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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02428907
Other study ID # 2008-58-0028
Secondary ID
Status Completed
Phase N/A
First received February 18, 2015
Last updated February 1, 2018
Start date October 2012
Est. completion date April 2013

Study information

Verified date February 2018
Source Aalborg Universitetshospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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 .


Recruitment information / eligibility

Status Completed
Enrollment 539
Est. completion date April 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients for colonoscopy under minimal sedation who are able to understand imformation

Exclusion Criteria:

- Unable to understand information

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
simulation training
teamtraining of endoscopy staff

Locations

Country Name City State
Denmark NordSim, Aalborg University Hospital Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary patient perception of colonoscopy 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 Staff perception of teamwork comparison of staff's perception of quality of teamwork before and after a simulation course 3 months
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