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline PHQ-9-Score up to 6 months post surgery
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
Change from Baseline PROMIS 29-Scores up to 6 months post surgery
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
Change from Baseline SF-12-Scores up to 6 months post surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of Postoperative Pain 1
Time Frame: Change from Baseline (NRS pain 0-10) at 6 months post surgery
Subjectively perceived (NRS 0-10)
Change from Baseline (NRS pain 0-10) at 6 months post surgery
Change of Postoperative Pain 2
Time Frame: Change from Baseline (amount of analgesia) at 6 months post surgery
Amount of Analgesia (data)
Change from Baseline (amount of analgesia) at 6 months post surgery
Change of Blood pressure
Time Frame: Change from Baseline at 6 months post surgery
Systolic and diastolic BP in mmHg
Change from Baseline at 6 months post surgery
Change of Heart Rate
Time Frame: Change from Baseline at 6 months post surgery
HR in bpm (beats per minute)
Change from Baseline at 6 months post surgery
Change of Respiratory Rate
Time Frame: Change from Baseline at 6 months post surgery
RR/min
Change from Baseline at 6 months post surgery
Laboratory result, chemistry (CRP)
Time Frame: Change from Baseline at 6 months post surgery
C-reactive protein (mg/l)
Change from Baseline at 6 months post surgery
Laboratory result, hematology (Hb)
Time Frame: Change from Baseline at 6 months post surgery
Hemoglobin, measured in g/l
Change from Baseline at 6 months post surgery
Laboratory result, hematology (Leucocytes, White Blood Cells)
Time Frame: Change from Baseline at 6 months post surgery
WBCs measured in G/l
Change from Baseline at 6 months post surgery
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)
6 months
Complications (CCI during hospital stay)
Time Frame: 6 months
CCI during hospital stay; measured from healthy (0) to death (100)
6 months
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
1 week postoperative (as soon as final histopathology is available)
Socio-economic: days in hospital
Time Frame: up to 6 months post surgery
Days in hospital until discharge, measured in days
up to 6 months post surgery
Socio-economic: days in ICU
Time Frame: up to 6 months post surgery
Days in ICU until discharge to regular unit, measured in days
up to 6 months post surgery
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
up to 6 months post surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Pierre-Alain Clavien, MD PhD, Department of Visceral- and Transplantation Surgery, University Hospital Zurich

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 Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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