Effect of Patient Anxiety Level Prior to Undergoing ERCP and Procedure Tolerability and Outcomes.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMandip Rai
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥18 years
Undergoing ERCP for any indication with conscious sedation
Able to provide informed consent
Disqualifiers
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
Trial population
Adult patients undergoing clinically indicated ERCP at KHSc, who are able to provide informed consent and complete study questionnaires. Participants will be enrolled prospectively during the study period.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not applicable- observational study
Other interventionNot applicable - observational study
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Patients undergoing ERCP1 intervention
Trial outcomes
Primary outcomes
1
Impact of pre-procedural anxiety on patient experience of ERCP
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).
Time frame
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.Secondary outcomes
1
Factors Associated with Patient Experience
Identification of baseline demographic, clinical, and procedural factors associated with patient experience domains Varibles: Gender Inpatient Outpatient Charleson Comorbidity Index History of anxiety History of depression Indication for procedure Baseline Opioid Use Smoking status Cannabis use Other recreational drugs Alcohol use
Time frame
baseline, pre-procedure2
Procedural Success and Early Termination
Rates of procedural success and early termination
Time frame
Recorded immediate post procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: