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Completed

NCT Number: NCT04291807

Video Assisted Education Before ERCP

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

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Key information

Conditions

Patient Compliance Behavior Health Behavior Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video Education

Behavioral

Procedure was presented to the cases via a video showing the steps in ERCP and questions had been answered by an experienced nurse

Primary outcomes

  1. Change in anxiety status of the patients after ERCP

    Time frame: an hour before ERCP and an hour 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.

Secondary outcomes

  1. Satisfaction assessed by visual analogue scale

    Time frame: an hour after ERCP

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 2, 2020
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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