Effect of Patient Anxiety Level Prior to Undergoing ERCP and Procedure Tolerability and Outcomes.

What this study is about

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a specialized procedure combining upper GI endoscopy and x-rays to treat hepatopancreaticobiliary diseases. Patient experiences after ERCP has been relatively understudied. The goal of this prospective observational study is to understand how anxiety before ERCP affects patient experience and tolerance of the procedure. This study includes adults (18 years and older) undergoing ERCP with conscious sedation at Kingston Health Sciences Centre. Researchers will measure pre-procedure anxiety and examine how it relates to patient comfort, cooperation during the procedure, and overall patient-reported experience. The main questions are whether higher pre-procedure anxiety is associated with lower procedure tolerability and reduced cooperation during ERCP. Participants will: 1. Complete a short anxiety questionnaire before the procedure 2. Undergo ERCP with standard sedation as planned by their care team 3. Complete a post-procedure questionnaire about comfort, pain, and other symptoms 4. Have procedure details and outcomes recorded from medical records Endoscopists will also complete a short survey to state any concerns prior to procedure as well as evaluate patient's cooperation during the procedure. Patient-reported experience will be compared with physician assessments of cooperation during the procedure. Findings may help recognize patients at higher risk of distress during ERCP and guide strategies to improve comfort, sedation planning, and overall procedure quality to lead to the best outcomes.

Who can join (things the study team will check)

✅ You may be able to join if…

• Adults aged ≥18 years
• Undergoing ERCP for any indication with conscious sedation
• Able to provide informed consent

🚫 You may not be able to join if…

• Age <18 years
• Inability or refusal to provide informed consent
• Cognitive impairment or language barriers precluding questionnaire completion
• Emergent ERCP where pre-procedural questionnaire administration is not feasible

Where this trial is running

• Kingston Health Sciences Centre, Kingston, Ontario, Canada

Who to contact

Dain R Kim, MSc, MD · 4035850249 · dain.kim@queensu.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07699731.