Video Assisted Education Before ERCP

Study Overview
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Brief Summary
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It was aimed to study the effect of video assisted education about endoscopic retrograde cholangiopancreaticography (ERCP) on anxiety levels of patients who planned to undergo ERCP for any reason.Video revealing the ERCP procedure was shown to the patients in one group and not shown to the other. Then anxiety levels and pain scores have been obtained before and after the procedure in both groups

Detailed Description
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The study was conducted to determine the effect of video education on anxiety level before the ERCP procedure and satisfaction degree after the ERCP procedure between September 1st 2017 and December 31st 2018 at Bagcilar Medipol Mega University Hospital. Patients were grouped into two in a randomized manner. In control arm, patients underwent ERCP procedure with the information provided by the gastroenterologist who recommended the procedure. Patients in experimental arm, besides the information provided by the gastroenterologist, watched video of ERCP procedure and answered all the questions about the procedure by an experienced nurse. A total of 70 patients (35 in each arms) was planned to enroll to the study. State-Trait Anxiety Inventory (STAI) form was applied to measure anxiety level and visual analog score (VAS) was applied to measure the satisfaction about the procedure.

Official Title
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Determining the Effect of Video Assisted Education on Anxiety Level and Satisfaction Before ERCP Procedure

Conditions
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Patient Compliance

Intervention / Treatment
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* Behavioral: Video education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years old Conscious enough to understand the procedure and education Patients who can read Hemodynamically stable patients Mentally stable patients Patients who gave informed consent Exclusion Criteria: Patients who underwent previous ERCP procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video education<br>A video of ERCP procedure has been viewed to the patients who will undergo ERCP and questions about the procedure had been answered by the primary investigator (experienced endoscopy nurse) | Behavioral: Video education<br>* Procedure was presented to the cases via a video showing the steps in ERCP and questions had been answered by an experienced nurse<br>|
| No Intervention: Direct ERCP<br>Patients arranged ERCP for any reason underwent directly to the ERCP without any video education. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety status of the patients after ERCP | This will be measured with Stait Trait Anxiety Inventory. There are 2 subscales within this measure. The State Anxiety Scale (S-Anxiety) evaluates the current state of anxiety, asking how respondents feel right now, using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. The Trait Anxiety Scale (T-Anxiety) evaluates relatively stable aspects of anxiety proneness, including general states of calmness, confidence, and security. The STAI has 40 items, 20 items allocated to each of the subscales. Responses for the S-Anxiety scale assess intensity of current feelings at this moment: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the T-Anxiety scale assess frequency of feelings in general: 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. | an hour before ERCP and an hour after ERCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction assessed by visual analogue scale | A VAS for satisfaction is a horizontal line of 100-mm long. At the beginning and at the end, there are two descriptors representing extremes of satisfaction (i.e. no satisfaction and extreme satisfaction). The patient rated his satisfaction by making a vertical mark on the 100-mm line. The measurement in millimetres was converted to the same number of points ranging from 0 to 100 points. | an hour after ERCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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video education, ERCP, anxiety level, pain score