Lower Gastrointestinal Neoplasms BenignNCT04524260
The Effects of Perioperative Painting Art Therapy (LOM® Solution Centered Art Therapy) in Surgical Patients
A study testing perioperative painting art therapy (LOM® solution centered art therapy) in people with Lower Gastrointestinal Neoplasms Benign and Pancreas Cancer, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Gastrointestinal Neoplasms Benign, Pancreas Cancer, Posttraumatic Stress Disorder
- What is being tested?
- perioperative painting art therapy (LOM® solution centered art therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Aug 2020to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Visceral- and Transplantation Surgery, University Hospital Zurich
Zurich, Canton of Zurich, 8091
Eva Breuer, MD, 0041 43 253 78 26, eva.breuer@usz.ch
About this study
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
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.
Read the 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
- Being tested
- perioperative painting art therapy (LOM® solution centered art therapy), perioperative painting art therapy (LOM® solution centered art therapy) - control
- Keywords
- painting art therapy, PTSD, alternative/complementary medicine, anxiety
- Medical subject headings
- Pancreatic Neoplasms, Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perioperative painting art therapy (LOM® solution centered art therapy)Behavioural
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) - controlBehavioural
"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.
| Study group | Role | What they receive |
|---|---|---|
| Painting art therapy | Active comparator | Intervention group Receives: Behavioral: perioperative painting art therapy (LOM® solution centered art therapy) |
| Usual Care | Sham comparator | Control group Receives: Behavioral: perioperative painting art therapy (LOM® solution centered art therapy) - control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline STAI-Score up to 6 months post surgery
Secondary outcomes (3)
Change of Depression
PHQ-9 ("Brief Patient Health Questionnaire-9"), scores ranging from 0 to 27, with higher scores correlating with greater depression
Measured: Change from Baseline PHQ-9-Score up to 6 months post surgery
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
Measured: Change from Baseline PROMIS 29-Scores up to 6 months post surgery
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
Measured: Change from Baseline SF-12-Scores up to 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start31 Aug 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Gastrointestinal Neoplasms BenignStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Alain Clavien, MD PhD, Study chair, Department of Visceral- and Transplantation Surgery, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524260
- Sponsor's protocol ID
- PAINT - Zurich
- Other IDs
- 2019-00643, SNCTP000003688, 2019
- Status last verified
- Feb 2021
- First submitted
- 19 Mar 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04524260
- Acronym / sponsor ID
- PAINT - Zurich
- Conditions
- Lower Gastrointestinal Neoplasms Benign, Pancreas Cancer, Posttraumatic Stress Disorder, Depression, Anxiety
- Keywords
- painting art therapy, PTSD, alternative/complementary medicine, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Painting art therapy | Active comparator | Behavioral: perioperative painting art therapy (LOM® solution centered art therapy)Intervention group |
| Usual Care | Sham comparator | Behavioral: perioperative painting art therapy (LOM® solution centered art therapy) - controlControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Painting art therapy |
| 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. | Behavioural | Usual Care |
Primary outcome
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
3 secondary outcomes
Change of Depression
Time frame: 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
Change of Health related quality of life - SF-12
Time frame: Change from Baseline SF-12-Scores up to 6 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Alain Clavien, MD PhD study chair
Department of Visceral- and Transplantation Surgery, University Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perioperative painting art therapy (LOM® solution centered art therapy) in people with Lower Gastrointestinal Neoplasms Benign and Pancreas Cancer, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Breuer, MD (0041 43 253 78 26, eva.breuer@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Anxiety (time frame: Change from Baseline STAI-Score up to 6 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.