Clinical trial · Interventional
Graphic Novel for Patients Undergoing EUS-FNB
Graphic Novel on Anxiety and Stress in Patients Undergoing Endoscopic Ultrasound With Fine Needle Biopsy (EUS-FNB) for Pancreatic Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Endoscopy with endoscopic ultrasound (EUS) is a primary technique for diagnosing and treating severe pancreatic disorders. However, the procedure can cause fear and anxiety in patients, especially when a biopsy is involved. Graphic medicine, a form of visual storytelling that explores narratives of healthcare, is being used to alleviate this anxiety. This is a prospective single-center interventional pilot study with the aim to evaluate the impact of a novel graphic on the stress and behaviors of patients with pancreatic lesions undergoing EUS-FNB. The study will run for six months with the aim to enroll patients to llok for differences in the anxiety and stress levels. Enrolled patients will be randomly allocated to the test or control group, with the test group receiving a graphic novel to read while waiting for the procedure. Post-procedure, patients will complete the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14 (modified Anxiety Stress Scales-14), to assess anxiety and stress levels. This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cystic Lesions | — | UNRESOLVED | — |
| Stress | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Graphic novel visualization | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard procedure informative
- description
- Patients in this group undergo procedure with standard explanation of the procedure itself, so they do not receive and visualize graphic novel.
- type
- EXPERIMENTAL
- label
- Graphic novel visualization
- description
- Patients in this group do receive and visualize graphic novel in addition to standard explanation of the procedure.
- interventionNames
- Behavioral: Graphic novel visualization
Primary outcomes (2)
- measure
- Anxiety and stress level according to BAI
- timeFrame
- up to hospital discharge, approximately up to 12 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. age ≥ 18 years 2. pancreatic solid mass or partially solid in case of cystic component 3. agree to participate in the study by signing the informed consent, and the ability to read and understand informed consent 4. patients not affected by any known psychological disorder. Exclusion criteria: 1. patients with cognitive deficits, such that they cannot adequately complete the questionnaire and the visually impaired 2. suspected or obvious pregnancy status in female subjects 3. patients using benzodiazepines or other psychotropic medications 4. patients with previous diagnosis of cancer.
References
Publications (0)
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