Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT04524260
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.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04524260
Study Brief:
Protocol Section:
NCT04524260