Video Assisted Education Before ERCP

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

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

Study Overview

• Status: Completed
• Conditions: Patient Compliance
• Intervention / Treatment: Behavioral: Video education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İstanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Video education; 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; Procedure was presented to the cases via a video showing the steps in ERCP and questions had been answered by an experienced nurse
NO_INTERVENTION: Direct ERCP; Patients arranged ERCP for any reason underwent directly to the ERCP without any video education.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: Leyla Cevik, RN, Medipol University; Study Chair: Selda Rızalar, Assoc Prof, Medipol University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): August 7, 2019

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (ACTUAL): March 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: ERCP; pain score; video education; anxiety level
• Other Study ID Numbers: ERCPvideo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No