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

Condition(s) studied

Investigational drug(s) / intervention(s)

Not applicable- observational study: Not applicable - observational study

Study summary

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.

Eligibility

Primary outcome measure(s)

• Impact of pre-procedural anxiety on patient experience of ERCP — STAY-Y measured perioperatively/periprocedurally. PROSTEP measured immediately after the procedure once the patient is awake and ready for DC. PROSAS measured immediately post procedure.
  The primary outcome will be the impact of pre-procedural anxiety level measured by the State-Trait Anxiety Inventory (STAI-Y), on the tolerability of ERCP using conscious sedation measured by the patient- reported scale for tolerability of endoscopic procedures (PRO-STEP) and procedure cooperation measured by the Procedural Sedation Assessment Survey (PROSAS).

Trial sites (1)

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