NCT02428907

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
539

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

February 18, 2015

Last Update Submit

February 1, 2018

Conditions

Keywords

simulation trainingminimal sedationcolonoscopypatient satisfactionteamworkteam trainingpatient safety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Staff perception of teamwork

    3 months

Interventions

teamtraining of endoscopy staff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients for colonoscopy under minimal sedation

You may qualify if:

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

You may not qualify if:

  • Unable to understand information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NordSim, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Colorectal NeoplasmsPatient Satisfaction

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Karen L Larsen, m.d.

    Medical Doctor and head of department at Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2015

First Posted

April 29, 2015

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

April 1, 2013

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations