Effect of Patient Anxiety Level Prior to Undergoing ERCP and Procedure Tolerability and Outcomes. (NCT07699731)
The Effect of Pre-procedural Anxiety Level on Procedure Tolerability and Quality of ERCP in Consciously Sedated Patients
🩺 Plain-English Summary (8th-Grade Level)
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: Review the eligibility criteria below.
Location: Kingston Health Sciences Centre — Kingston, Ontario
Age range: 18 Years
🧪 Interventions in This Study
- Not applicable- observational study (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Kingston Health Sciences Centre — Kingston, Ontario
📞 Contact the Study Coordinator
Phone: (403) 585-0249
Email: dain.kim@queensu.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.