Video Assisted Education Before ERCP

NCT04291807 | Completed

• 1 other identifier: ERCPvideo
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patient Compliance

Keywords

video education; ERCP; anxiety level; pain score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Satisfaction assessed by visual analogue scale

  an hour after ERCP

Study Arms (2)

Video education

EXPERIMENTAL

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

Direct ERCP

NO INTERVENTION

Patients arranged ERCP for any reason underwent directly to the ERCP without any video education.

Interventions

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

Video education

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who underwent previous ERCP procedure

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

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

Study Officials

• Leyla Cevik, RN

  Medipol University

  PRINCIPAL INVESTIGATOR

• Selda Rızalar, Assoc Prof

  Medipol University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nurse

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: March 2, 2020
• Study Start: September 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: August 7, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)