- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02428907
Simulation Training of Endoscopy Staff to Improve Patient Experience in Colonoscopy
February 1, 2018 updated by: Aalborg University Hospital
Simulation Based Team Training of Endoscopy Staff May Improve Patients' Perception of Colonoscopy
Some patients experience a degree of pain and discomfort during endoscopic examination of the large bowel.
Sedatives and analgesics may be administered in low doses.
Excessive dosage or intense pain may lead to hypotension and impaired level of consciousness.
The purpose of the present study was to determine if simulation training of endoscopy staff in preventing pain and handling acute complications through effective teamwork could improve the quality of colonoscopy from the patients' perspective.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was carried out in a surgical department, where colonoscopies were performed on an out-patient basis under minimal sedation.
The intervention consisted of a simulation based course for endoscopy staff.
All endoscopy nurses and doctors participated (n=43).
The course consisted of three short lectures followed by simulation training.
The lectures dealt with technical aspects of colonoscopy, usage of medication and management of unexpected emergency events during the procedure, and finally with interprofessional teamwork and team communication.
The lectures were followed by in situ simulation in an endoscopy room.
For 2 months before and after the course a questionnaire based survey was carried out.
The respondents were consecutive patients who had undergone colonoscopy under minimal sedation or no sedation (according to their own preference ).
The questionnaire was filled out when the patient was fully recovered after sedation and ready to go home.
The relevant nursing staff and doctor for the procedure also filled out their part of the questionnaire.
Patients were invited to participate and gave written consent after oral and written information according to the Helsinki declaration .
Study Type
Observational
Enrollment (Actual)
539
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aalborg, Denmark, 9000
- NordSim, Aalborg University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients for colonoscopy under minimal sedation
Description
Inclusion Criteria:
- All patients for colonoscopy under minimal sedation who are able to understand imformation
Exclusion Criteria:
- Unable to understand information
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient perception of colonoscopy
Time Frame: 3 months
|
comparison of patient satisfaction aspects of colonoscopy before and after a simulation, course for staff.
The patients fill out a questionnaire: Pain score on a visual analogue scale, Wiilingness to return for a repeat colonoscopy if necessary on a visual analogue scale, assessmment of doctor's and nurse's behaviour on a scale from 1 - 10 regarding empathy, quality of information.
Staff answer a questionnaire where they assess the quality of teamwork on a scale from 1-10.
They also assess the patients perceived pain on a visual analogue scale.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Staff perception of teamwork
Time Frame: 3 months
|
comparison of staff's perception of quality of teamwork before and after a simulation course
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen L Larsen, m.d., Medical Doctor and head of department at Aalborg University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
February 18, 2015
First Submitted That Met QC Criteria
April 24, 2015
First Posted (Estimate)
April 29, 2015
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
February 1, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-58-0028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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