An interventional study of Video education in Patient Compliance, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-03-02.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Other
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
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.
Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
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
Patients arranged ERCP for any reason underwent directly to the ERCP without any video education.
Procedure was presented to the cases via a video showing the steps in ERCP and questions had been answered by an experienced nurse
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.
Time frame: an hour before ERCP and an hour after ERCP
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.
Time frame: an hour after ERCP
Plan to share: No
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Istanbul Medipol University Hospital