JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

Studienbeginn:
August 2020

Letztes Update:
09.02.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Pancreatic Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Stress Disorders, Post-Traumatic

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Zurich

Collaborator:
-

Studienleiter

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

Kontakt

Eva Breuer, MD
Kontakt:
Phone: 0041 43 253 78 26
E-Mail: eva.breuer@usz.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Visceral- and Transplantation Surgery, University Hospital Zurich
8091 Zurich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Eva Breuer, MD
Phone: 0041 43 253 78 26
E-Mail: eva.breuer@usz.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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

Secondary outcome:

1. 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

2. 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

3. 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

Studien-Arme

Active Comparator: Painting art therapy
Intervention group
Sham Comparator: Usual Care
Control group

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov

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