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

NCT ID: NCT04524260

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2023-02-28

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.

Conditions

Lower Gastrointestinal Neoplasms Benign; Pancreas Cancer; Posttraumatic Stress Disorder; Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Painting art therapy

Intervention group

Group Type: ACTIVE_COMPARATOR

perioperative painting art therapy (LOM® solution centered art therapy)

Intervention Type: BEHAVIORAL

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

Usual Care

Control group

Group Type: SHAM_COMPARATOR

perioperative painting art therapy (LOM® solution centered art therapy) - control

Intervention Type: BEHAVIORAL

"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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Alain Clavien, MD PhD

Role: STUDY_CHAIR

Department of Visceral- and Transplantation Surgery, University Hospital Zurich

Locations

Department of Visceral- and Transplantation Surgery, University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Eva Breuer, MD

Role: CONTACT

eva.breuer@usz.ch

0041 43 253 78 26

Facility Contacts

Eva Breuer, MD

Role: primary

eva.breuer@usz.ch

0041 43 253 78 26

Other Identifiers

2019-00643

Identifier Type: OTHER

Identifier Source: secondary_id

SNCTP000003688

Identifier Type: OTHER

Identifier Source: secondary_id

PAINT - Zurich

Identifier Type: -

Identifier Source: org_study_id