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

NCT04524260 | Unknown DMC

• 3 other identifiers: PAINT - Zurich2019-00643SNCTP000003688
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

painting art therapy; PTSD; alternative/complementary medicine; anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of Depression

  Change from Baseline PHQ-9-Score up to 6 months post surgery

• Change of Quality of Life - PROMIS 29

  Change from Baseline PROMIS 29-Scores up to 6 months post surgery

• Change of Health related quality of life - SF-12

  Change from Baseline SF-12-Scores up to 6 months post surgery

Other Outcomes (14)

• Change of Postoperative Pain 1

  Change from Baseline (NRS pain 0-10) at 6 months post surgery

• Change of Postoperative Pain 2

  Change from Baseline (amount of analgesia) at 6 months post surgery

• Change of Blood pressure

  Change from Baseline at 6 months post surgery

Study Arms (2)

Painting art therapy

ACTIVE COMPARATOR

Intervention group

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

Usual Care

SHAM COMPARATOR

Control group

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

Interventions

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

Painting art therapy

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Visceral- and Transplantation Surgery, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Pierre-Alain Clavien, MD PhD

  Department of Visceral- and Transplantation Surgery, University Hospital Zurich

  STUDY CHAIR

Central Study Contacts

Eva Breuer, MD

CONTACT

0041 43 253 78 26; eva.breuer@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: August 24, 2020
• Study Start: August 31, 2020
• Primary Completion: August 31, 2022
• Study Completion: February 28, 2023
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)