Development and Validation of the Saint Paul's Endoscopy Comfort Scale (SPECS) for Colonoscopy and Upper Endoscopy

October 24, 2017 updated by: Robert Enns, University of British Columbia

Do You Have Your SPECS in Order? Development and Validation of the Saint Paul's Endoscopy Comfort Scale (SPECS) for Colonoscopy and Upper Endoscopy

The investigators created the St. Paul's Endoscopy Comfort Score (SPECS) which includes the frequency of verbal cues, body positioning and anxiety levels with descriptions for each of the variables. Our objective is to compare the SPECS, NAPCOMs, NPAT and GS amongst different observers and to determine any correlation with patient satisfaction.

Study Overview

Status

Completed

Conditions

Detailed Description

Colonoscopy is used for the diagnosis and treatment of colonic lesions as well as screening and follow up of patients at risk of developing colorectal cancer. With the increasing demand for colonoscopies, the number of procedures performed in recent years has increased dramatically (Bjorkman & Popp Jr., 2006). Given that performance of a high quality colonoscopy is dependent on the expertise and technical skills of the endoscopist, quantitative and reliable methods for measurement of the quality of colonoscopy are needed. Although other colonoscopy quality indicators, such as adenoma detection rate, have been studied comprehensively (Rex, et al., 2006), patient comfort as a measure of endoscopic quality performance has not been thoroughly assessed.

Study Type

Observational

Enrollment (Actual)

350

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • St. Paul's Hospital

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatients referred to Saint Paul's Hospital for colonoscopy and upper endoscopy

Description

Inclusion Criteria:

  • Age 19 years or older
  • Outpatients referred to Saint Paul's Hospital for colonoscopy and upper endoscopy
  • Capable of reading and understanding English

Exclusion Criteria:

  • Patients who undergo colonoscopy and upper endoscopy in the same appointment

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
Inter-observer reliability
Time Frame: 15-30 minutes
To determine the inter-observer reliability for the SPECS amongst observers and the different comfort scores, NAPCOMS, GS and NPAT.
15-30 minutes
Correlation with patient's reported pain
Time Frame: 10-15 minutes
To determine the correlation of SPECS, NAPCOMS, GS and NPAT with post-procedure patient reported pain and satisfaction controlling for sedation.
10-15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

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.

General Publications

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 (Actual)

September 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • H14-01714

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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